MAUDE Adverse Event Report: DEPUY MITEK LLC US RAPIDLOC MALLEABLE GRAFT RETRACT *PK/5; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Catalog Number	232024
Medical Device Problem Codes	Break (1069); Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/05/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during an unspecified surgery, it was observed that before suturing the meniscus, the rapidloc malleable graft retract device was bent to facilitate the entry of the truespan and it broke.There was no delay in the procedure reported.There were no adverse patient consequences reported.No additional information was provided.
Additional Manufacturer Narrative
This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by depuy synthes, or its employees that the report constitutes an admission that the product, depuy synthes, 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 report, a follow-up report will be filed as appropriate.H11 additional narrative: the product was not returned to j&j medtech orthopaedics, however a photo was provided for evaluation.Visual inspection of the returned photo found that the malleable graft retractor is shown in used condition.The retractor shows bent and broken at the middle.No other anomalies were noted.The overall complaint was confirmed as the observed condition of the rapidloc malleable graft retract *pk/5 would have contributed to the complained device issue.¿ based on the investigation findings, the potential cause is traced to procedural variables, such handling of the device or product interaction during procedure; malleable graft retractors are designed for easy bending, however a repeated bending will cause metal fatigue causing the retractor to break; as per ifu; inspect for damage prior to use.Replace a damaged, worn or bent instrument.Do not attempt to straighten, sharpen or repair.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.

• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): DEPUY MITEK LLC US; 325 paramount drive; raynham MA 02767
• Manufacturer Contact: kate karberg ; 325 paramount drive; raynham, MA ; 3035526892
• MDR Report Key: 23567698
• Report Number: 1221934-2025-04390
• Device Sequence Number: 18672005
• Product Code: LXH
• UDI-Device Identifier: 20886705010964
• UDI-Public: (01)20886705010964(10)2212546
• 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): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 11/17/2025

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: 232024
• Device Lot Number: 2212546
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/05/2025
• Initial Report FDA Received Date: 11/17/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/29/2022
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown