MAUDE Adverse Event Report: ARTHREX, INC. SP FBRTAK RC FBRTPE BLU & STTPE WH/BLK; NON-DEGRADABLE FIXATION 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	06/08/2022
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.Based off the information provided, the most likely cause for the reported failure can be attributed to user error due to misaligned insertion and/or improper bone preparation.
Event or Problem Description
On 6/9/2022, it was reported by a sales representative via email that an ar-3652ttsp fibertak rc suture anchor was not able to be fixed and was sliding freely through the anchor.Then, while implanting an ar-3652tsp fibertak rc suture anchor, blue, and an ar-3652sp fibertak rc suture anchor, white and black, both pulled out of implantation site.This was discovered during an rcr procedure on (b)(6) 2022.Additional information requested.When the fibertak rc suture anchor was not able to be fixed, surgeon cut out the sutures and removed the anchor.A 4.75 swivelock was opened and used successfully.When ar-3652tsp pulled out, surgeon completely removed it and used an ar-3652sp, however, this one too pulled out.Surgeon completely removed all remaining sutures and used another 4.75 swivelock to complete the case.Also, a speedbridge construct and additional cuffmend augmentation was used to complete the case.Nothing broke inside the patient.

• Brand Name: SP FBRTAK RC FBRTPE BLU & STTPE WH/BLK
• 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: 19277680
• Report Number: 1220246-2024-03015
• Device Sequence Number: 12674745
• Product Code: MBI
• UDI-Device Identifier: 10888867362922
• UDI-Public: 10888867362922
• Combination Product (Y/N): N
• Initial Reporter State: MI
• 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: 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: SP FBRTAK RC FBRTPE BLU & STTPE WH/BLK
• Device Catalogue Number: AR-3652TSP
• Device Lot Number: 14955349
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/09/2022
• Initial Report FDA Received Date: 05/09/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/29/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown