MAUDE Adverse Event Report: ZIMMER GMBH ZNN¿¢, CMN LAG SCREW REAMER, SHORT; INSTRUMENT, HIP

Catalog Number	00249000364
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	05/25/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).G2.Report source: canada.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 hip procedure, the tip of the reamer broke off inside the patient during routine cm nail.No harm was reported.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, d9, g3, g6, h2, h3, h6, h11.The lag screw reamer was returned for investigation.The rear end and the shaft of show signs of normal usage and are overall inconspicuous.The cutting edges of the instrument are damaged, and the tip of the reamer is fractured off; the fragments were not returned.A review of the device manufacturing records confirmed no abnormalities or deviations.Surgical technique recommends to "assemble the lag screw trocar into the lag screw cannula and pass through the correct hole in the targeting guide for the chosen ccd angle" and suggest "hole indicators can be placed in static (st) and dynamic (dy) holes of the targeting guide and in holes for ccd angles that will not be used to avoid the occidental use of those holes during the surgery".Review of the complaint history identified additional similar complaints for the reported item and no additional similar complaints for the reported part and lot combination.Complaints are monitored per complaint trending process in order to identify potential adverse trends.Based on the analysis of the returned instrument, a fracture of the tip ca be confirmed.The fractured fragments of the lag screw reamer were not returned.The review of the surgical technique suggests that using the wrong ccd angle during assembly of the lag screw reamer on the targeting guide could potentially lead to an impingement of the tip of the lag screw on the nail, which might contribute to the fracture of the reamer.However, with the available information, it is impossible to reproduce the reported event, and a definitive root cause cannot be established.As per iso 10993-1, the instrument involved is classified as an externally communicating medical device with limited (< 24 hours) contact with bones and tissue.Instructions for use states that ¿any decision to leave or remove broken instruments (e.G., drill fragments) is left to the surgeon¿s ultimate discretion and must take into account the associated risks¿.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 REAMER, SHORT
• Common Device Name: INSTRUMENT, HIP
• 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: 22289678
• Report Number: 0009613350-2025-00450
• Device Sequence Number: 8319653
• Product Code: LZO
• UDI-Device Identifier: 00889024276260
• UDI-Public: (01)00889024276260(10)4505181619
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/07/2025

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: Health Professional
• Device Catalogue Number: 00249000364
• Device Lot Number: 4505181619
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• 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: 05/26/2025
• Supplement Date Received by Manufacturer: 10/06/2025
• Initial Report FDA Received Date: 06/19/2025
• Supplement Report FDA Received Date: 10/07/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/18/2024
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown