MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US PFC 3INHDLES STEINMN PIN PKG10; FIXATION PINS

Catalog Number	869117
Medical Device Problem Codes	Device-Device Incompatibility (2919); Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/18/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product complaint # (b)(4).This report is being submitted pursuant to the provisions of 21 cfr, part 803 (and/or part 4, as applicable).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 medwatch, a follow-up medwatch will be filed as appropriate.
Event or Problem Description
It was reported that during the procedure, it was observed that the six (6) long femur fixation pins included with the equipment were misaligned (quite bent), making it difficult to precisely attach the surgical instruments for the necessary cuts.This occasionally caused minor delays in the surgical procedures, as the pins had to be realigned with the cutting instruments.The surgery was successfully completed without complications for the patient or any alterations to the surgical schedule.
Additional Manufacturer Narrative
Product complaint # (b)(4) investigation summary according to the information received that "during the procedure, it was observed that the six (6) long femur fixation pins included with the equipment were misaligned (quite bent), making it difficult to precisely attach the surgical instruments for the necessary cuts.This occasionally caused minor delays in the surgical procedures, as the pins had to be realigned with the cutting instruments.This caused some discomfort for the specialist; however, the surgery was successfully completed without complications for the patient or any alterations to the surgical schedule.Upon completion, a report was filed in the one force system and on this platform to document the incident.The aforementioned pins were marked with red tape and left inside the equipment for easy identification and replacement when the devices are returned to the j&j facility.The product was not returned to depuy synthes; however, photos were provided for review.See attachment "source file - reporte (b)(6) -(b)(4).¿ the device associated with this report was not returned to depuy synthes for evaluation.The photographs attached were reviewed, however in the images provided no observations pertaining to the event of bent could be identified as they are covered with tape.For the other allegation of unable to assemble the evidence provided was not sufficient to confirm it as functionality and device interaction issues cannot be evaluated through photo investigation.Since the device was not returned, a dimensional inspection cannot be performed.The overall complaint was not confirmed as the photographs attached don¿t have any evidence to draw a conclusion about the reported event.Based on the investigation findings, 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 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.Device history lot a manufacturing record evaluation (nc search) was performed for the finished device product code (869117), lot number (m44n87), and no non-conformances / manufacturing irregularities were identified.

• Brand Name: PFC 3INHDLES STEINMN PIN PKG10
• Common Device Name: FIXATION PINS
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 -098
• Manufacturer Contact: elba bello ; 700 orthpaedic dr.; warsaw, IN 46581 ; 9083863534
• MDR Report Key: 23751120
• Report Number: 1818910-2025-21458
• Device Sequence Number: 12228717
• Product Code: LXH
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative,Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,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: 869117
• Device Lot Number: M44N87
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 09/10/2026
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 11/19/2025
• Supplement Date Received by Manufacturer: 02/01/2026; 09/10/2026
• Initial Report FDA Received Date: 12/08/2025
• Supplement Report FDA Received Date: 02/02/2026; 09/11/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/18/2024
• 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: Female