MAUDE Adverse Event Report: BIOMET MICROFIXATION 2.0MM SYSTEM TWIST DRILL WITH J NOTCH 1.5 X 50MM, 10MM STOP; DRILLS, BURRS, TREPHINES & ACCESSORIES (SIMPLE, POWERED)

Model Number	N/A
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/25/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Zimmer biomet complaint : (b)(4).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.The user facility is foreign, therefore, a facility medwatch report will not be available.Foreign source: (b)(6).
Event or Problem Description
It was reported a drill bit fractured during use.The procedure was completed using an alternate drill bit.No adverse events have been reported as a result of the malfunction.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The tw drill 1.5x50mm 10mmstp w/nt (item# 01-9195, lot# unk) was returned for investigation.Visual examination of the returned product confirmed the reported item number.This twist drill did not have a lot number etching.Visual examination of the returned product confirmed the reported item number.Lot identification is necessary for review of device history records, lot identification was not provided.The drill was confirmed to be fractured near the start of the fluted section.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.
Event or Problem Description
No further event information available at the time of this report.

• Brand Name: 2.0MM SYSTEM TWIST DRILL WITH J NOTCH 1.5 X 50MM, 10MM STOP
• Common Device Name: DRILLS, BURRS, TREPHINES & ACCESSORIES (SIMPLE, POWERED)
• Manufacturer (Section D): BIOMET MICROFIXATION; 1520 tradeport drive; jacksonville FL 32218
• MDR Report Key: 11051113
• Report Number: 0001032347-2020-00623
• Device Sequence Number: 2636216
• Product Code: HBE
• UDI-Device Identifier: 00841036016951
• UDI-Public: 00841036016951
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K062842
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: distributor,foreign,health pr
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/15/2021

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 Model Number: N/A
• Device Catalogue Number: 01-9195
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/16/2020
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 11/30/2020
• Supplement Date Received by Manufacturer: 09/14/2021
• Initial Report FDA Received Date: 12/21/2020
• Supplement Report FDA Received Date: 09/15/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: N/A
• Patient Sequence Number: 1