MAUDE Adverse Event Report: ARTHREX, INC. 4.75MM BC KNOTLESS SWIVELOCK W/ TAPE; BIO SOFT TISSUE FIXATN FASTNR

Model Number	4.75MM BC KNOTLESS SWIVELOCK W/ TAPE
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Codes	Failure of Implant (1924); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/06/2023
Type of Reportable Event	Malfunction
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.
Event or Problem Description
On 9/7/2023, it was reported by a sales representative via email that an ar-2324kbcct knotless biocomposite swivelock eyelet broke completely during insertion, releasing the fibertape loop.When the surgeon opened the package, it was noticed that the eyelet of the swivelock looked different; it was somehow defective and appeared to have a crack with the fibertape loop partially lodged in it.The surgeon attempted to use the swivelock anyway, in which the eyelet broke.Everything was removed, and the case was completed using another ar-2324kbcct knotless biocomposite swivelock from the same lot number.This was discovered during an rcr procedure on (b)(6) 2023.Additional information received on 9/7/2023: the surgeon removed all the broken fragments.The case was only delayed twenty to thirty seconds and additional anesthesia was not necessary.
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 causes of the reported failure are improper bone preparation, misaligned insertion, and prying/leveraging the device during insertion.

• Brand Name: 4.75MM BC KNOTLESS SWIVELOCK W/ TAPE
• Common Device Name: BIO SOFT TISSUE FIXATN FASTNR
• 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: 17890289
• Report Number: 1220246-2023-08096
• Device Sequence Number: 15188169
• Product Code: MAI
• UDI-Device Identifier: 10888867351124
• UDI-Public: 10888867351124
• Combination Product (Y/N): N
• Initial Reporter State: NE
• Initial Reporter Country: US
• PMA/510(K) Number: K193503
• 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): 10/17/2024

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: 4.75MM BC KNOTLESS SWIVELOCK W/ TAPE
• Device Catalogue Number: AR-2324KBCCT
• Device Lot Number: 15051243
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/07/2023
• Supplement Date Received by Manufacturer: 10/08/2024
• Initial Report FDA Received Date: 10/06/2023
• Supplement Report FDA Received Date: 10/17/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/01/2023
• 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