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

Catalog Number	31-323230
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	01/21/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Mechanical (g04) - drill.G2: foreign - event occurred in canada.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.
Event or Problem Description
It was reported that during a primary hip procedure, two drill bits fractured while drilling for acetabular screws in a multihole acetabular shell, and when the second fractured, the tip remained in the patient.The patient had a retained drill tip.Attempts have been made and no further information has been provided.
Event or Problem Description
No further information at the time of this report.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The following sections were {update/corrected}.Updated: d9; g3; h2; h3; h6.Visual examination of the returned product identified both devices are fractured near the base of the flutes.The fractured flute end was returned for lot 67539999, the fractured flute end was not returned for lot 67437085.There are multiple nicks and cracks in the fluted region of the device returned for lot 67437085.The flutes visually appear bent on the device returned for lot 67437085.No other damage was noted during visual evaluation.These devices both have an approximate field age of 4-5 months.Fracture surfaces on both the devices (lot# 67437085 & lot# 67539999) exhibit faint river lines and hinge artifacts on opposite edges suggesting that the device possibly fractured due to reverse bending overload.Review of the device history records identified no deviations or anomalies during manufacturing.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 will be filed accordingly.Zimmer biomet will continue to monitor for trends.

• Brand Name: 3.2MMX30MM RNGLC+ ACET DRL BIT
• 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: 24247462
• Report Number: 0001825034-2026-00281
• Device Sequence Number: 18556106
• Product Code: HTW
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/04/2026

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: 31-323230
• Device Lot Number: 67437085
• 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: 01/21/2026
• Supplement Date Received by Manufacturer: 06/04/2026
• Initial Report FDA Received Date: 02/03/2026
• Supplement Report FDA Received Date: 06/05/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/07/2025
• 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: Reuse
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown