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	02/28/2025
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 mitek or its employees that the report constitutes an admission that the device, 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.Device was used for treatment, not diagnosis.E1: the reporter¿s complete facility name was not provided.Investigation summary: 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.Device history record review: a device history record review was performed which indicated that there was a non-conformance unrelated to the reported malfunction.All the issues identified were resolved prior to product release.
Event or Problem Description
It was reported that during a hand surgery, it was discovered that the anchor on the micrifxqa+ w/#4oc c1 device pulled out while the surgeon was performing the flip fixation.It was not reported if there were any delays to the surgical procedure.It was reported that a spare device was used to complete the surgery.There was patient involvement reported.There were no reports of injuries, medical intervention or prolonged hospitalization.All available information has been disclosed.
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 mitek or its employees that the report constitutes an admission that the device, 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.Device was used for treatment, not diagnosis.H11: additional narrative: investigation summary: 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.Upon visualization under magnification, no damage could be observed on the anchor, the anchor and suture had foreign matter, presumably biological matter.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 can be 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 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.
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 mitek or its employees that the report constitutes an admission that the device, 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.Device was used for treatment, not diagnosis.H11: additional narrative: d9, h3, h6: the actual device has been returned and is currently pending evaluation.Once the investigation has been completed, and if additional information should become available, a supplemental medwatch report will be submitted accordingly.

• 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: 21642988
• Report Number: 1221934-2025-00997
• Device Sequence Number: 20736651
• Product Code: JDR
• UDI-Device Identifier: 10886705001903
• UDI-Public: (01)10886705001903(10)233L155(17)261031
• 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): 03/19/2025

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: 233L155
• 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: 03/12/2025
• Supplement Date Received by Manufacturer: 04/02/2025; 04/04/2025
• Initial Report FDA Received Date: 03/19/2025
• Supplement Report FDA Received Date: 04/02/2025; 04/04/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/14/2023
• 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