MAUDE Adverse Event Report: BIOMET MICROFIXATION 1.5MM SYSTEM TWIST DRILL WITH J NOTCH 1.1 X 50MM, 7MM 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	11/12/2020
Type of Reportable Event	Serious Injury
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.Serial number: customer provided the vendor lot number / serial number (b)(4).However, this number appears to be invalid as there is no record of this vendor lot number.The user facility is foreign; therefore, a facility medwatch report will not be available.Report source: (b)(4).
Event or Problem Description
It was reported a drill bit fractured during an open reduction and internal fixation of a zygomatic fracture resulting in a one (1) hour delay.The drill tip broke when the surgeon fixed the infraorbital margin.The surgery was delayed for about an hour to find and remove the broken drill tip.The surgeon scraped the surrounding bone, took an x-ray, and removed the broken drill tip while locating the debris.It was reported that no further information is available.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The tw drill 1.1x50mm 7mmstop w/nt (item# 01-7144, lot# 210575) was returned for investigation.It was determined that the 210575 etched on the body of these drills is the vendor's lot.Based on a review of inventory transactions and the customer's purchase history, there are 3 possible zimmer biomet lots: 210510, 210520, or 930610.Visual examination of the returned drill confirmed the product's identity.It was also confirmed that the drill was fractured, near the neck at the start of the fluted section.Review of the device history records identified no deviations or anomalies during manufacturing.The supplier dhr was not requested because the raw material certificate showed material is conforming to specification, including the material hardness.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.This report is being submitted to update additional information in section d4, d9, h2, h3, h6 and h10.D4 ¿ there are three (3) possible lot numbers lot# 210510, udi# (b)(4), manufacture date: 16 feb 2015 lot# 210520, udi# (b)(4) , manufacture date: 17 feb 2015 lot# 930610, udi# ((b)(4) , manufacture date: 20 jan 2020.
Event or Problem Description
No further event information available at the time of this report.

• Brand Name: 1.5MM SYSTEM TWIST DRILL WITH J NOTCH 1.1 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: 10917837
• Report Number: 0001032347-2020-00592
• Device Sequence Number: 545184
• Product Code: HBE
• UDI-Device Identifier: 00841036013165
• UDI-Public: 00841036013165
• 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): 06/25/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 01-7144
• Device Lot Number: SEE H10 NARRATIVE
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/25/2020
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 11/13/2020
• Supplement Date Received by Manufacturer: 06/25/2021
• Initial Report FDA Received Date: 11/30/2020
• Supplement Report FDA Received Date: 06/25/2021
• 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
• Outcome Attributed to Adverse Event: Required Intervention