MAUDE Adverse Event Report: BIOMET MICROFIXATION TRAUMAONE SYSTEM 1Q 1.1MM DRILL WITH 5MM STOP; DRILLS, BURRS, TREPHINES & ACCESSORIES (SIMPLE, POWERED)

Model Number	N/A
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	10/16/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Zimmer biomet complaint (b)(4).The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.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.Sales rep.
Event or Problem Description
It was reported that a drill bit fractured while attempting to insert a screw into the patient's mandible.The procedure was completed with a back up driver and drill bit.No adverse events were reported as a result of this malfunction.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The complaint could not be verified.No product was returned and no functional tests or inspections could be performed.The distributor stated the drill bit fractured as soon as torque was applied to a screw during a mandible procedure; however, a drill bit is not intended to encounter a screw and further clarification was not provided by the distributor.A dhr review for this item could not be reviewed due to the lot being unknown.For all similar iq drills w/stop (part #72-20xx) in the previous one years (from the notification date) involving the drill fracturing, (b)(4).The most likely underlying cause could not 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.The following fields were updated: b4 date of this report, b5 describe event or problem, d10 device availability, g4 date received by manufacturer, g7 type of report, h2 follow up type, h3 device evaluated by manufacturer, h6 method code, h6 results code, h6 conclusions code, h10 additional narratives/data.
Event or Problem Description
This follow-up report is being submitted to relay additional information.

• Brand Name: TRAUMAONE SYSTEM 1Q 1.1MM DRILL WITH 5MM STOP
• Common Device Name: DRILLS, BURRS, TREPHINES & ACCESSORIES (SIMPLE, POWERED)
• Manufacturer (Section D): BIOMET MICROFIXATION; 1520 tradeport drive; jacksonville FL 32218
• MDR Report Key: 9330821
• Report Number: 0001032347-2019-00488
• Device Sequence Number: 11417029
• Product Code: HBE
• UDI-Device Identifier: 00841036163006
• UDI-Public: 00841036163006
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K062842
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/31/2020

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: 72-2030
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 10/16/2019
• Supplement Date Received by Manufacturer: 01/24/2020
• Initial Report FDA Received Date: 11/15/2019
• Supplement Report FDA Received Date: 01/31/2020
• 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