MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US TRUMATCH; FIXATION PINS

Catalog Number	420907
Medical Device Problem Codes	Device-Device Incompatibility (2919); No Apparent Adverse Event (3189)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	01/01/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Approved.H11: upon further review of the information provided, this mrn was submitted in error.No further reports will be submitted against this mrn.
Additional Manufacturer Narrative
Product complaint # (b)(4).Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.If the information is unknown, not available or does not apply, the section/field of the form is left blank.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
Event or Problem Description
It was reported that the scrub techs were having issues attaching the 2-pronged attachment piece to the tibial pin blocks because the holes seem to be manufactured smaller than previously.It has also created issues for the surgeons not being able to visualize their alignment and slope because the metal piece won¿t sit flush.A couple of blocks have broken at that juncture, as the scrub techs use metal instruments attempting to tap it in flush.

• Brand Name: TRUMATCH
• Common Device Name: FIXATION PINS
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• Manufacturer Contact: elba bello ; 700 orthopaedic dr.; warsaw, IN 46581 ; 9083863534
• MDR Report Key: 24916572
• Report Number: 1818910-2026-07088
• Device Sequence Number: 9827339
• Product Code: JWH
• UDI-Device Identifier: 10603295384823
• UDI-Public: (01)10603295384823(10)00161875
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K110397
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,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 Expiration Date: 08/31/2026
• Device Catalogue Number: 420907
• Device Lot Number: 00161875
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 03/20/2026
• Supplement Date Received by Manufacturer: 04/23/2026
• Initial Report FDA Received Date: 04/17/2026
• Supplement Report FDA Received Date: 04/24/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/17/2026
• 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: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown