MAUDE Adverse Event Report: BIOMET MICROFIXATION 1.8X115MM 26MM STOP DRILL; 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	10/22/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the tip of the drill fractured when the surgeon tested it prior to use by attaching the drill to a power tool and rotating it on a clean table.This was not the first use of the drill.It was reported that no further information is available.
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 is available at the time of this report.
Additional Manufacturer Narrative
This follow-up report is being submitted to relay additional information.The following sections were updated: b4, b5, g3, g6, h2, h3, h4, h6, h11 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.Further inspection shows that the drill has fractured near where the fluted portion of drill meets the drill base.The complaint is confirmed.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 and the product was 100% inspected.The product has an estimated field age of five years and there was no reported patient harm.The root cause of the reported issue is attributed to a user error.The ifu for this device states in the warnings/precautions section that this ¿device is single use only.¿ the ifu also states in the instructions for use section that the ¿twist drill should not be revved prior to contact with the bone.Revving the drill prior to contact with the bone may cause breakage of the drill, injury to the patient or damage to surrounding tissue.¿ 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.

• Brand Name: 1.8X115MM 26MM STOP DRILL
• 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: 20696011
• Report Number: 0001032347-2024-00352
• Device Sequence Number: 17089463
• Product Code: HBE
• UDI-Device Identifier: 00841036128029
• UDI-Public: (01)00841036128029(10)327608
• 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): 03/13/2025

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 Model Number: N/A
• Device Catalogue Number: 46-1004
• Device Lot Number: 327608
• Was Device Available for Evaluation?: No
• 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: 10/24/2024
• Supplement Date Received by Manufacturer: 03/11/2025
• Initial Report FDA Received Date: 11/15/2024
• Supplement Report FDA Received Date: 03/13/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/29/2019
• 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: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown