MAUDE Adverse Event Report: ARTHREX, INC. 1.8MM DRILL BIT, KNOTLESS HIP FIBERTAK

Model Number	1.8MM DRILL BIT, KNOTLESS HIP FIBERTAK
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/02/2024
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
On (b)(6)2024, a distributor via (b)(4) reported that an ar-3600d-2h drill for a hip fibertak suture anchor broke during use.This issue occurred when the surgeon put in the first anchor of a labral repair.The trajectory of the drill & guide was good; when the surgeon drilled to the guide's hard stop, the drill tip broke off in the bone.The surgeon was able to burr around the drill bit & use a chondral pick to create space around the drill bit.The surgeon then grasped the end of the drill bit with a kingfisher & removed the broken piece and confirmed.No adverse effects on the patient were reported, and no secondary surgery was needed.This was discovered during a hip arthroscopy procedure with labral repair on (b)(6)2024.Additional information was received on 10/08/2024: there was 8 minutes of case delay with no added anesthesia administered.
Additional Manufacturer Narrative
Additional information: g3, h3, h6 based on the information provided which may include the device (if available and returned), pictures, videos, event description, and any additional information from the field, arthrex was able to conclude a most likely cause.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: 1.8MM DRILL BIT, KNOTLESS HIP 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: 20513483
• Report Number: 1220246-2024-08216
• Device Sequence Number: 7203864
• Product Code: HTW
• UDI-Device Identifier: 00888867298019
• UDI-Public: (01)00888867298019(11)230418(10)022315
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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,Followup
• Report Date (Section B): 07/07/2025

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: 1.8MM DRILL BIT, KNOTLESS HIP FIBERTAK
• Device Catalogue Number: AR-3600D-2H
• Device Lot Number: 022315
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/04/2024
• Supplement Date Received by Manufacturer: 06/10/2025
• Initial Report FDA Received Date: 10/23/2024
• Supplement Report FDA Received Date: 07/07/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/18/2023
• 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