MAUDE Adverse Event Report: DEPUY MITEK LLC US MINILOK QA+ # 2-0 OC V5; FASTENER, FIXATION, BIODEGRADABLE, SOFT TISSUE

Catalog Number	212853
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/13/2025
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.H11 additional narrative: investigation summary: the product has not returned to j&j medtech orthopaedics; however, a photo was provided for evaluation.Visual inspection of the returned photo found the suture with the needles detached from the anchor.The sutures had foreign matter, presumably biological matter.No other anomalies were noted.The overall complaint was confirmed as the observed condition of the minilok qa+ # 2-0 oc v5 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; the potential cause for the suture condition could be traced to the over tension of the suture.As per instructions for use (ifu); 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 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 an unspecified surgical procedure it was observed that the sutures come off the minilok qa+ # 2-0 oc v5 anchor device.Another device was used to successfully complete the procedure.There were no adverse consequences to the patient, or surgical delay.No additional information could be provided.

• Brand Name: MINILOK QA+ # 2-0 OC V5
• Common Device Name: FASTENER, FIXATION, BIODEGRADABLE, SOFT TISSUE
• 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: 22105922
• Report Number: 1221934-2025-01966
• Device Sequence Number: 15491233
• Product Code: MAI
• UDI-Device Identifier: 10886705002429
• UDI-Public: (01)10886705002429(10)279L668(17)270228
• Combination Product (Y/N): N
• Initial Reporter Country: CO
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial

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: 212853
• Device Lot Number: 279L668
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/13/2025
• Initial Report FDA Received Date: 05/29/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/28/2024
• 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): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown