MAUDE Adverse Event Report: BIOMET MICROFIXATION 1.5MM SYSTEM TWIST DRILL WITH J NOTCH 1.1 X 50MM, 9MM STOP; DRILLS, BURRS, TREPHINES & ACCESSORIES (SIMPLE, POWERED)

Model Number	N/A
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/10/2020
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 drill fractured during an open reduction and internal fixation procedure.The surgeon drilled a pilot hole while fixing a plate to the zygomatic frontal suture and found the drill was damaged after use.The procedure was completed using an alternate drill bit.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 drill had fractured at the start of the fluted section.The drill's identity was confirmed to be item# 01-7146, vendor lot# 155565.Review of the device history records identified no deviations or anomalies during manufacturing.The raw material certificate 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 (155565) 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 two (2) possible zimmer biomet lots: 250370 (mfg date: sep 2012), 099510 (mfg date: aug 2012).

• Brand Name: 1.5MM SYSTEM TWIST DRILL WITH J NOTCH 1.1 X 50MM, 9MM STOP
• Common Device Name: DRILLS, BURRS, TREPHINES & ACCESSORIES (SIMPLE, POWERED)
• Manufacturer (Section D): BIOMET MICROFIXATION; 1520 tradeport drive; jacksonville FL 32218
• MDR Report Key: 10896369
• Report Number: 0001032347-2020-00589
• Device Sequence Number: 3048672
• Product Code: HBE
• UDI-Device Identifier: 00841036013189
• UDI-Public: 00841036013189
• 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: 01-7146
• 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: 11/11/2020
• Supplement Date Received by Manufacturer: 06/04/2021
• Initial Report FDA Received Date: 11/24/2020
• 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