MAUDE Adverse Event Report: ARTHREX, INC. FIBERTAK DISPOSABLES CURVED KIT; ORTHOPEDIC MANUAL SURG INSTR

Model Number	FIBERTAK DISPOSABLES CURVED KIT
Medical Device Problem Code	Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	04/12/2024
Type of Reportable Event	Malfunction
Event or Problem Description
On 15 april 2024 it was reported by a sales representative via email that there had been an incident with an ar-3638dc fibertak disposables curved kit.This occurred during a shoulder stabilisation in (b)(6) hospital on (b)(6) 2024.The surgeon drilled the pilot hole using the drill and drill guide from the pack.When the anchor was being inserted the sleeve did not allow the anchor to slide in.A second anchor was opened and had the same issue.A new drill guide pack was opened and this worked and allowed the case to be completed successfully.There was case/patient involvement.
Additional Manufacturer Narrative
The contribution of the device to the reported event could not be determined as the device was not returned for evaluation.The root cause of the event could not be determined from the information available and without device evaluation.If the device becomes available for evaluation, a follow-up report will be submitted.
Additional Manufacturer Narrative
Additional information: b3, 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 misuse/mishandling due to damage to the device.

• Brand Name: FIBERTAK DISPOSABLES CURVED KIT
• Common Device Name: ORTHOPEDIC MANUAL SURG INSTR
• 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: 19497990
• Report Number: 1220246-2024-05373
• Device Sequence Number: 12446284
• Product Code: LXH
• UDI-Device Identifier: 00888867287433
• UDI-Public: 00888867287433
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• 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): 06/24/2025

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: FIBERTAK DISPOSABLES CURVED KIT
• Device Catalogue Number: AR-3638DC
• Device Lot Number: 15145746
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/12/2024
• Supplement Date Received by Manufacturer: 06/04/2025
• Initial Report FDA Received Date: 06/10/2024
• Supplement Report FDA Received Date: 06/24/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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