MAUDE Adverse Event Report: ARTHREX, INC. 1.70MM DRILL FOR FIBERTAK; DRILL BIT

Model Number	1.70MM DRILL FOR FIBERTAK
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	08/21/2024
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 an instability surgery of the shoulder the drill broke off.It was not noted and the part remained inside the patient.The surgery was finished successfully with the same device.It was not necessary to switch the surgical technique or do a second surgery.No further information received.Update dw 04-sep-2024: further information was provided that the lot number of the device was found to be 022223.It was further reported that no additional surgery as it was confirmed on the ct that the part is embedded in the bone.
Additional Manufacturer Narrative
Complaint allegation is confirmed.One unpackaged ar-3600d-3 serial/batch number (b)(6) was received for investigation.Visual evaluation found that the drill shaft is broken/damaged.The method used to prepare the bone, as well as the bone quality encountered during the procedure, were not provided.The most likely cause for the reported failure can be attributed to improper bone prep; misaligned insertion; prying/leveraging the device during insertion.

• Brand Name: 1.70MM DRILL FOR FIBERTAK
• 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: 20217556
• Report Number: 1220246-2024-07613
• Device Sequence Number: 20808437
• Product Code: HTW
• UDI-Device Identifier: 00888867101920
• UDI-Public: 00888867101920
• Combination Product (Y/N): N
• Initial Reporter Country: SW
• 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): 01/27/2025

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 Model Number: 1.70MM DRILL FOR FIBERTAK
• Device Catalogue Number: AR-3600D-3
• Device Lot Number: 022223
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/28/2024
• Supplement Date Received by Manufacturer: 01/02/2025
• Initial Report FDA Received Date: 09/13/2024
• Supplement Report FDA Received Date: 01/27/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/01/2022
• 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