MAUDE Adverse Event Report: DEPUY MITEK LLC US MINI QA+ #2/O OCORD V-5; STAPLE, FIXATION, BONE

Catalog Number	212035
Medical Device Problem Codes	Break (1069); Device Damaged Prior to Use (2284); Device-Device Incompatibility (2919); Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/31/2024
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.H11 additional narrative: device history review: there was no non-conformance regarding this lot.The product was returned to j&j medtech orthopaedics for evaluation.The j&j medtech orthopaedics team conducted a visual inspection of the returned device.Visual inspection found that mini qa+ #2/o ocord v-5 had the anchor in the desiccating tray attached to the inserter returned for evaluation.The anchor had one of the arcs missing.Upon visualization under magnification, deep scratches and signs of use could be observed on the anchor and the inserter tip was deformed.No other anomalies could be observed on the device.As the device show signs of use, the reported complaint of failure without use cannot be confirmed.The overall complaint was unconfirmed as the observed condition of the mini qa+ #2/o ocord v-5 would not contribute to the complained device issue.¿ based on the investigation findings, the potential cause for the device condition could be traced to off axis insertion.As per ifu, do not twist or apply bending force to the inserter as either 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 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 the during pre-surgery for an unknown procedure, it was observed when opening the packing that the mini qa+ #2/o ocord v-5 device anchor was detached from the shaft in the package and could not be assembled.During in-house engineering evaluation, it was determined that the one of the devices arcs was missing and the inserter tip was deformed.There were no adverse patient consequences nor surgical delay reported.No additional information was provided.

• Brand Name: MINI QA+ #2/O OCORD V-5
• 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
• Manufacturer Contact: kate karberg ; 325 paramount drive; raynham, MA ; 3035526892
• MDR Report Key: 21353651
• Report Number: 1221934-2025-00524
• Device Sequence Number: 18382367
• Product Code: JDR
• UDI-Device Identifier: 10886705001835
• UDI-Public: (01)10886705001835(10)9L33363(17)250531
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K071257
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 02/11/2025

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 Expiration Date: 05/31/2025
• Device Catalogue Number: 212035
• Device Lot Number: 9L33363
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/22/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/29/2025
• Initial Report FDA Received Date: 02/11/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/08/2022
• 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