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

Model Number	N/A
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	06/06/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported in a primary surgery that the tip of the lag screw reamer broke and a small piece was left inside the patient.Surgical delay.Diligence is completed and no further information on the reported event has been provided.
Additional Manufacturer Narrative
(b)(4).G2.Report source: south africa.No product was returned.However, one image was provided showing the laser engraving (item# / lot#) of the reported device, but not of the cutter/blade and thus not showing the reported issue.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.Based on the confirmation of the reported event of fracture and retaining in patient with surgical delay received from additional follow-ups, the reported event 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.

• Brand Name: ZNN¿¢, CMN LAG SCREW REAMER, SHORT
• Common Device Name: INSTRUMENT, TRAUMA
• 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: christina arnt ; 56 e. bell dr.; warsaw, IN 46582 ; 5745273773
• MDR Report Key: 20258117
• Report Number: 0009613350-2024-00461
• Device Sequence Number: 15450570
• Product Code: HAW
• UDI-Device Identifier: 00889024276260
• UDI-Public: (01)00889024276260(10)4505035466
• Combination Product (Y/N): N
• Initial Reporter Country: SF
• 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
• Report Date (Section B): 09/19/2024

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?: 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: 09/12/2024
• Initial Report FDA Received Date: 09/19/2024
• 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