MAUDE Adverse Event Report: BIOMET MICROFIXATION 2.0MM SYSTEM TWIST DRILL WITH STOP J-NOTCH, 1.5X50MM 22MM; 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	12/14/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the drills fractured while drilling a hole for screw insertions during an osteotomy procedure for jaw deformity.Another drill was used to complete the procedure.There were no consequences or impact to the patient.It was reported that no further information is available.Attempts have been made and no further information has been provided.
Additional Manufacturer Narrative
Zimmer biomet complaint (b)(4).D10 ¿ medical products item# 01-9196, lot# 324112, 2.0mm system twist drill with stop j-notch, 1.5x50mm 22mm.G3: foreign: japan.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 report: 0001032347-2024-00046.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.H6: component code: mechanical (g04) ¿ drill a visual inspection was conducted on the returned drills.The drills show signs of attempted use including marking and scratching on the drill surface.Further investigation shows that the drills have fractured near where the fluted portion of the drills meet the drill base.A dimensional analysis was conducted on the two drills.In both cases both the drill tip and drill base were found to be within specification.The complaint is confirmed.A determination cannot be made as to what caused the drills to fracture.Review of the certs identified no deviations or anomalies during manufacturing.A definitive root cause cannot be determined.The reported event is confirmed.If any further information is found that 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 sections.
Event or Problem Description
No further event information is available at the time of this report.

• Brand Name: 2.0MM SYSTEM TWIST DRILL WITH STOP J-NOTCH, 1.5X50MM 22MM
• 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: 18627508
• Report Number: 0001032347-2024-00047
• Device Sequence Number: 12710499
• Product Code: HBE
• UDI-Device Identifier: 00841036016968
• UDI-Public: (01)00841036016968(11)181219(10)327489
• 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
• Report Date (Section B): 04/10/2024

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: 01-9196
• Device Lot Number: 327489
• 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: 01/08/2024
• Supplement Date Received by Manufacturer: 04/08/2024
• Initial Report FDA Received Date: 02/01/2024
• Supplement Report FDA Received Date: 04/10/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/19/2018
• 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