MAUDE Adverse Event Report: BIOMET MICROFIXATION TOTAL MANDIBULAR SYSTEM 1.8X50MM DRILL, 26MM STOP; DRILLS, BURRS, TREPHINES & ACCESSORIES (SIMPLE, POWERED)

Model Number	N/A
Medical Device Problem Codes	Fracture (1260); Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	05/28/2020
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.Foreign report source: (b)(6).
Event or Problem Description
It was reported that one drill bit fractured and one drill bit bent during a procedure.No adverse events were reported as a result of the malfunction.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The following fields were updated: d4 lot number - based on a review of inventory transactions and this customer's purchase history, there are seven (7) possible lot numbers: 895130, 895240, 229460, 418120, 418100, 895210, and 895220.
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.The complaint is confirmed.A visual inspection was carried out on the two drills.One of the two drills was bent at a 45 degree angle while the other drill was fractured into two pieces.The raw material 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/ bending of 24-2050 lot 321017.The most likely underlying cause is excessive force was applied beyond what the product is designed to encounter.It is possible off axis drilling occurred.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: TOTAL MANDIBULAR SYSTEM 1.8X50MM DRILL, 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: 10120179
• Report Number: 0001032347-2020-00260
• Device Sequence Number: 16606427
• Product Code: HBE
• UDI-Device Identifier: 00841036059279
• UDI-Public: 00841036059279
• 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,Followup
• Report Date (Section B): 09/22/2020

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: 24-2050
• Device Lot Number: SEE H10 NARRATIVE
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/17/2020
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 06/01/2020
• Supplement Date Received by Manufacturer: 08/19/2020; 09/22/2020
• Initial Report FDA Received Date: 06/04/2020
• Supplement Report FDA Received Date: 08/24/2020; 09/22/2020
• 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