MAUDE Adverse Event Report: ARTHREX, INC. SP FBRTAK RC FBRTPE BLU & STTPE WH/BLK; NON-DEGRADABLE FIXATN FASTENER

Model Number	SP FBRTAK RC FBRTPE BLU & STTPE WH/BLK
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/17/2024
Type of Reportable Event	Malfunction
Event or Problem Description
On 04/19/2024, it was reported by a sales representative via email that an ar-3652tsp fibertak rc pulled out.The anchor was placed in the posterior aspect of the greater tuberosity through an ar-1941ds knotless corkscrews disposable instrument kit in a self-punching manner.No decortication was done in prep.The suturetapes were passed first posteriorly one at a time, and then the swedged fibertapes were passed together lastly from a posterior to anterior direction.There was an additional anterior fibertak placed and passed similarly.Upon placing half of these sutures into the lateral row of an ar-2323kpslc peek knotless swivelock, the anchor popped off of the bone when pulling tension on the sutures.There was no excessive force being pulled, and the sutures just had the slack taken out, nothing more.This happened before the lateral swivelock was started into the bone.The anchor and all of its sutures were retrieved in its entirety.The patient was not harmed.A 5.5mm swivelock, loaded with tapes, was opened and placed in the hole the fibertak came out of.Sufficient purchase was achieved, and the case was completed.The case was delayed fifteen minutes.This was discovered during a rotator cuff repair procedure on (b)(6) 2024.
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: 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 can be attributed to misaligned insertion; or prying/leveraging the device during use.

• Brand Name: SP FBRTAK RC FBRTPE BLU & STTPE WH/BLK
• Common Device Name: NON-DEGRADABLE FIXATN 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: 19326112
• Report Number: 1220246-2024-03353
• Device Sequence Number: 2685731
• Product Code: MBI
• UDI-Device Identifier: 10888867362922
• UDI-Public: 10888867362922
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• PMA/510(K) Number: K232973
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 06/12/2025

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: SP FBRTAK RC FBRTPE BLU & STTPE WH/BLK
• Device Catalogue Number: AR-3652TSP
• Device Lot Number: 15178757
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/19/2024
• Supplement Date Received by Manufacturer: 05/18/2025
• Initial Report FDA Received Date: 05/15/2024
• Supplement Report FDA Received Date: 06/12/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/11/2023
• 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