MAUDE Adverse Event Report: ARTHREX, INC. FIBERTAK WITH #2 TIGERTAIL DOUBLE LOADED; NON-DEGRADABLE FIXATION FASTENER

Model Number	FIBERTAK WITH #2 TIGERTAIL DOUBLE LOADED
Medical Device Problem Code	Positioning Failure (1158)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	01/27/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the anchor ar-3603-2 would not seat.The site had been pre-drilled but would seat when malleted.It was removed from the patient and the labral repair case was completed with suturetaks.There were no additional incisions needed.Patient 18 year old male.
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.Based off the information provided, the most likely cause for the reported failure can be attributed to improper bone prep and/or misaligned insertion.As no further investigation was able to be performed no change in harm was identified.

• Brand Name: FIBERTAK WITH #2 TIGERTAIL DOUBLE LOADED
• 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: emily shafer ; 8009337001
• MDR Report Key: 19321643
• Report Number: 1220246-2024-03318
• Device Sequence Number: 12352025
• Product Code: MBI
• UDI-Device Identifier: 00888867231320
• UDI-Public: 00888867231320
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: K181769
• 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): 05/15/2024

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 Expiration Date: 05/31/2025
• Device Model Number: FIBERTAK WITH #2 TIGERTAIL DOUBLE LOADED
• Device Catalogue Number: AR-3603-2
• Device Lot Number: 11089254
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/27/2021
• Initial Report FDA Received Date: 05/15/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/11/2020
• 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 Age: 18 YR
• Patient Sex: Male