MAUDE Adverse Event Report: DEPUY MITEK LLC US MINILOK QA+ W/ #0 OCORD AND OS-2 NEEDLE W/BIT; SOFT-TISSUE ANCHOR, BIOABSORBABLE

Model Number	212849
Medical Device Problem Codes	Detachment of Device or Device Component (2907); Material Deformation (2976); Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/04/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported by the sales rep in south korea that during an unknown procedure on (b)(6) 2023, it was observed that the minilok qa+ w/ #0 ocord and os-2 needle w/bit device had an unspecified malfunction.During in-house engineering evaluation, it was determined that the anchor on the device was detached from the inserter tip.It was further determined that the distal end of the inserter on the device was slightly deformed.There were no adverse patient consequences nor surgical delay reported.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.Udi: (b)(4).E3: reporter is a j&j sales representative.Investigation summary: the product was returned to mitek for evaluation.Mitek then conducted visual inspection of device received.Upon visual inspection, it was found that the anchor was detached from the inserter tip.The distal end of the inserter was slightly deformed which created a problem to hold the anchor in place.A manufacturing record evaluation was performed for the finished device lot number: 9l44115, and no non-conformances were identified.Based on the condition of the device received, this complaint can be confirmed.As per ifu: do not twist or apply bending force to the inserter.Doing so may damage the anchor, suture, or inserter tip.Excessive tension may overload the anchor or suture.The possible root cause for the issue reported can be attributed to excessive force and twist applied during procedure.As part of depuy synthes mitek quality process all devices are manufactured, inspected, and released to approved specifications.At this point in time, no corrective action is required, and no further action is warranted.However, depuy synthes mitek will continue to monitor additional complaint information for potential safety signals through complaint trending as part of post market surveillance.

• Brand Name: MINILOK QA+ W/ #0 OCORD AND OS-2 NEEDLE W/BIT
• Common Device Name: SOFT-TISSUE ANCHOR, BIOABSORBABLE
• 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: 16673542
• Report Number: 1221934-2023-01464
• Device Sequence Number: 6445476
• Product Code: MAI
• UDI-Device Identifier: 10886705002382
• UDI-Public: 10886705002382
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• PMA/510(K) Number: K150209
• 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,Company Representative,Distributor
• Initial Reporter Occupation: Other Health Care Professional
• 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 Expiration Date: 05/31/2025
• Device Model Number: 212849
• Device Catalogue Number: 212849
• Device Lot Number: 9L44115
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/10/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/30/2023
• Initial Report FDA Received Date: 04/04/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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