MAUDE Adverse Event Report: BIOMET MICROFIXATION DRILL 2.0X70 12STP J-NTCH; 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	01/24/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Zimmer biomet complaint (b)(4).Report source: foreign source: germany.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.
Event or Problem Description
It is reported that during a procedure that the drill fractured during pre-drilling for mandibular screws.The item was new and had been used approximately 3 to 5 times for the other holes in the patient's mandibular area.Attempts have been made and additional information on the reported event is unavailable at this time.
Event or Problem Description
No further event information is available at the time of this report.
Additional Manufacturer Narrative
This report is being submitted to update additional information in section b4, b5, d4, g3, g6, h2, and h10.
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.H6: component code: suggested component code- mechanical (g04) ¿ drill.No product was returned.Inspection of the customer provided picture clearly shows that the upper portion of the notched end of the drill bit has fractured.The drill tip is still intact.The complaint is confirmed.A determination cannot be made as to what caused the notched portion of the drill to fracture.A lot number cannot be determined off of the customer provided picture.Lot identification is necessary for review of device history records, lot identification was not provided.A definitive root cause cannot be determined.The reported event is confirmed, based on the provided photo.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.

• Brand Name: DRILL 2.0X70 12STP J-NTCH
• 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: 16310961
• Report Number: 0001032347-2023-00048
• Device Sequence Number: 7048730
• Product Code: HBE
• UDI-Device Identifier: 00841036036669
• UDI-Public: (01)00841036036669
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/27/2023

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: 24-6614
• Was Device Available for Evaluation?: No
• 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: 01/24/2023
• Supplement Date Received by Manufacturer: 02/23/2023; 06/21/2023
• Initial Report FDA Received Date: 02/07/2023
• Supplement Report FDA Received Date: 02/24/2023; 06/28/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): No
• 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
• Patient Sex: Unknown