MAUDE Adverse Event Report: BIOMET MICROFIXATION "1.0MM" SYSTEM TWIST DRILL TW 7X50MM 3MMSTOP W/NTC; 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	09/01/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It is reported that the drill fractured during a procedure.The surgeon was aware the drill was experiencing tension and fractured.Attempts have been made and additional information on the reported event is unavailable at this time.
Additional Manufacturer Narrative
Zimmer biomet complaint (b)(4).G2: foreign source: 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.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.H6: suggested component code- mechanical (g04) ¿ drill.No product was returned.A visual inspection was conducted on the customer-provided pictures.The pictures show signs of attempted use including marking and scratching on the drill surface.The customer-provided picture shows that the drill has fractured where the drill base meets the fluted portion of the drill tip.The complaint is confirmed.A determination cannot be made as to what caused the drill tip to fracture.Review of the device history record(s) identified no deviations or anomalies during manufacturing.A definitive root cause cannot be determined.The reported event is confirmed, based on provided photos.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.
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 drill.The drill shows signs of attempted use including marking and scratching on the drill surface.The drill has fractured near where the fluted portion of the drill meets the drill base.The fracture tip was not returned.A dimensional analysis was conducted on the returned product utilizing caliper.The product was found to be within specification.The complaint is confirmed.A determination cannot be made as to what caused the drill to fracture.A fracture analysis was not performed as product is single use and the material cert confirms the material and hardness of the drill meet specification.The root cause of the reported issue is attributed to a user error.It was reported that the surgeon was aware that the drill was under tension and it broke.Twist drills are not meant to experience tensile forces.The reported event is confirmed, based on product return.
Event or Problem Description
No further event information is available at the time of this report.

• Brand Name: "1.0MM" SYSTEM TWIST DRILL TW 7X50MM 3MMSTOP W/NTC
• 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: 17867776
• Report Number: 0001032347-2023-00363
• Device Sequence Number: 7028797
• Product Code: HBE
• UDI-Device Identifier: 00841036014209
• UDI-Public: (01)00841036014209(10)361320
• 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): 05/20/2024

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: 01-7423
• Device Lot Number: 361320
• 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: 09/08/2023
• Supplement Date Received by Manufacturer: 10/19/2023; 05/14/2024
• Initial Report FDA Received Date: 10/04/2023
• Supplement Report FDA Received Date: 10/27/2023; 05/20/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/04/2020
• 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
• Patient Sex: Unknown