MAUDE Adverse Event Report: ARTHREX, INC. 2.5MM DRILL BIT, CALIBRATED, REUSABLE; HTW

Model Number	2.5MM DRILL BIT, CALIBRATED, REUSABLE
Medical Device Problem Codes	Break (1069); Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/18/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Additional information: d9, g3, h3, h6.The reported event was confirmed as one unpackaged ar-8943-42-ru 2.5mm drill bit with batch number 917214 was received for investigation and the visual evaluation revealed that the tip of the returned device has broken off (see evaluation picture 3) and the shaft is bent / twisted (see evaluation picture4).The broken off fragments were not returned for investigation.Functional testing was not performed due to the damage to the device.The most likely cause for the reported failure can be attributed to user error of the device due to prying/leveraging the device during use.
Additional Manufacturer Narrative
Investigation is in process.A follow-up report will be provided upon availability of additional information.
Event or Problem Description
It was reported that during a surgery one drill bit bent during use (tip) and then the tip broke shortly before the end of the operation.No fragment remained inside the patient.Per complaint reporter there was no harm for patient, operator or third party.The surgery was finished successfully with the same device, since the tip broke off right at the end.It was not necessary to switch the surgical technique or do a second surgery.

• Brand Name: 2.5MM DRILL BIT, CALIBRATED, REUSABLE
• Common Device Name: HTW
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• Manufacturer (Section G): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• Manufacturer Contact: jared engle ; 8009337001
• MDR Report Key: 22999391
• Report Number: 1220246-2025-03755
• Device Sequence Number: 15702592
• Product Code: HTW
• UDI-Device Identifier: 00888867265769
• UDI-Public: (01)00888867265769(11)250206(10)917214
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Distributor
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 10/15/2025

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: 2.5MM DRILL BIT, CALIBRATED, REUSABLE
• Device Catalogue Number: AR-8943-42-RU
• Device Lot Number: 917214
• Was Device Available for Evaluation?: Yes
• Distributor Facility Aware Date: 08/18/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/18/2025
• Supplement Date Received by Manufacturer: 10/08/2025
• Initial Report FDA Received Date: 09/08/2025
• Supplement Report FDA Received Date: 10/15/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/06/2025
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown