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

Model Number	FIBERTAK DISPOSABLES CURVED KIT
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/30/2024
Type of Reportable Event	Malfunction
Event or Problem Description
On (b)(6) 2024 it was reported by a sales representative via phone that an ar-3600-2 fibertak suture anchor and an ar-3638dc knotless fibertak disposable kit, curved had an issue during a shoulder rotator cuff repair procedure with biceps tenodesis on (b)(6) 2024.The surgeon put the drill guide on, drilled and inserted the suture anchor through the drill guide, when a plastic part of the anchor inserter that was outside of the patient broke off inside the drill guide.The inserter could not be removed from the drill guide, they had fused together.When removing the inserter together with the drill guide from the patient, the knotless suture anchor was pulled out as well.Nothing broke off inside the patient, the broken plastic piece was contained within the drill guide and everything was removed.The same spot was used, the hole was made bigger and an ar-1927psf-475 suture anchor, peek corkscrew ft with an unknown lot number was used to complete the procedure successfully with no harm to the patient.There was no case delay reported, and no additional anesthesia was administered.The complaint devices were discarded, but pictures were taken.This occurred during use with no reported patient harm.
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
The complaint allegation is confirmed based on the customer-provided pictures.Visual evaluation of the customer-provided pictures noted an ar-3638dc knotless fibertak disposable kit, curved broke off inside the drill guide.Refer to attachments.Based on the information provided, arthrex was able to conclude a most likely cause.The most likely cause for the reported failure can be attributed to user error of the device due to excessive force being used during insertion of the implant.

• 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: 19614139
• Report Number: 1220246-2024-06422
• Device Sequence Number: 14987712
• Product Code: LXH
• UDI-Device Identifier: 00888867287433
• UDI-Public: 00888867287433
• 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
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/01/2025

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: 15122912
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/31/2024
• Supplement Date Received by Manufacturer: 06/06/2025
• Initial Report FDA Received Date: 06/26/2024
• Supplement Report FDA Received Date: 07/01/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/01/2023
• 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