MAUDE Adverse Event Report: DEPUY MITEK LLC US BRISTOW LATARJET; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Catalog Number	285270
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	05/14/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during loan kit product inspection it was observed that the latarjet curved osteotome device was composed of 1 part.It was observed that the bottom metal part of the device had come off from the handle.There was no patient involvement.No additional information could be 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: investigation summary: the product was not returned to depuy synthes; however, a photo was provided for evaluation.Visual inspection of the returned photo revealed that the device is in used condition, as expected for reusable devices.However, the metal impact cap on the handle was found to have fallen off.The observed condition was identified as an end-of-life indicator; damage consistent with repeated use and servicing.The lifecycle requirements of the device are event related and depend on the use and inspection of the device in clinical practice.As the device can be damaged on the first or 100th use, the device must be properly inspected prior to each surgical use.Refer to the device/country specific instructions for use (ifu) for information related to end of life, reprocessing instructions, and inspection procedures.The overall complaint was confirmed as the observed condition of the latarjet curved osteotome would have contributed to the complained device issue.Based on the investigation findings, the potential cause is traced to end of life.As per ifu; inspect the instruments before use for integrity and compatibility in order to ensure proper functionality and safety.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 depuy synthes 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.

• Brand Name: BRISTOW LATARJET
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): DEPUY MITEK LLC US; 325 paramount drive; raynham MA 02767
• Manufacturer Contact: elba bello ; 325 paramount drive; raynham, MA 02767 ; 9083863534
• MDR Report Key: 25322395
• Report Number: 1221934-2026-02238
• Device Sequence Number: 5368817
• Product Code: LXH
• UDI-Device Identifier: 10886705018000
• UDI-Public: (01)10886705018000(10)18F03
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• 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,Followup,Followup,Followup

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: 285270
• Device Lot Number: 18F03
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/15/2026
• Supplement Date Received by Manufacturer: 06/08/2026; 07/08/2026; 07/13/2026
• Initial Report FDA Received Date: 05/28/2026
• Supplement Report FDA Received Date: 06/10/2026; 07/09/2026; 07/14/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): No
• 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