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

Model Number	N/A
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	10/25/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a screw lag reamer was broken during a surgery.The surgeon did not remove the nailing guide and pieces were missing from what was returned to sterilization.It is unknown the harm to the patient.Diligence is completed and no further information on the reported event has been provided.
Additional Manufacturer Narrative
(b)(4).G2.Report source: france.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.
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 reamer was returned for investigation.The shaft of the reamer shows some scratches.The cutting edge of the reamer is fractured.The cutting edge of the reamer is fractured.Two fragments were returned.However, it cannot be confirmed if all fragments are accounted for.The fracture surface of the cutting edge of the reamer shows characteristics indicative of a ductile fracture.The fracture surface was further investigated under a scanning electron microscope, revealing dimples in the matrix and which describe a ductile forced fracture.Additionally, one cross-section in transverse direction was cut for microstructure analysis.The material exhibits a typical martensitic structure with embedded primary carbides and secondary chromium carbides, both fine and course, precipitated throughout the matrix.Further, hardness measurements were performed and found to be within the pre-defined specification.According to this examination, no material issues could be detected.A review of the device manufacturing records confirmed no abnormalities or deviations.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.Review of the surgical technique for the zimmer® natural nail® system states under subsection "nail assembly and insertion" to "remove the guide wire from the nail using the guide wire gripper".Based on the available information, the reported event can be confirmed.According to the correspondence received during the inquiry into how the incident occurred, it was stated that "the surgeon did not remove the nailing guide." as per surgical technique, the guide wire from the nail has to be removed prior to lag screw reaming, as the guide wire can interfere with the reamer.Based on the results of the investigation, the root cause is attributed to user error.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: 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: christina arnt ; 56 e. bell dr.; warsaw, IN 46582 ; 5745273773
• MDR Report Key: 21019993
• Report Number: 0009613350-2024-00623
• Device Sequence Number: 4120281
• Product Code: HSB
• UDI-Device Identifier: 00889024276260
• UDI-Public: (01)00889024276260(11)240325(10)4505035466
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K091566
• 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
• Report Date (Section B): 06/20/2025

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 Model Number: N/A
• Device Catalogue Number: 00249000364
• Device Lot Number: 4505035466
• 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: 12/04/2024
• Supplement Date Received by Manufacturer: 06/17/2025
• Initial Report FDA Received Date: 12/26/2024
• Supplement Report FDA Received Date: 06/20/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/25/2024
• 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