MAUDE Adverse Event Report: ARTHREX, INC. 8MM FLEX DRILL, KNOTLESS HIP FIBERTAK; DRILL BIT

Model Number	8MM FLEX DRILL, KNOTLESS HIP FIBERTAK
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/17/2023
Type of Reportable Event	Malfunction
Event or Problem Description
On (b)(6) 2023, it was reported by a sales representative via e-mail that (3) ar-3636h 1.8 knotless hip fibertaks, and (2) ar-3600nd-2h disposable drills failed.This occurred during an arthroscopic hip labral repair on (b)(6) 2023 when drilling for the anchors it felt as if the device was chatting up against the curved guide.The guide was pulled out of the hip and ran the drill through it with the same result.The drill guide was switched out and the same issue occurred.An additional drill bit was tried and the issue persisted.A third drill bit with a different lot number and the same drill guide was tried and there was no chatter of the drill bit.After the guide and drill bit issue was resolved and they began inserting the anchors, 3 of the anchors pulled out.They also tried reloading each of these anchors and reinserting and they still pulled out.It wasn¿t until they opened an anchor of a different lot number that the anchor held in the bone.The patient had an unusually hard bone.There was no patient effect reported.
Additional Manufacturer Narrative
This 3500a record is submitted to comply with an fda 483 inspectional observation issued to arthrex inc on (b)(6) 2023.Arthrex has reassessed the reportability decisions made on historical complaint records using revised criterion.This 3500a document is a result of the reassessment.The complaint device was not received for evaluation.Based off the information provided, the most likely cause for the reported failure can be attributed to user error of the device due to misaligned insertion.

• Brand Name: 8MM FLEX DRILL, 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: 19497624
• Report Number: 1220246-2024-05362
• Device Sequence Number: 12465572
• Product Code: HTW
• UDI-Device Identifier: 00888867298026
• UDI-Public: 00888867298026
• Combination Product (Y/N): N
• Initial Reporter State: ID
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date (Section B): 06/10/2024

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: 8MM FLEX DRILL, KNOTLESS HIP FIBERTAK
• Device Catalogue Number: AR-3600ND-2H
• Device Lot Number: 15032910
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/17/2023
• Initial Report FDA Received Date: 06/10/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown