MAUDE Adverse Event Report: BIOMET MICROFIXATION 1.5MM SYSTEM TW DRILL 1.1X50MM 7MMSTOP W/NT; DRILLS, BURRS, TREPHINES & ACCESSORIES (SIMPLE, POWERED)

Model Number	N/A
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	04/14/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during a procedure that the tip of the drill fractured off when drilling for screw insertion.The tip remains in the patient.The procedure was completed with a different drill.The surgeon will monitor the patient.
Additional Manufacturer Narrative
Zimmer biomet complaint (b)(4).G2: 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.
Event or Problem Description
No further event information available at the time of this report.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.H6: proposed component code - mechanical (g04) ¿ drill.No product was returned.A visual inspection was conducted on the customer provided pictures.The pictures clearly show that the drill has fractured where the drill body meets the fluted portion of the drill tip.Medical records were not provided.Dhr was reviewed and no discrepancies relevant to the reported event were found.A definitive root cause cannot be determined.If any further information which would change or alter any conclusions or information, a supplemental report will be filed accordingly.Zimmer biomet will continue to monitor for trends.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The following sections were corrected: g3 ¿ the awareness date for this event was incorrectly reported initially.The following sections were updated: b4, b5, d9, g3, g6, h2, h11.Product has been received by zimmer biomet and the investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.
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 driver surface.The drill has fractured near where the fluted portion of the drill meets the drill base.A dimensional analysis was conducted on the portion of the fractured drill that was returned and found within specification.The fractured drill tip was not returned.A definitive root cause cannot be determined.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.
Event or Problem Description
No further event information available at the time of this report.

• Brand Name: 1.5MM SYSTEM TW DRILL 1.1X50MM 7MMSTOP W/NT
• 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: 17121267
• Report Number: 0001032347-2023-00230
• Device Sequence Number: 6649720
• Product Code: HBE
• UDI-Device Identifier: 00841036013165
• UDI-Public: (01)00841036013165(10)414103
• 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
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 08/16/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 01-7144
• Device Lot Number: 414103
• 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: 05/18/2023
• Supplement Date Received by Manufacturer: 07/07/2023; 04/18/2023; 08/05/2024
• Initial Report FDA Received Date: 06/13/2023
• Supplement Report FDA Received Date: 07/17/2023; 05/14/2024; 08/22/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/13/2022
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown