MAUDE Adverse Event Report: BIOMET MICROFIXATION 2.0MM SYSTEM TWIST DRILL WITH J NOTCH 1.5MM X 50MM W/ 22MM STOP; DRILLS, BURRS, TREPHINES & ACCESSORIES (SIMPLE, POWERED)

Model Number	N/A
Medical Device Problem Codes	Fracture (1260); Material Twisted/Bent (2981)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/12/2020
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 one drill bit broke and another drill bit bent during a mandibular surgery.When the surgeon fixed the screw, the drill tip broke when it was fitted and rotated before use.The surgeon tried to use another drill, but it bent during surgery.The surgery was completed with a short drill tip.No adverse events have been reported as a result of the malfunction.
Event or Problem Description
No further event information available at the time of this report.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.Visual examination of the returned product confirmed that the drills had fractured and bent at the start of the fluted section.The drill identities were confirmed to be item# 01-9196, vendor lot# 345521 & item# 01-9196, vendor lot# 329508.The drill from vendor lot# 345521 was bent at the beginning of the fluted section.The drill from vendor lot# 329508 was fractured at the beginning of the fluted section.Review of the device history records identified no deviations or anomalies during manufacturing.The raw material certificates showed material is conforming to specification.A definitive root cause cannot 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.D4 ¿ the lot number (345521) etched on the drill is the vendor's lot number.Based on a review of inventory transactions and the customer's purchase history, there are five (5) possible zimmer biomet lots: 422580, 422560, 422590, 422610, or 422550.D10 ¿ medical products: 2.0mm system twist drill with j notch 1.5mm x 50mm w/ 22mm stop, part# 01-9196, lot# 322180 or 061750.

• Brand Name: 2.0MM SYSTEM TWIST DRILL WITH J NOTCH 1.5MM X 50MM W/ 22MM STOP
• Common Device Name: DRILLS, BURRS, TREPHINES & ACCESSORIES (SIMPLE, POWERED)
• Manufacturer (Section D): BIOMET MICROFIXATION; 1520 tradeport drive; jacksonville FL 32218
• MDR Report Key: 10917768
• Report Number: 0001032347-2020-00591
• Device Sequence Number: 545183
• Product Code: HBE
• UDI-Device Identifier: 00841036016968
• UDI-Public: 00841036016968
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K062842
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: distributor,foreign,health pr
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/09/2021

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: 01-9196
• Device Lot Number: SEE H10 NARRATIVE
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/30/2020
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 11/13/2020
• Supplement Date Received by Manufacturer: 06/04/2021
• Initial Report FDA Received Date: 11/30/2020
• Supplement Report FDA Received Date: 06/09/2021
• 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