MAUDE Adverse Event Report: ZIMMER BIOMET, INC. MG II BONE SCREW DRILL 3.2MMDIA; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT

Catalog Number	00512008500
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	09/22/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).G2: foreign: singapore.H6: proposed component code: mechanical (g04) - drill.Customer has indicated that the product will not be returned as it has been discarded.The investigation is in progress.Upon completion of the investigation, a follow-up mdr will be submitted.
Event or Problem Description
It was reported that during a knee procedure, the drill bit fractured.The fractured fragment was unable to be removed and was left in the patient's femur.No additional intervention or patient impact has been reported as a result of the retained fragment.It was reported that all available information has been provided.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The following sections have been updated: b4; b5; d4; g3; h2; h4; h11.The investigation is in progress.Upon completion of the investigation, a follow-up mdr will be submitted.
Event or Problem Description
No further event information at time of this report.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The following sections have been updated: b4; b5; g3; h2; h3; h4; h6; h11.Visual examination of the provided picture identified the reported device held by a gloved hand.The distal tip of the drill is fractured.The device shows signs of use such as discoloration.Device history record was reviewed and no discrepancies related to the reported event were found.Root cause was unable to be determined.Reported event was confirmed by review of provided photographs.If any further information is found which would change or alter any conclusions or information, a supplemental report will be filed accordingly.Zimmer biomet will continue to monitor for trends.
Event or Problem Description
No further event information at time of this report.

• Brand Name: MG II BONE SCREW DRILL 3.2MMDIA
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 1800 w. center st.; warsaw IN 46580
• Manufacturer (Section G): ZIMMER BIOMET, INC.; 1800 w. center st.; warsaw IN 46580
• Manufacturer Contact: jennifer rapsavage ; 56 e. bell dr.; warsaw, IN 46582 ; 5745260384
• MDR Report Key: 23343108
• Report Number: 0001822565-2025-03797
• Device Sequence Number: 20778538
• Product Code: HTW
• UDI-Device Identifier: 00889024186804
• UDI-Public: (01)00889024186804(10)66454820
• Combination Product (Y/N): N
• Initial Reporter Country: SN
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 12/02/2025

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: 00512008500
• Device Lot Number: 66454820
• 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: 09/23/2025
• Supplement Date Received by Manufacturer: 10/21/2025; 11/20/2025
• Initial Report FDA Received Date: 10/20/2025
• Supplement Report FDA Received Date: 10/23/2025; 12/02/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/25/2024
• 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