MAUDE Adverse Event Report: ZIMMER GMBH CMN FEMORAL NAIL, CCD 130°, LEFT, ø 11.5 MM, 38 CM; TAUMA, NAIL

Catalog Number	47249338311
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	03/05/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that after 7 months post implantation, the patient went to a follow-up appointment where it was discovered that the nail fractured at the juncture of the lag screw and will require a revision surgery.Attempts have been made and additional information on the reported event is unavailable at this time.
Additional Manufacturer Narrative
(b)(4).D10: item # 00249004732, 3.2mm threaded pin by 508mm, lot # unknown item # 00249004832, 3.2mm pin by 508mm, lot # unknown item # 00249007543, 4.3mm free hand drill 152.5mm, lot # unknown item # 47249009700, 3mm x 100cm tear drop gd wire, lot # 66461720 item # 47248509510, z nail 10.5 x 95 lag screw, lot # 3189741 item # 47248406550, z nail 5.0x65 cort screw fa, lot # 65862656 item # 47248405250, z nail 5.0x52.5 cort screw fa, lot # 65852867 item # 47248406050, z nail 5.0x60 cort screw fa, lot # 65845459 the device will not be returned for analysis; however, an investigation of the reported event is in progress.Once the investigation is completed, a supplemental medwatch 3500a will be submitted.
Additional Manufacturer Narrative
(b)(4).This follow-up report is being submitted to relay additional information.The following sections were updated: b3, b4, b5, d6b, e1 (establishment name, address - line 1, and telephone number), g3, g6, h2, h6, h11.If any further information is found which would change or alter any conclusions or information, a supplemental will be filed accordingly.Zimmer biomet will continue to monitor for trends.
Event or Problem Description
It was reported patient underwent revision approximately 10 months post implantation due to the nail being fractured at the juncture of the lag screw.Attempts have been made and additional information on the reported event is unavailable at this time.
Event or Problem Description
It was reported patient underwent revision approximately 8 months post implantation due to the nail being fractured at the juncture of the lag screw.Attempts have been made and additional information on the reported event is unavailable at this time.
Additional Manufacturer Narrative
(b)(4): this follow-up report is being submitted to relay additional information.The following sections were updated: b4, g3, g6, h2, h3, h6, h11.Corrected: b3, b5, d6b.No product was returned or pictures provided; a product evaluation could not be performed.A review of the device manufacturing records confirmed no abnormalities or deviations.Review of the complaint history found no additional related complaints for this item and the reported part and lot combination.Based on the available information, the reported event cannot be confirmed and a definitive root cause cannot be established.If any further information is found which would change or alter any conclusions or information, a supplemental will be filed accordingly.Zimmer biomet will continue to monitor for trends.

• Brand Name: CMN FEMORAL NAIL, CCD 130°, LEFT, ø 11.5 MM, 38 CM
• Common Device Name: TAUMA, NAIL
• Manufacturer (Section D): ZIMMER GMBH; sulzer allee 8; sulzer industrie park; winterthur
• Manufacturer (Section G): ZIMMER GMBH; sulzer allee 8; sulzer industrie park; winterthur 8404 ; SZ 8404
• Manufacturer Contact: jennifer rapsavage ; 56 e. bell dr.; warsaw, IN 46582 ; 5745260384
• MDR Report Key: 21622719
• Report Number: 0009613350-2025-00118
• Device Sequence Number: 8446457
• Product Code: HSB
• UDI-Device Identifier: 00889024299894
• UDI-Public: (01)00889024299894(17)330605(10)3149673
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K231114
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Device Explanted Year: 2025
• 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,Followup
• Report Date (Section B): 08/08/2025

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 Catalogue Number: 47249338311
• Device Lot Number: 3149673
• 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: 02/21/2025
• Supplement Date Received by Manufacturer: 06/03/2025; 07/14/2025
• Initial Report FDA Received Date: 03/17/2025
• Supplement Report FDA Received Date: 07/02/2025; 08/08/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/05/2023
• 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: Other
• Patient Sex: Female