MAUDE Adverse Event Report: ARTHREX, INC. SELF-PUNCHING TRIPLE LOADED FIBERTAK; NON-DEGRADABLE FIXATION FASTENER

Model Number	SELF-PUNCHING TRIPLE LOADED FIBERTAK
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/01/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This 3500a record is submitted to comply with an fda 483 inspectional observation issued to arthrex inc on may 5, 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.The most likely cause for the reported failure can be attributed to user error due to improper bone prep; misaligned insertion; prying/leveraging the device during insertion.As no further investigation was able to be performed no change in harm was identified.
Event or Problem Description
On 12/03/2021, it was reported by a sales representative via e-mail that a ar-3633sp fibertak backed out.This occurred on (b)(6) 2021 during a quadriceps tendon repair when the fibertak drilled through the drill guide to a hard stop in the medial third of the superior patellar pole.The anchor was impacted to the midpoint of the long laser line.The suture release tab was removed as well as the inserter.The surgeon began to pull all six suture limbs out and the anchor immediately backed out from the bone.The anchor was reloaded, reinserted into the bone approximately to the midpoint of the long laser line, inserter was removed again, and once again the anchor backed out.These exact steps were taken a third time and once more the same result of the anchor backing out.The case was completed with a new hole being drilled, and a new anchor was opened and inserted without any issues.There was no patient effect reported.

• Brand Name: SELF-PUNCHING TRIPLE LOADED FIBERTAK
• Common Device Name: NON-DEGRADABLE FIXATION FASTENER
• 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: 19278405
• Report Number: 1220246-2024-03032
• Device Sequence Number: 15351601
• Product Code: MBI
• UDI-Device Identifier: 10888867369969
• UDI-Public: 10888867369969
• Combination Product (Y/N): N
• Initial Reporter State: CT
• Initial Reporter Country: US
• PMA/510(K) Number: K200341
• 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
• Report Date (Section B): 05/09/2024

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: SELF-PUNCHING TRIPLE LOADED FIBERTAK
• Device Catalogue Number: AR-3633SP
• Device Lot Number: 13969
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/03/2021
• Initial Report FDA Received Date: 05/09/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown