MAUDE Adverse Event Report: DEPUY MITEK LLC US MICRO QA+ #4/0 ETH P-3; SOFT-TISSUE ANCHOR, NON-BIOABSORBABLE

Model Number	212867
Medical Device Problem Code	Difficult to Open or Close (2921)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/30/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Udi: (b)(4).Investigation summary: according to the information received, it was reported that during the procedure the device blocked.The surgeon couldn't open the device with the white cord, although she pulled quite hard.The complaint device was received and evaluated.Visual observations reveal that the shaft inserter was broken.The anchor was held in place by the suture.The device was open with a force greater than normal.A manufacturing record evaluation was performed for the finished device lot number: [4l46932], and no non-conformances were identified.The complaint can be confirmed.The possible root cause for the reported failure can be attributed to when the suture was pulled the internal retaining cap gotten up, as result, the cover handle was hard to open and for the shaft broken can be associated with excessive force applied during tensioning of the suture when was pulled.However, this cannot be conclusive determined.At this point in time, no corrective action is required, and no further action is warranted.However, in depuy synthes mitek, additional complaint information monitoring for potential safety signals is conducted through complaint trending as part of post market surveillance.
Event or Problem Description
It was reported by the affiliate in (b)(6) that during an unknown surgery on (b)(6) 2020, it was observed that the micro qa+ #4/0 eth p-3 device was blocked.According to the report, the surgeon could not open the device with the white cord even with a hard force.During in-house engineering evaluation, it was determined that the shaft inserter on the device was broken.Another like device was used to complete the procedure.There were no adverse patient consequences reported.No additional information was provided.

• Brand Name: MICRO QA+ #4/0 ETH P-3
• Common Device Name: SOFT-TISSUE ANCHOR, NON-BIOABSORBABLE
• Manufacturer (Section D): DEPUY MITEK LLC US; 325 paramount drive; raynham MA 02767
• MDR Report Key: 11347945
• Report Number: 1221934-2021-00592
• Device Sequence Number: 3416731
• Product Code: HWC
• UDI-Device Identifier: 10886705002542
• UDI-Public: 10886705002542
• Combination Product (Y/N): N
• Initial Reporter Country: BE
• PMA/510(K) Number: K024115
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 02/18/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 04/30/2024
• Device Model Number: 212867
• Device Catalogue Number: 212867
• Device Lot Number: 4L46932
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/15/2021
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/18/2021
• Initial Report FDA Received Date: 02/19/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1