MAUDE Adverse Event Report: ARTHREX, INC. DBL LOADED 4.75MM PEEK SWVLK; BIO SOFT TISSUE FIXATN FASTNR

Model Number	DBL LOADED 4.75MM PEEK SWVLK
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/14/2021
Type of Reportable Event	Malfunction
Event or Problem Description
On 09/21/2021, it was reported by a sales representative via e-mail that qty.3 of an ar-2324pslc-2 double loaded swivelocks broke during lateral row implantation.First the eyelet popped off while the surgeon was pulling the anchor over to the hole.Then unwound the eyelet suture and pulled tight to ¿re-seat¿ the eyelet, clamped the suture so the eyelet wouldn't slip off again.As the surgeon started to pull the anchor over to the hole a 2nd time, the eyelet suture severed at the eyelet/driver attachment.This occurred 3 times in a row in the exact same sequence.The case was completed by switching to a standard swivelock which implanted perfectly with no additional issue.No patient harm additional information provided 09/21/21: the procedure being performed was a rotator cuff repair.The case was completed by using an ar-2324pslc.Images of the device are attached.
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.Complaint is confirmed.The device was not returned for investigation, however images were provided.Review of the images with the product management team confirmed that the suture fraying during insertion was caused by the non-conformance identified within (b)(4).

• Brand Name: DBL LOADED 4.75MM PEEK SWVLK
• 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: jared engle ; 8009337001
• MDR Report Key: 19097146
• Report Number: 1220246-2024-02006
• Device Sequence Number: 7408024
• Product Code: MAI
• UDI-Device Identifier: 00888867251243
• UDI-Public: 00888867251243
• Combination Product (Y/N): N
• Initial Reporter State: UT
• Initial Reporter Country: US
• PMA/510(K) Number: K101823
• 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
• Report Date (Section B): 04/12/2024

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: 04/30/2026
• Device Model Number: DBL LOADED 4.75MM PEEK SWVLK
• Device Catalogue Number: AR-2324PSLC-2
• Device Lot Number: 13262585
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/21/2021
• Initial Report FDA Received Date: 04/12/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/06/2021
• 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