MAUDE Adverse Event Report: DEPUY MITEK LLC US MICRIFXQA+ W/#4OC P3; STAPLE, FIXATION, BONE

Catalog Number	212044
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/31/2025
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.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.H11 additional narrative: the product has not returned to j&j medtech orthopaedics; however a photo was provided for review.¿ visual inspection of the returned photo found that the device was in a used condition and the anchor was broken at the proximal end.Foreign matter could be observed on the overall anchor and suture surface, presumably biological matter.No other anomalies were noted.The overall complaint was confirmed as the observed condition of the micrifxqa+ w/#4oc p3 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.The possible root cause can be associated with off axis insertion and levering during insertion.As per ifu- 109285, do not twist or apply bending force to the inserter.Doing so may damage the anchor, suture, or inserter tip.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.
Event or Problem Description
It was reported that during a procedure of temporomandibular arthrectomy + meniscusitis + bilateral condylentolia, at the time the specialist was preparing to use the microfix quicksnchor anchor and when positioning it for use, it was evident that the tip of this was defective (bent), which is why it was not possible to use said reference, so the specialist requested to open another anchor of the same reference and characteristics, which could be used without any problem, thus successfully completing the surgery, without discomfort to the specialist, without affecting the patient and without alterations in surgical times.There were no adverse patient consequences reported.No additional information was provided.

• Brand Name: MICRIFXQA+ W/#4OC P3
• 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: 22786673
• Report Number: 1221934-2025-03050
• Device Sequence Number: 9907035
• Product Code: JDR
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 08/12/2025

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: 212044
• Device Lot Number: 268L367
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 09/14/2026
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/01/2025
• Supplement Date Received by Manufacturer: 09/14/2026; 09/22/2026
• Initial Report FDA Received Date: 08/12/2025
• Supplement Report FDA Received Date: 09/15/2026; 09/24/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/09/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown