MAUDE Adverse Event Report: ARTHREX, INC. 1.7MM DRILL BIT, REUSABLE

Model Number	1.7MM DRILL BIT, REUSABLE
Medical Device Problem Code	Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/14/2026
Type of Reportable Event	Malfunction
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 the two drill bits were complete but bent or folded, making them unusable.No parts were missing, so there was no loss during surgery.There was no harm for patient, operator or third party reported.No further information was provided.
Event or Problem Description
Update 05-mar-2026.It was confirmed that the error occurred during an orthopedic surgery.The surgery was finished successfully with a different device (disposable).It was not necessary to switch the surgical technique or do a second surgery.
Additional Manufacturer Narrative
Additional information: b5, d9, g3, h3, h6.The reported event was confirmed as one unpackaged ar-8916-14-ru, 1.7mm drill bit, reusable, batch number 917672, was received for investigation and upon visual inspection, it was observed that the drill is slightly bent (see evaluation pictures 1 + 3).Functional testing was not performed due to the damage of the device.The most likely cause for the reported failure can be attributed to improper bone prep, misaligned insertion or prying/leveraging the device during use.

• Brand Name: 1.7MM DRILL BIT, REUSABLE
• Common Device Name: DRILL BIT
• 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: 24259479
• Report Number: 1220246-2026-00414
• Device Sequence Number: 9513666
• Product Code: HTW
• UDI-Device Identifier: 00888867272682
• UDI-Public: 00888867272682
• Combination Product (Y/N): N
• Initial Reporter Country: LU
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 03/31/2026

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: 1.7MM DRILL BIT, REUSABLE
• Device Catalogue Number: AR-8916-14-RU
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/14/2026
• Supplement Date Received by Manufacturer: 03/31/2026
• Initial Report FDA Received Date: 02/04/2026
• Supplement Report FDA Received Date: 03/31/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown