MAUDE Adverse Event Report: ZIMMER GMBH ZNN¿¢, CMN LAG SCREW, ø 10.5 MM, 100 MM, INCLUDING SET SCREW; PROSTHESIS, SCREW

Catalog Number	47248510010
Medical Device Problem Codes	Difficult to Insert (1316); Malposition of Device (2616)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	04/16/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a lag screw and inserter could not fully thread during a procedure.There was a small gap between the inserter and lag screw.The lag screw was able to be implanted but full compression was not achieved.Therefore the lag screw is not serving its intended purpose and is considered a foreign body.The issue was identified intra-operatively during screw placement.Attempts have been made, and no further information has been provided.
Additional Manufacturer Narrative
(b)(4).D10: long cm lag screw inserter cat # 00249000350 lot # 62361350.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.

• Brand Name: ZNN¿¢, CMN LAG SCREW, ø 10.5 MM, 100 MM, INCLUDING SET SCREW
• Common Device Name: PROSTHESIS, SCREW
• 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 ; 5745260384
• MDR Report Key: 25677339
• Report Number: 0009613350-2026-00340
• Device Sequence Number: 17311057
• Product Code: HSB
• UDI-Device Identifier: 00889024298453
• UDI-Public: (01)00889024298453(17)310113(10)3263263
• Combination Product (Y/N): N
• Initial Reporter State: NE
• Initial Reporter Country: US
• PMA/510(K) Number: K091566
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2026
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 07/01/2026

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: Health Professional
• Device Catalogue Number: 47248510010
• Device Lot Number: 3263263
• 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: 06/03/2026
• Initial Report FDA Received Date: 07/01/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/13/2026
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown