MAUDE Adverse Event Report: DEPUY MITEK LLC US MICRO QA+ #3/0 OC V4; SCREW, FIXATION, BONE

Catalog Number	212843
Medical Device Problem Codes	Use of Device Problem (1670); Migration (4003)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/01/2025
Type of Reportable Event	Malfunction
Event or Problem Description
At the pose, the anchor went out its position in the bone during the suture tensioning and the control.At the inspection of the anchor thereafter, one fin was too short, or even defective.It was reported that at the inspection during an unspecified surgical procedure, during pose, it was observed that the micro qa+ #3/0 oc v4 device went out of position in the bone during suture tensioning and the control.The device had one fin that was too short, or even defective.It was unknown if there were any delays to the procedure reported.There were no reports of injuries, medical intervention or prolonged hospitalization.No additional information was provided.
Additional Manufacturer Narrative
This report is being submitted in pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by depuy mitek or its employees that the report constitutes an admission that the device, depuy mitek, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.H11 additional narrative: as of this date, the device has not been returned for evaluation; therefore, the reported condition cannot be confirmed and/or duplicated.
Additional Manufacturer Narrative
This report is being submitted in pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by depuy mitek or its employees that the report constitutes an admission that the device, depuy mitek, or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.H11 additional narrative: the complaint device was not returned to j&j medtech orthopaedics, therefore unavailable for a physical evaluation.A manufacturing record evaluation was performed for the finished device, and no non-conformance was identified.Based on the current available information, we cannot determine a root cause for the reported failure.If the complaint device is received in the future, we will reopen the complaint and perform the investigation as appropriate.It has been determined that no corrective and/or preventative action is proposed and there is no indication that a design or manufacturing issue has caused the reported complaint condition.As part of j&j medtech orthopaedics quality process, all devices are manufactured, inspected, and released to approved specifications.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post-market safety surveillance activities.

• Brand Name: MICRO QA+ #3/0 OC V4
• Common Device Name: SCREW, FIXATION, BONE
• Manufacturer (Section D): DEPUY MITEK LLC US; 325 paramount drive; raynham MA 02767
• Manufacturer (Section G): MEDOS INT MITEK; chemin blanc 38; le locle CH-02 400; SZ CH-02400
• Manufacturer Contact: kate karberg ; 325 paramount drive; raynham, MA 02767 ; 3035526892
• MDR Report Key: 23335352
• Report Number: 1221934-2025-03909
• Device Sequence Number: 10523999
• Product Code: HWC
• UDI-Device Identifier: 10886705002375
• UDI-Public: (01)10886705002375(10)10556Z(17)291231
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K080352
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/20/2025

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 Catalogue Number: 212843
• Device Lot Number: 10556Z
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/02/2025
• Supplement Date Received by Manufacturer: 10/22/2025
• Initial Report FDA Received Date: 10/20/2025
• Supplement Report FDA Received Date: 10/23/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/05/2024
• 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: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown