MAUDE Adverse Event Report: BIOMET MICROFIXATION 2.0 MM SYSTEM CONTRA DRILL 1.5X15.5MM STP; DRILLS, BURRS, TREPHINES & ACCESSORIES (SIMPLE, POWERED)

Model Number	N/A
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/30/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It is reported that the drill tip was fractured when used on the mandible during a procedure.There was a delay during the procedure of approximately ten minutes to change out the drill.
Additional Manufacturer Narrative
Zimmer biomet complaint (b)(4).Foreign source: japan.Concomitant medical products item #01-9181 , lot# 319225, 2.0 mm system contra drill 1.5x15.5mm stp.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: 0001032347-2023-00098.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.H6: component code: mechanical (g04) - drill.No product was returned.A visual inspection was conducted on the customer provided pictures.Both drills show signs of use including marking/ scratching on the drill surfaces.In both cases the drills have fractured.Review of the device history record(s) identified no deviations or anomalies during manufacturing.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.
Event or Problem Description
No further event information is available at the time of this report.
Event or Problem Description
No further event information is available at the time of this report.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.A visual inspection was conducted on the returned drills.Both drills show signs of attempted uses including marking on both drill bodies.Further investigation showed that both drills fractured where the fluted portion of the drill meets the drill body.For both drills the complaint is confirmed.A determination cannot be made as to what caused the drills to fracture.Review of the device history records identified no deviations or anomalies during manufacturing related to the reported event.A definitive root cause cannot be determined.The reported event is confirmed, based on product return.This report is being submitted to update additional information in sections b4, b5, d9, g3, g6, h2, h3, h6 and h10.

• Brand Name: 2.0 MM SYSTEM CONTRA DRILL 1.5X15.5MM STP
• Common Device Name: DRILLS, BURRS, TREPHINES & ACCESSORIES (SIMPLE, POWERED)
• Manufacturer (Section D): BIOMET MICROFIXATION; 1520 tradeport drive; jacksonville FL 32218
• Manufacturer (Section G): BIOMET MICROFIXATION; 1520 tradeport drive; jacksonville FL 32218
• Manufacturer Contact: jennifer rapsavage ; 56 e. bell dr.; warsaw, IN 46582 ; 5745260384
• MDR Report Key: 16627384
• Report Number: 0001032347-2023-00097
• Device Sequence Number: 19947839
• Product Code: HBE
• UDI-Device Identifier: 00841036016890
• UDI-Public: (01)00841036016890(10)321206
• 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: Foreign,Health Professional,Company Representative,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/27/2023

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: 01-9181
• Device Lot Number: 321206
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/01/2023
• Supplement Date Received by Manufacturer: 04/26/2023; 10/23/2023
• Initial Report FDA Received Date: 03/28/2023
• Supplement Report FDA Received Date: 04/28/2023; 10/27/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/01/2018
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• 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
• Patient Sex: Unknown