MAUDE Adverse Event Report: BIOMET MICROFIXATION 1.5MM SYSTEM TWIST DRILL WITH J NOTCH 1.1 X 50MM, 7MM 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	10/13/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Zimmer biomet (b)(4).The complaint is confirmed.On visual inspection, the drill was noted to have a transverse fracture through the flutes near the neck.The cert was reviewed and there were no non-conformances found.There are no indications of manufacturing defects.This is the only complaint in regards to the drill fracturing for 01-7144 vendor lot 249085.The most likely underlying cause of the complaint is the drill experienced force in excess of what it was designed to encounter; fractures at this point of the drill are typical of excessive force fractures.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.Lot number - the lot number (249085) etched on the drill is the vendor's lot.Based on a review of inventory transactions and this customer's purchase history, there are five (5) possible zimmer biomet lots: 131210, 002950, 889980, 889970, 580800.Medical products: unknown 1.5l plate, part# ni, lot# ni.The user facility is foreign; therefore, a facility medwatch report will not be available.Report source ¿ (b)(6).
Event or Problem Description
It was reported the drill tip fractured during a procedure.The maxillary anterior wall was secured with a 1.5l plate and the drill broke during use.The nurse noted the fractured piece could not be located in the body and the doctor took an x-ray which did not show the fractured piece.Later the fractured piece of the drill was located in the suction effluent bottle and the procedure was resumed.The surgery was completed with an alternate drill.It was reported that no further information is available.

• Brand Name: 1.5MM SYSTEM TWIST DRILL WITH J NOTCH 1.1 X 50MM, 7MM STOP
• Common Device Name: DRILLS, BURRS, TREPHINES & ACCESSORIES (SIMPLE, POWERED)
• Manufacturer (Section D): BIOMET MICROFIXATION; 1520 tradeport drive; jacksonville FL 32218
• MDR Report Key: 10762730
• Report Number: 0001032347-2020-00536
• Device Sequence Number: 11024922
• Product Code: HBE
• UDI-Device Identifier: 00841036013165
• UDI-Public: 00841036013165
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K062842
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,foreign,health pr
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 10/30/2020

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: 01-7144
• Device Lot Number: SEE H10 NARRATIVE
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/20/2020
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/15/2020
• Initial Report FDA Received Date: 10/30/2020
• 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