MAUDE Adverse Event Report: ZIMMER BIOMET, INC. LAG SCREW DRILL; FLUTED SURGICAL DRILL BIT, REUSABLE

Catalog Number	211201303
Medical Device Problem Codes	Fracture (1260); Difficult to Insert (1316)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/07/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a procedure, the lag screw drill got caught on the affixus rod and the tip of the lag drill broke off during drilling for the lag screw.The broken piece was immediately removed with the guide wire and disposed of in the sharps container.No patient consequences were reported as a result of the event.Attempts have been made and no further information has been provided.
Additional Manufacturer Narrative
(b)(4).D10: item# unk affixus rod; lot# unknown.H6: proposed component code - mechanical (g04) - drill.Product has been received by zimmer biomet and the investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.If any further information which would change or alter any conclusions or information, a supplemental report will be filed accordingly.Zimmer biomet will continue to monitor for trends.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The following sections were updated/corrected: b4; b5; d2; g1; g3; g6; h1; h2; h3; h6 d10: item# unk nail; lot# unknown.Item# unk targeting guide; lot# unknown.Item# unk affixus rod; lot# unknown.Visual examination of the returned drill product identified signs of use with some wear and tear on the proximal end of the reamer as well as some damage to the connecting feature.There is also some galling on the shaft of the reamer and damage to the cutting flutes.The reamer has fractured at the distal end, and the broken piece was not returned with the rest of the device.Shaft diameter was measured and conforming to specifications.Medical records were not provided.Review of the device history record(s) identified no deviations or anomalies during manufacturing.A definitive root cause cannot be determined.The event was confirmed.If any further information 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: LAG SCREW DRILL
• Common Device Name: FLUTED SURGICAL DRILL BIT, REUSABLE
• 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: 22357116
• Report Number: 0001825034-2025-01910
• Device Sequence Number: 8052815
• Product Code: HWD
• UDI-Device Identifier: 00887868023224
• UDI-Public: (01)00887868023224(11)120601(10)SO2000511
• Combination Product (Y/N): N
• Initial Reporter State: ME
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/12/2025

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: 211201303
• Device Lot Number: SO2000511
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/24/2025
• 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: 06/07/2025
• Supplement Date Received by Manufacturer: 12/12/2025
• Initial Report FDA Received Date: 06/30/2025
• Supplement Report FDA Received Date: 12/15/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/01/2012
• 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
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: NI
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SEE NARRATIVE IN H11.
• Patient Sex: Unknown