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

Model Number	86-9117
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/15/2022
Type of Reportable Event	Malfunction
Event or Problem Description
Intrasurgically, it was identified the long pin for femoral fixation was twisted; it could not be used.If this instrument remains so inside the equipment, it could have caused failures in the instrument fixation and discomfort for the specialist.There was no harm to the patient or delays in the procedure.
Additional Manufacturer Narrative
Product complaint #: (b)(4).Investigation summary: the device associated with this report was not returned to depuy synthes for evaluation.The photo investigation found a pin slightly deformed and bent, confirming the reported allegation.Additionally, signs of wear can be seen.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post-market safety surveillance activities.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 information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: PFC 3INHDLES STEINMN PIN PKG10
• Common Device Name: BONE SCREWS AND PINS : FIXATION PINS
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• Manufacturer (Section G): DEPUY ORTHOPAEDICS, INC. 1818910; 700 orthopaedic dr.; warsaw IN 46581 0988
• Manufacturer Contact: kate karberg ; 700 orthopaedic dr.; warsaw, IN 46581-0988 ; 3035526892
• MDR Report Key: 16302899
• Report Number: 1818910-2023-02858
• Device Sequence Number: 12463328
• Product Code: LXH
• UDI-Device Identifier: 10603295218142
• UDI-Public: 10603295218142
• Combination Product (Y/N): N
• Initial Reporter Country: CO
• 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
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 02/06/2023

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 Model Number: 86-9117
• Device Catalogue Number: 869117
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/03/2023
• Initial Report FDA Received Date: 02/06/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown