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

Catalog Number	00512008500
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/03/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4) g2: event occurred in canada.H6: mechanical (g04) - drill.The 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.
Event or Problem Description
It was reported that the drill fractured during surgery.The surgical technique was utilized.There was no impact to the patient.No foreign bodies were retained in the patient.There was no surgical delay.The surgery was completed with a second device.Attempts have been made and all available information has been provided.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The following sections were updated: b4; b5; d2; d4; d9; g1; g3; g6; h1; h2; h4 the investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.
Event or Problem Description
No further event information available at the time of this report.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The following sections were updated.B4; b5; d2; g1; g3; g6; h1; h2; h3; h6.Attempts have been made to gather all product identification information and no further information has been provided.The event is confirmed.Visual examination of the provided picture identified a broken / fractured kn nexgen tibial bone screw drill 3.2mm.The device shows signs of use such as scratches and oxidation.The device history record was unable to be performed as the lot number of the device involved in the event is unknown.Medical records were not provided.A definitive root cause cannot be determined.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 available at the time of this report.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The following sections were updated: b4; b5; d2; d4; g1; g3; g6; h1; h2; h3; h6.Visual inspection of the returned device confirms that the device has fractured in two pieces.Shows signs of use and wear and tear and the connection feature of the device has some scratches and gouges.The flutes of the drill bit are also damaged with some gouges was well.The outer diameter of the flutes is conforming to the print specification.The device history record was reviewed and no discrepancies relevant to the reported event were found.The root cause can be contributed to normal wear and tear of device.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 available at the time of this report.

• Brand Name: MG II BONE SCREW DRILL 3.2MMDIA
• Common Device Name: INSTRUMENT, KNEE
• 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: 23586981
• Report Number: 0001822565-2025-04211
• Device Sequence Number: 15758819
• Product Code: HTW
• UDI-Device Identifier: 00889024186804
• UDI-Public: (01)00889024186804(10)63871705
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: EXEMPT
• 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,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 04/01/2026

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: 00512008500
• Device Lot Number: 63871705
• 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: 11/03/2025
• Supplement Date Received by Manufacturer: 12/03/2025; 12/19/2025; 03/31/2026
• Initial Report FDA Received Date: 11/18/2025
• Supplement Report FDA Received Date: 12/26/2025; 12/29/2025; 04/01/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/25/2018
• 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: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown