MAUDE Adverse Event Report: BIOMET MICROFIXATION TRAUMAONE SYSTEM DRILL, 1.6X115MM 26MM 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	11/19/2019
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.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 two drill bits fractured while drilling into the lower jaw using a trocar.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 complaint is confirmed.The drills were returned for evaluation.On visual inspection, the drills were noted to have a transverse fractures through the flutes near the neck.The dhr was reviewed and there were no non-conformances found.There are no indications of manufacturing defects.For this part (01-7144) and the previous one year (from the notification date) regarding the drill fracturing, there is a complaint rate of 0.24%, which is no greater than the occurrence listed in the application fmea.This is the only complaint in regards to the drill fracturing for 46-1007 lot 327137.The most likely underlying cause of the complaint is the drills 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.
Event or Problem Description
This follow-up report is being submitted to relay additional information.

• Brand Name: TRAUMAONE SYSTEM DRILL, 1.6X115MM 26MM STOP
• Common Device Name: DRILLS, BURRS, TREPHINES & ACCESSORIES (SIMPLE, POWERED)
• Manufacturer (Section D): BIOMET MICROFIXATION; 1520 tradeport drive; jacksonville FL 32218
• MDR Report Key: 9537003
• Report Number: 0001032347-2019-00590
• Device Sequence Number: 19457852
• Product Code: HBE
• UDI-Device Identifier: 00841036137427
• UDI-Public: 00841036137427
• 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): 03/27/2020

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: 46-1007
• Device Lot Number: 327137
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/27/2020
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 12/03/2019
• Supplement Date Received by Manufacturer: 03/20/2020
• Initial Report FDA Received Date: 12/31/2019
• Supplement Report FDA Received Date: 03/27/2020
• 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