MAUDE Adverse Event Report: ARTHREX, INC. BIO-COMP SWVLK SP, 4.75X24.5MM; BIO SOFT TISSUE FIXATN FASTNR

Model Number	BIO-COMP SWVLK SP, 4.75X24.5MM
Medical Device Problem Code	Mechanical Jam (2983)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/28/2023
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
It was reported that during a knee surgery the wires jammed in the eyelet causing the anchor to pull out.There was no harm for patient, operator or third party.The surgery was finished successfully with a new device with the same part number.It was not necessary to switch the surgical technique or do a second surgery.***update nroe 12-dec-2023: further information revealed that the wire jammed in the eyelet, causing the anchor to pull out of the bone.No part of the device broke off.
Additional Manufacturer Narrative
This report is being submitted to provide additional information in d8/9, h3, h6: type of investigation, investigation findings, investigation conclusions, h10 and updated information in g1.Investigation summary: complaint is confirmed.Visual inspection identified that the swivelock eyelet was returned without screw, eyelet, and suture of the suture anchor, bio-composite swivelock® sp, 4.75 x 24.5 mm, self-punching, vented.Evaluation was performed per the picture attached to the case showing the bio-screw was bent.The method used to prepare the bone, as well as the bone quality encountered, was not provided.Per dfu-0087-eo revision 2.G.Precautions.3.Make sure to use the recommended drill bit or punch to create a bone socket.8.Self-punching pushlock and swivelock suture anchors only: ensure that the angle of anchor insertion is perpendicular to the bone.The most likely cause for the reported failure can be attributed to improper bone preparation, misalignment insertion of the device or prying/leveraging the device during insertion.Functional testing was not performed due to the damage to the device.

• Brand Name: BIO-COMP SWVLK SP, 4.75X24.5MM
• 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: 18394087
• Report Number: 1220246-2023-09611
• Device Sequence Number: 16877145
• Product Code: MAI
• UDI-Device Identifier: 00888867098039
• UDI-Public: 00888867098039
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K151342
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 06/27/2024

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: BIO-COMP SWVLK SP, 4.75X24.5MM
• Device Catalogue Number: AR-2324BCM-1
• Device Lot Number: 15109954
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/28/2023
• Supplement Date Received by Manufacturer: 06/03/2024
• Initial Report FDA Received Date: 12/26/2023
• Supplement Report FDA Received Date: 06/27/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/28/2023
• 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