MAUDE Adverse Event Report: BIOMET MICROFIXATION 2.0MM SYSTEM TWIST DRILL WITH J NOTCH 1.5MM X 105MM W/ 22MM STOP; DRILLS, BURRS, TREPHINES & ACCESSORIES (SIMPLE, POWERED)

Model Number	N/A
Medical Device Problem Codes	Flaked (1246); Fracture (1260)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	06/18/2020
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.Multiple mdr reports were filed for this event, please see associated reports: 0001032347-2020-00285.Medical products: 2.0mm system twist drill with j notch 1.5mm x 105mm w/ 22mm stop, part# 01-9198, lot# ni.2.0mm system twist drill contra 1.5mm x 30.5mm w/ 15.5mm stop, part# 01-9181, lot# ni.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 the drill bit fractured while fixing the plate with a trocar.The drill guide was utilized.When using the contra drill bit, the paint peeled off.Paint was removed from the patient with gauze, but some of the paint may remain in the patient¿s body.No additional patient consequences have been reported.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The following fields were updated: b4 date of this report b5 describe event or problem d4 serial number d4 lot number - based on a review of inventory transactions and this customer's purchase history, there are five possible lots: 008430 008420 008390 008450 008280 g4 date received by manufacturer g7 type of report h2 if follow-up, what type h4 device manufacturer date h10 additional narratives/data.
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.The device was returned for investigation.Visual evaluation of the drill showed that it was fractured near the neck, at the beginning of the fluted section of the drill.The cert was reviewed and there were no non-conformances found.There are no indications of manufacturing defects.This is the only complaint for this item# 01-9198, vendor lot# 333925.The most likely underlying cause of the drill fracturing is excessive force was applied, beyond what the instrument was designed to encounter.It is possible that the drill was used over its maximum recommended speed, it was used to drill into high density bone, excessive normal force was applied during drilling, or off-axis forces were applied during drilling.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: 2.0MM SYSTEM TWIST DRILL WITH J NOTCH 1.5MM X 105MM 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: 10209522
• Report Number: 0001032347-2020-00284
• Device Sequence Number: 2404612
• Product Code: HBE
• UDI-Device Identifier: 00841036016982
• UDI-Public: 00841036016982
• 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): 10/28/2020

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: 01-9198
• Device Lot Number: SEE H10 NARRATIVE
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/09/2020
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 06/19/2020
• Supplement Date Received by Manufacturer: 08/18/2020; 10/27/2020
• Initial Report FDA Received Date: 06/29/2020
• Supplement Report FDA Received Date: 08/24/2020; 10/28/2020
• 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
• Concomitant Medical Products and Therapy/Usage Dates: SEE H10 NARRATIVE
• Outcome Attributed to Adverse Event: Required Intervention