MAUDE Adverse Event Report: BIOMET MICROFIXATION 2.0MM SYSTEM TWIST DRILL WITH J NOTCH 1.5 X 50MM, 7MM STOP; DRILLS, BURRS, TREPHINES & ACCESSORIES (SIMPLE, POWERED)

Model Number	N/A
Medical Device Problem Code	Flaked (1246)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	03/25/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Zimmer biomet complaint (b)(4).Customer has indicated that the product is in process of being returned to zimmer biomet for investigation.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.Report source - (b)(6).
Event or Problem Description
It was reported the paint band on the drill bit peeled off and fell in the patient while drilling a pilot hole in the patient's mandible.The paint was removed from the patient with forceps.No adverse events have been reported as a result of the malfunction.
Event or Problem Description
This follow-up report is being submitted to relay additional information.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.D4 based on a review of the inventory transaction history and the customer's purchase history, there are two (2) possible lots: 893670, 893430.The complaint is confirmed.A visual inspection was performed on the drill.The blue paint that wraps around the tip of the drill is missing and the groove in which the paint sits is clean.The tip of the drill was also 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 paint breaking off of the drill for 01-9193 serial number (b)(6).The most likely underlying cause of the complaint is the drill experienced stresses in excess of what it was designed to encounter.The ifu for this product states the drill should not be reused, recleaned, or resterilized.It is possible that being reused, recleaned, and resterilized contributed to the peeling of the paint.Fractures at this point of the drill are typical of excessive force fractures.Excessive force combined with being reused multiple times could have resulted in the drill fracturing.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.

• Brand Name: 2.0MM SYSTEM TWIST DRILL WITH J NOTCH 1.5 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: 9949757
• Report Number: 0001032347-2020-00213
• Device Sequence Number: 19647760
• Product Code: HBE
• UDI-Device Identifier: 00841036016937
• UDI-Public: 00841036016937
• 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: foreign,health professional,u
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/11/2020

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: 01-9193
• Device Lot Number: SEE H10 NARRATIVE
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/03/2020
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 03/31/2020
• Supplement Date Received by Manufacturer: 09/08/2020
• Initial Report FDA Received Date: 04/10/2020
• Supplement Report FDA Received Date: 09/11/2020
• 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