MAUDE Adverse Event Report: ZIMMER BIOMET, INC. 3.2MMX30MM RNGLC+ ACET DRL BIT; ORTHOPEDIC MANUAL SURGICAL INSTRUMENT, BIT, DRILL

Catalog Number	31-323230
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/21/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a disposable drill broke while in use during surgery.No adverse events have been reported as a result of the malfunction.Attempts have been made and no further information has been provided.
Additional Manufacturer Narrative
(b)(4).H6: proposed component code: mechanical (g04) - drill.The device will not be returned for analysis; however, an investigation of the reported event is in progress.Once the investigation is completed, a supplemental medwatch 3500a will be submitted.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The following sections were {update/corrected}.Updated: b5, e1 surgeon name.
Event or Problem Description
All pieces that fell into the patient were retrieved.No fragments remained inside the patient.The surgery was completed with a second device.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The following sections were updated: g3; h3; h6.The reported event was confirmed by review of pictures.Visual examination of the provided pictures identified the broken drill bit with biodebris.The drill bit has fractured into two pieces, and the fracture point is near the top of the flute and shaft junction.No other fragments could be seen in the photo provided.No product was returned; further visual and dimensional evaluations could not be performed.The device history record was reviewed and no discrepancies relevant to the reported event were found.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 information.

• Brand Name: 3.2MMX30MM RNGLC+ ACET DRL BIT
• Common Device Name: ORTHOPEDIC MANUAL SURGICAL INSTRUMENT, 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: 23921265
• Report Number: 0001825034-2025-04232
• Device Sequence Number: 15659605
• Product Code: HTW
• UDI-Device Identifier: 00887868478703
• UDI-Public: (01)00887868478703(17)350823(10)67446521
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• 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: Consumer,Health Professional
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 05/19/2026

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: 31-323230
• Device Lot Number: 67446521
• 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: 12/29/2025
• Supplement Date Received by Manufacturer: 12/30/2025; 05/19/2026
• Initial Report FDA Received Date: 12/30/2025
• Supplement Report FDA Received Date: 12/30/2025; 06/08/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/23/2025
• 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
• Patient Age: 72 YR
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic
• Patient Race: White