MAUDE Adverse Event Report: BIOMET MICROFIXATION 2.0MM SYSTEM TWIST DRILL WITH J NOTCH

Model Number	N/A
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/20/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Zimmer biomet complaint (b)(4).D10: medical product - zimmer biomet 2.0mm system twist drill with j notch catalog #: 01-9196 lot #: 345521; zimmer biomet 2.0mm system twist drill with j notch catalog #: 01-9196 lot #: 329508 g3: foreign - event occurred in 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 reports: 0001032347-2023-00413.
Event or Problem Description
It was reported that the drill fractured during an intermaxillary fixation procedure.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.
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: suggested component code- mechanical (g04) ¿ drill.A visual inspection was conducted on the returned drills.The drills both show signs of attempted use including marking/ scratching on the drill surface.Both drills have clearly fractured near where the fluted portion of the drill meets the drill base.In both cases 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 supplier dhr review was not conducted as material cert confirms that the material and hardness of the instrument meet specification requested as certs show.A review of end level device history records was not performed as it is package and label related only and reported event is not associated with a packaging or labeling related issue.A definitive root cause cannot be determined.The reported event is confirmed, based on product return.If any further information is found which would change or alter any conclusions or information, a supplemental will be filed accordingly.Zimmer biomet will continue to monitor for trends.

• Brand Name: 2.0MM SYSTEM TWIST DRILL WITH J NOTCH
• Common Device Name: DRILL
• 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: 18084769
• Report Number: 0001032347-2023-00414
• Device Sequence Number: 20480739
• Product Code: HBE
• UDI-Device Identifier: 00841036016968
• UDI-Public: (01)00841036016968(10)329508
• 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,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/30/2023

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: 01-9196
• Device Lot Number: 329508
• 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: 10/11/2023
• Supplement Date Received by Manufacturer: 11/29/2023
• Initial Report FDA Received Date: 11/07/2023
• Supplement Report FDA Received Date: 11/30/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/22/2019
• 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: Unknown
• 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