MAUDE Adverse Event Report: ARTHREX, INC. DRILL, FOR FIBERTAK DR; DRILL BIT

Model Number	DRILL, FOR FIBERTAK DR
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/26/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The reported event was confirmed as the visual evaluation of the received ar-3657 with batch 10491659 noted that the cutting-edge tip is broken off (see evaluation pictures 3 + 4).No broken pieces were returned for investigation.A functional test was not performed due to damage to the device.The most likely cause for the reported failure can be attributed to user error of the device due to applying excessive mechanical forces.
Event or Problem Description
It was reported that during the rotator cuff speedfix surgery, the tip of the drill broke off.The broken piece was retrieved from the patient.Per complaint reporter there was no harm for patient, operator or third party.The surgery was finished successfully with a new device with the same part number.It was not necessary to switch the surgical technique or do a second surgery.

• Brand Name: DRILL, FOR FIBERTAK DR
• 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: 25798627
• Report Number: 1220246-2026-03749
• Device Sequence Number: 5852271
• Product Code: HTW
• UDI-Device Identifier: 00888867225428
• UDI-Public: (01)00888867225428(11)191205(10)10491659
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: EXEMPT
• 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
• Report Date (Section B): 07/13/2026

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: DRILL, FOR FIBERTAK DR
• Device Catalogue Number: AR-3657
• Device Lot Number: 10491659
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/02/2026
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/09/2026
• Initial Report FDA Received Date: 07/13/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/05/2019
• 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: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown