MAUDE Adverse Event Report: BIOMET MICROFIXATION TW DRILL 1.1X50MM 7MMSTOP W/NT; FLUTED SURGICAL DRILL BIT, REUSABLE

Catalog Number	01-7144
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/16/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the drill was broken during a procedure.All debris/fragments were recovered.Attempts have been made and additional information on the reported event is unavailable at this time.
Additional Manufacturer Narrative
(b)(4).G2: 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.The following sections were updated: b4, b5, e1, g3, g6, h2, h3, h4, h6, h11.H6: suggested component code- mechanical (g04) ¿ drill.No product was returned.A visual inspection was conducted on the customer provided pictures.The pictures show that a clear fracture occurred near where the fluted portion of the drill tip meets the drill body.The complaint is confirmed a determination cannot be made as to what caused the drill 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 provided photos.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 is available at the time of this report.

• Brand Name: TW DRILL 1.1X50MM 7MMSTOP W/NT
• Common Device Name: FLUTED SURGICAL DRILL BIT, REUSABLE
• 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: 20612258
• Report Number: 0001032347-2024-00341
• Device Sequence Number: 20815624
• Product Code: HBE
• UDI-Device Identifier: 00841036013165
• UDI-Public: (01)00841036013165(10)350632
• 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): 02/27/2025

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 Catalogue Number: 01-7144
• Device Lot Number: 350632
• 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: 10/21/2024
• Supplement Date Received by Manufacturer: 02/27/2025
• Initial Report FDA Received Date: 11/05/2024
• Supplement Report FDA Received Date: 02/27/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/05/2019
• 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: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown