Devices

11 QS, MDR Violations at Miach Orthopaedics

David McFarland

— 2 min read
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A 3/31-4/23 FDA inspection at the Miach Orthopaedics facility in Westborough, MA, identified 11 Quality System and Medical Device Reporting regulation violations in the firm’s manufacturing of the Bridge-Enhanced ACL Restoration implant intended to treat anterior cruciate ligament injuries. An 8/19 Warning Letter says the specific Quality System violations were:

  • failure to establish and maintain procedures for monitoring and control of process parameters for validated processes to ensure that the specified requirements continue to be met;
  • failure to establish and maintain procedures to control product that does not conform to established requirements;
  • failure to establish and maintain procedures to ensure that the design requirements relating to a device are appropriate and address the device’s intended use, including the needs of the user and patient, and a mechanism for addressing incomplete, ambiguous, or conflicting requirements;
  • failure to ensure that when the results of a process cannot be fully verified by subsequent inspection and test, the process shall be validated with a high degree of assurance and approved according to established procedures;
  • failure to ensure that sampling plans are written and based on a valid statistical rationale when used;
  • failure to establish and maintain the requirements, including quality requirements, that must be met by suppliers, contractors, and consultants, and documented evaluation and selection of potential suppliers, contractors, and consultants based on their ability to meet specified requirements, including quality requirements;
  • failure to establish and maintain procedures for receiving, reviewing, and evaluating complaints by a formally designated unit, including evaluations to determine whether the complaint represents an event that is required to be reported to FDA; and
  • failure to adequately establish and maintain procedures for implementing corrective and preventive action.

The letter says the firm’s responses to the Quality System inspection observations were inadequate.

The specific Medical Device Reporting violations were:

  • failure to adequately develop, maintain, and implement written Medical Device Reporting procedures;
  • failure to submit a report to FDA no later than 30 days after the day Miach received or otherwise became aware of information, from any source, that reasonably suggested that a device the firm markets may have caused or contributed to a death or serious injury; and
  • failure to submit a report to FDA no later than 30 days after the day the firm received or otherwise became aware of information, from any source, that reasonably suggested that a device Miach manufactures has malfunctioned and the device or a similar device that the company markets would be likely to cause or contribute to a death or serious injury if the malfunction were to recur.

Miach was told to act promptly to correct the violations and to respond with a list of specific steps it has taken to address the violations and prevent their recurrence, with documentation of the steps and a schedule for completing the corrections.

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