MAUDE Adverse Event Report: ZIMMER GMBH ZNN¿¢, CMN LAG SCREW, ø 10.5 MM, 90 MM, INCLUDING SET SCREW; IMPLANT, TRAUMA

Catalog Number	47248509010
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	02/26/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).G2.Report source: china.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 will be submitted.
Event or Problem Description
It was reported that during an initial procedure the connector of znn nail was fractured, leaving a foreign body residue inside the patient.No plan to remove the pieces.Diligence is completed and no further information on the reported event has been provided.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The following sections were updated: b4, g3, g6, h2, h3, h6, h11.No product was returned or pictures provided; a product evaluation could not be performed.The device is still implanted.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.Radiographs were provided and reviewed by a radiologist.The review identified that a single fluoroscopic image of the left hip demonstrate a left femoral intramedullary rod and gamma nail with two metallic fragments noted along the gamma nail at the end near the skin surface.Incomplete evaluation of the femoral fracture.Therefore, a fracture of the lag screw notches can be confirmed.A definitive root cause could not be determined.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
Diligence is completed and no further information on the reported event has been provided.

• Brand Name: ZNN¿¢, CMN LAG SCREW, ø 10.5 MM, 90 MM, INCLUDING SET SCREW
• Common Device Name: IMPLANT, TRAUMA
• 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: 21653766
• Report Number: 0009613350-2025-00153
• Device Sequence Number: 9276628
• Product Code: HSB
• UDI-Device Identifier: 00889024298439
• UDI-Public: (01)00889024298439(17)250531(10)3036080
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K231114
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• 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,Followup
• Report Date (Section B): 03/28/2025

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 05/31/2025
• Device Catalogue Number: 47248509010
• Device Lot Number: 3036080
• 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: 02/26/2025
• Supplement Date Received by Manufacturer: 03/25/2025
• Initial Report FDA Received Date: 03/20/2025
• Supplement Report FDA Received Date: 03/28/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/08/2020
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown