MAUDE Adverse Event Report: ZIMMER BIOMET, INC. VANGUARD SHORTQUICK-RELEASE DRILL; BIT, DRILL

Catalog Number	32-486259
Medical Device Problem Codes	Fracture (1260); Separation Failure (2547)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/15/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).G2: foreign: japan.H6: proposed component code: mechanical (g04) - drill.The product has been received by zimmer biomet and the investigation is in process.Upon completion of the investigation, a follow-up mdr will be submitted.
Event or Problem Description
It was reported that during a total knee procedure, the quick release drill fractured.There was no patient impact and no adverse events have been reported as a result of the malfunction.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 were updated: b4; b5; d4; g3; h2; h3; h4; h6; h10; h11.Visual examination of the returned drill identified signs of use (scuffs) and confirmed the reported event that a drill pin had broken inside the drill.A piece of the fractured drill pin remained lodged inside the drill, and not all pieces of the fractured pin were returned.Dimensional analysis of the drill determined that the product, where measured, was conforming to print specifications.The device history record was reviewed and no discrepancies relevant to the reported event were found.Investigation results concluded that the root cause of the reported event has been identified as not device related as the returned drill meets specification and only exhibits scuffs from use.Complaint sample was evaluated and the reported event was confirmed.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.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The following sections have been updated: b4; b5; d10; g3; h2; h3; h6; h11.D10: medical product: unknown drill pin: catalog#ni, lot#ni.The product has been received by zimmer biomet and the investigation is in process.Upon completion of the investigation, a follow-up mdr will be submitted.
Event or Problem Description
It was reported that during a total knee procedure, the quick release drill fractured.A fractured fragment of a drill pin remains lodged in the quick release drill.There was no patient impact and no adverse events have been reported as a result of the malfunction.It was reported that all available information has been provided.

• Brand Name: VANGUARD SHORTQUICK-RELEASE DRILL
• Common Device Name: BIT, DRILL
• Manufacturer (Section D): ZIMMER BIOMET, INC.; 56 e. bell drive; p.o. box 587; warsaw IN 46581
• Manufacturer (Section G): ZIMMER BIOMET, INC.; 56 e. bell drive; p.o. box 587; warsaw IN 46581
• Manufacturer Contact: jennifer rapsavage ; 56 e. bell dr.; warsaw, IN 46582 ; 5745260384
• MDR Report Key: 23179540
• Report Number: 0001825034-2025-03043
• Device Sequence Number: 21097999
• Product Code: HTW
• UDI-Device Identifier: 00887868494758
• UDI-Public: (01)00887868494758(11)220909(10)ZB7318545
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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): 01/09/2026

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: 32-486259
• Device Lot Number: ZB7318545
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 09/25/2025
• 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: 09/03/2025
• Supplement Date Received by Manufacturer: 12/03/2025; 01/06/2026
• Initial Report FDA Received Date: 09/30/2025
• Supplement Report FDA Received Date: 12/08/2025; 01/09/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/09/2022
• 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
• Concomitant Medical Products and Therapy/Usage Dates: SEE H11 NARRATIVE.
• Patient Sex: Unknown