MAUDE Adverse Event Report: DEPUY MITEK LLC US MICRIFXQA+ W/#4OC C1; STAPLE, FIXATION, BONE

Catalog Number	212045
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/28/2025
Type of Reportable Event	Malfunction
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 product has not returned to j&j medtech orthopaedics, however photos were provided for review.Visual inspection of the returned photos found that the device was in a used condition and the anchor was detached from the inserter.No other anomalies were noted.The overall complaint was confirmed as the observed condition of the micrifxqa+ w/#4oc c1 would have contributed to the complained device issue.Based on the investigation findings, the potential cause for the reported condition is traced to the procedural variables, such handling of the device or product interaction during procedure, it is possible that the depth penetration of the bone was not maintained; therefore, the anchor did not fully insert, and it was pulled out along with the device.As per ifu, residual bone fragments should be removed from the drilled hole site because they may interfere with proper placement or seating of the anchor.Incomplete insertion or poor bone quality may result in anchor pullout.It has been determined that no corrective and/or preventative action is proposed.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.E1: facility name: (b)(6).
Event or Problem Description
It was reported that during a hand surgical procedure the micrifxqa+ w/#4oc c1 device anchor pulled out.Another like device was used to complete the procedure.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: d9, h6: the actual device has been returned and is currently pending evaluation.Once the investigation has been completed, a supplemental medwatch report will be submitted accordingly.
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 product was returned to j&j medtech orthopaedics for evaluation.Visual inspection of the returned device found the anchor detached from the inserter and still attached to the suture.The suture was broken and frayed.No other anomaly could be observed.The overall complaint was confirmed as the observed condition of the micrifxqa+ w/#4oc c1 would have contributed to the complained device issue.Based on the investigation findings, the potential cause for the device condition is traced to the procedural variables, such handling of the device or product interaction during procedure such as: snaps or other instrument to pull the suture without wrapping the suture around the snaps creates a stress point on the suture, resulting in breaking it.As per ifu, in handling this or any other suture material, care should be taken to avoid damage from handling.Avoid crushing or crimping damage due to application of surgical instruments such as forceps or needle holders.Excessive tension may overload the anchor or suture.It has been determined that no corrective and/or preventative action is proposed.There is no indication that a design or manufacturing issue has caused the 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: MICRIFXQA+ W/#4OC C1
• Common Device Name: STAPLE, FIXATION, BONE
• Manufacturer (Section D): DEPUY MITEK LLC US; 325 paramount drive; raynham MA 02767
• Manufacturer (Section G): DEPUY MITEK LLC US; 325 paramount drive; raynham MA 02767
• Manufacturer Contact: kate karberg ; 325 paramount drive; raynham, MA 02767 ; 3035526892
• MDR Report Key: 22030642
• Report Number: 1221934-2025-01754
• Device Sequence Number: 8112580
• Product Code: JDR
• UDI-Device Identifier: 10886705001903
• UDI-Public: (01)10886705001903(10)260L961(17)261231
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 05/15/2025

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: 212045
• Device Lot Number: 260L961
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/06/2025
• Supplement Date Received by Manufacturer: 05/27/2025; 05/28/2025
• Initial Report FDA Received Date: 05/15/2025
• Supplement Report FDA Received Date: 05/28/2025; 05/30/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/19/2024
• 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: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown