MAUDE Adverse Event Report: DEPUY MITEK LLC US MICROFIX QA+ #3/O ETH V4; SOFT-TISSUE ANCHOR, BIOABSORBABLE

Model Number	212855
Medical Device Problem Codes	Use of Device Problem (1670); Packaging Problem (3007)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/04/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported by the sales rep that the microfix qa+ #3/o eth v4 device was received in a crushed box.During in-house engineering evaluation, it was determined that inserter holding pin was found bent.Another like device was used to complete the procedure.There were no adverse patient consequences nor surgical delay reported.No additional information was provided.
Additional Manufacturer Narrative
Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.Udi: (b)(4).Investigation summary: the complaint device was received and evaluated.The outer box was not returned.The inner foil pouch is completely sealed, no damages can be observed over its surface.The pouch was opened to review the condition of the device, the inserter holding pin was found to be bent.A manufacturing record evaluation was performed for the finished device 8l58022 number, and no non-conformances were identified.As part of depuy synthes mitek quality process all devices are manufactured, inspected, and released to approved specifications.According with the visual inspection result, we can confirm this complaint.Although the outer box was not returned, the device was found with a bending on the inserter pin.The possible root cause can be attributed to the transportation and storage conditions, however, this cannot be conclusively 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.

• Brand Name: MICROFIX QA+ #3/O ETH V4
• Common Device Name: SOFT-TISSUE ANCHOR, BIOABSORBABLE
• Manufacturer (Section D): DEPUY MITEK LLC US; 325 paramount drive; raynham MA 02767
• Manufacturer Contact: kate karberg ; chemin-blanc 38; le locle 02400 ; SZ 02400 ; 3035526892
• MDR Report Key: 14595121
• Report Number: 1221934-2022-01590
• Device Sequence Number: 5530241
• Product Code: MAI
• UDI-Device Identifier: 10886705002443
• UDI-Public: 10886705002443
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K150209
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 06/03/2022

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: 08/31/2024
• Device Model Number: 212855
• Device Catalogue Number: 212855
• Device Lot Number: 8L58022
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/04/2022
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/02/2022
• Initial Report FDA Received Date: 06/03/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/18/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown