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

Model Number	DBL LOADED 4.75MM BIO-COMP SWVLK
Medical Device Problem Code	Material Frayed (1262)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/06/2022
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 is confirmed.The device was not returned for evaluation, but a photograph was provided.The photograph displays two sutures: a white/black tigerwire on the left and a white/blue tigerwire on the right.Each tigerwire contains a small frayed portion no larger than 3 inches.The portions distal and proximal to the fraying appear to be intact.Since there are no indications that the failure was discovered before usage, it is probable that during use the sutures rubbed against a rough surface such as bone, another instrument, or the edge of an implant, causing the fraying seen in the photograph.Therefore, the most likely cause to the failure observed can be attributed to use error.
Event or Problem Description
On 1/14/2022, it was reported by an arthrex employee via email that an ar-2324bcc-2 bio composite swivelock internal threads of the anchor broke.Surgeon used an ar-7201 to complete the procedure.This was discovered during a rcr on (b)(6) 2022.Additional information received 1/21/2022: after inserting the swivelock and completing the speedbridge repair, the internal wires of the anchor broke and surgeon had to use an ar-7201 fiberwire to reinforce the sutures.The anchor and eyelet remain implanted successfully inside the patient.

• Brand Name: DBL LOADED 4.75MM BIO-COMP 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: 19220950
• Report Number: 1220246-2024-02674
• Device Sequence Number: 20624560
• Product Code: MAI
• UDI-Device Identifier: 00888867097995
• UDI-Public: 00888867097995
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• PMA/510(K) Number: K101823
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 05/01/2024

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: 03/31/2025
• Device Model Number: DBL LOADED 4.75MM BIO-COMP SWVLK
• Device Catalogue Number: AR-2324BCC-2
• Device Lot Number: 13208906
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/14/2022
• Initial Report FDA Received Date: 05/01/2024
• Date Device Manufactured: 04/28/2021
• 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