MAUDE Adverse Event Report: ZIMMER GMBH CM LAG SCREW REAMER - SHORT; INSTRUMENT, TRAUMA

Catalog Number	00-2490-003-64
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Codes	Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that one of the reamers broke but nobody knows when.Attempts have been made and additional information on the reported event is unavailable at this time.
Additional Manufacturer Narrative
(b)(4).G2: foreign source canada.Attempts have been made to gather all product identification information and no further information has been provided.An investigation of the reported event is in progress.Once the investigation is completed, a supplemental medwatch 3500a will be submitted.
Additional Manufacturer Narrative
Follow up report.(b)(4).Updated: b4, b5, d2, d4, g1, g3, g6, h1, h2, h4, h6.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 that one of the reamers broke, the event date is unknown.There was no patient impact.The surgeon looked on the xray and could not see any foreign pieces.Attempts have been made and additional information on the reported event is unavailable at this time.
Event or Problem Description
No additional event information.
Additional Manufacturer Narrative
Follow up report.(b)(4).Updated: b4,b5,d2,d9,g1,g3,g6,h1,h2,h3,h6.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 the 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.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: CM LAG SCREW REAMER - SHORT
• Common Device Name: INSTRUMENT, 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: 22851114
• Report Number: 0009613350-2025-00660
• Device Sequence Number: 4362119
• Product Code: HSB
• UDI-Device Identifier: 00889024276260
• UDI-Public: (01)00889024276260(11)220923(10)4504491713
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K231114
• 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: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/09/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 00-2490-003-64
• Device Lot Number: 4504491713
• 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: 07/31/2025
• Supplement Date Received by Manufacturer: 08/20/2025; 10/03/2025
• Initial Report FDA Received Date: 08/20/2025
• Supplement Report FDA Received Date: 09/09/2025; 10/09/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/23/2022
• 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
• Patient Sex: Unknown