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

Catalog Number	869117
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	08/11/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported at the beginning of the procedure, it was identified that a long pin for fixation of the femur is missing.The tibial impactor is fractured during the procedure.The surgery was completed successfully.
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.
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary: according to the information received that "when opening the equipment, at the beginning of the procedure, it is identified missing a long pin for fixation of the femur, notice is given to the surgical instrumentation, and to the person in charge of the surgical warehouse.The tibial impactor is fractured during the procedure.The sagital saw adapter has faults, when making contact with the cortical, the hand piece loses strength.There was no discomfort of the specialist, the surgery ended successfully.¿.The product was not returned to medtech orthopedics; however, photos were provided for review.See attachment "source file -(b)(4)".The photo investigation revealed that ¿869117, pfc 3inhdles steinmn pin pkg10¿ has missing component.The potential cause was traced to delivery service issue.Since the device was not returned, a dimensional inspection cannot be performed.The overall complaint was confirmed as the observed condition would contribute to the complained device issue.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 medtech orthopedics 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 search of the medtech orthopedics nonconformance (nc) quality system found no nc¿s associated with this product<869117>/lot combination.

• 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 0988
• Manufacturer Contact: elba bello ; 700 orthpaedic dr.; warsaw, IN 46581 ; 9083863534
• MDR Report Key: 22907318
• Report Number: 1818910-2025-14877
• Device Sequence Number: 8814361
• Product Code: LXH
• UDI-Device Identifier: 10603295218142
• UDI-Public: (01)10603295218142(10)M44N87
• 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,Health Professional,Company Representative,Distributor
• Initial Reporter Occupation: Other Health Care Professional
• 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 Catalogue Number: 869117
• Device Lot Number: M44N87
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/11/2025
• Supplement Date Received by Manufacturer: 02/01/2026
• Initial Report FDA Received Date: 08/27/2025
• Supplement Report FDA Received Date: 02/02/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/10/2023
• 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: Male