MAUDE Adverse Event Report: ZIMMER GMBH CMN FEMORAL NAIL, CCD 130°, RIGHT, ø 11.5 MM, 32 CM; CMN TRAUMA IMPLANT

Model Number	N/A
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Codes	Failure of Implant (1924); Pain (1994)
Date of Event	07/12/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported a patient experienced a right femoral fracture and underwent an orif.Subsequently, developed pain and radiographic imaging displayed a fractured femoral nail.Approximately 3 months later, underwent a revision of the femoral nail system and reimplanted a 6cm longer nail without complication.Due diligence has been completed for this complaint; to date all available additional information has been received.
Additional Manufacturer Narrative
(b)(4).D10: unk screws ¿ distally locked (x3) unknown item and lot # unk cerclage wires (x2) unknown item and lot # g2: foreign: germany the device will not be returned for analysis; however, an investigation of the reported event is in progress.Once the investigation is completed, a follow-up mdr will be submitted.
Event or Problem Description
No additional information at this time.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The following sections were updated/corrected updated: g3; h2; h3; h6 no product was returned or pictures provided; visual and dimensional evaluations could not be performed.A review of the device manufacturing records confirmed no abnormalities or deviations that could be related to the reported event.Review of the complaint history found no additional related complaints for this item and the reported part and lot combination.It was reported a patient experienced a right femoral fracture and underwent an orif.Subsequently, developed pain without trauma and radiographic imaging displayed a fractured femoral nail in the area of the femoral neck screw.Patient underwent a revision of the femoral nail system and re-implanted a 6cm longer nail without complication.Based on the available information, the reported event can be confirmed, however a definitive root cause cannot be established.If any further information is found which would change or alter any conclusions or information, a supplemental report will be filed accordingly.Zimmer biomet will continue to monitor for trend.

• Brand Name: CMN FEMORAL NAIL, CCD 130°, RIGHT, ø 11.5 MM, 32 CM
• Common Device Name: CMN TRAUMA IMPLANT
• Manufacturer (Section D): ZIMMER GMBH; sulzer allee 8; sulzer industrie park; winterthur 8404 ; SZ 8404
• Manufacturer (Section G): ZIMMER GMBH; sulzer allee 8; sulzer industrie park; winterthur 8404 ; SZ 8404
• Manufacturer Contact: christina arnt ; 56 e. bell dr.; warsaw, IN 46582 ; 5745273773
• MDR Report Key: 19937446
• Report Number: 0009613350-2024-00332
• Device Sequence Number: 7319693
• Product Code: HSB
• UDI-Device Identifier: 00889024299320
• UDI-Public: (01)00889024299320(17)290131(10)2981884
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K192312
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/07/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Lay User/Patient
• Device Model Number: N/A
• Device Catalogue Number: 47249332211
• Device Lot Number: 2981884
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/17/2024
• Supplement Date Received by Manufacturer: 11/07/2024
• Initial Report FDA Received Date: 08/08/2024
• Supplement Report FDA Received Date: 11/08/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/15/2019
• 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: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SEE H11 NARRATIVE.
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Sex: Female