MAUDE Adverse Event Report: Zimmer GmbH Z NAIL CPM 13MM X 34CM 130 L; Implant, Trauma

Catalog Number	47-2493-343-13
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Ambulation or Postural Difficulties (2544)
Date of Event	09/07/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that approximately 12 months post implantation of a cm nail, the patient required revision surgery due to ambulation and imaging demonstrated a fractured nail at the lag screw interface.Attempts have been made and no further information has been provided.
Additional Manufacturer Narrative
(b)(4).G2: foreign - event occurred in canada.The customer has indicated that the product is in process of being returned to zimmer biomet for investigation.Once the investigation has been completed, a follow-up mdr will be submitted.

• Brand Name: Z NAIL CPM 13MM X 34CM 130 L
• Common Device Name: Implant, Trauma
• 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: jennifer rapsavage ; 56 e. bell dr.; warsaw, IN 46582 ; +1(574)526-0384
• MDR Report Key: 50916944
• Report Number: 0009613350-2026-00477
• Device Sequence Number: 5804251
• Product Code: HSB
• UDI-Device Identifier: 00889024299542
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K231114
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2026
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 09/28/2026

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: 47-2493-343-13
• Device Lot Number: 3027057
• 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: 09/07/2026
• Initial Report FDA Received Date: 09/28/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/06/2020
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Sex: Unknown