MAUDE Adverse Event Report: ARTHREX, INC. BIO-COMP SWVLK C, CLD 4.75X19.1MM; BIO SOFT TISSUE FIXATN FASTNR

Model Number	BIO-COMP SWVLK C, CLD 4.75X19.1MM
Medical Device Problem Codes	Positioning Failure (1158); Damaged Thread (4075)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/06/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Investigation is in process.A follow-up report will be provided upon availability of additional information.
Event or Problem Description
It was reported that during a collateral ligament repair surgery the implant thread did not work, it did not push the screw all the way down into the hole.Per complaint reporter 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.
Additional Manufacturer Narrative
Additional information: d9, g3, h3, h6.Complaint allegation is confirmed.Visual inspection identified that the tip of the anchor was broken off and the threads were damaged/stripped.The tip of the outer sleeve had been broken off and damaged.The eyelet and suture were not returned with the device.Functional testing confirmed that the outer sleeve threaded smoothly onto the driver without resistance.The method of bone preparation and the quality of the bone encountered were not specified.The most likely cause for the reported failure can be attributed to user error of the device due to improper bone preparation, misalignment insertion, and/or prying/leveraging of the device during insertion.

• Brand Name: BIO-COMP SWVLK C, CLD 4.75X19.1MM
• 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: 22236611
• Report Number: 1220246-2025-02487
• Device Sequence Number: 8976863
• Product Code: MAI
• UDI-Device Identifier: 00888867097988
• UDI-Public: (01)00888867097988(11)240607(17)280531(10)15270838
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• PMA/510(K) Number: K203495
• 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): 08/18/2025

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 C, CLD 4.75X19.1MM
• Device Catalogue Number: AR-2324BCC-1
• Device Lot Number: 15270838
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/22/2025
• Supplement Date Received by Manufacturer: 08/11/2025
• Initial Report FDA Received Date: 06/17/2025
• Supplement Report FDA Received Date: 08/18/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/07/2024
• 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