MAUDE Adverse Event Report: ZIMMER BIOMET, INC. PAT/FEM DRILL 6.4MMDIA; INSTRUMENT, KNEE

Catalog Number	00512005201
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/21/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).D4: attempts have been made to gather all product identification information, and no further information has been provided.G2- canada.H3- customer has indicated that the product will be returned to zimmer biomet for investigation.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Proposed annex g code: mechanical (g04) ¿ drill.
Event or Problem Description
It was reported that a metal pieces fractured off of a patella/femoral drill during surgery.While using the patella/femoral drill to drill patella holes through the drill guide, the metal of the drill was wearing off.The surgeon reported this and switched to another drill.No metal pieces contacted or remain in the patient.Attempts to obtain additional information have been made; however, no more information is available.
Additional Manufacturer Narrative
This report is being submitted to provide additional information.Updated: b4, b5, d2, d4, d9, g1, g3, g6, h1, h2, h4, and h11.
Event or Problem Description
No further event information available at the time of this report.
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, g3, g6, h2, h3, h6, h11.Visual evaluation of the returned drill confirmed the device exhibited signs of use (nicked/dinged) and striations were found on the collar.Dimensional analysis determined the device was conforming with specifications where measured.The device history records were reviewed and no discrepancies were identified.As the device had a field age of greater than seven (7) years and exhibits signs of repeated use, the root cause is attributed to wear and tear of the device from repeated use over time.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: PAT/FEM DRILL 6.4MMDIA
• 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: 22805597
• Report Number: 0001822565-2025-02934
• Device Sequence Number: 8950856
• Product Code: HTW
• UDI-Device Identifier: 00889024186583
• UDI-Public: (01)00889024186583(10)63849665
• 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): 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): 02/06/2026

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: 00512005201
• Device Lot Number: 63849665
• 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: 07/21/2025
• Supplement Date Received by Manufacturer: 08/18/2025; 02/05/2026
• Initial Report FDA Received Date: 08/14/2025
• Supplement Report FDA Received Date: 09/10/2025; 02/06/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/06/2017
• 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