MAUDE Adverse Event Report: ARTHREX, INC. BIO-COMP SWVLK 3.5X 15.8MM; BIO SOFT TISSUE FIXATN FASTNR

Model Number	BIO-COMP SWVLK 3.5X 15.8MM
Medical Device Problem Code	Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/27/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Additional information: d9, g3, h3, h6.¿ the complaint allegation could not be confirmed due to the alleged torn anchor not being returned with the device.¿ one unpackaged ar-2325bcc-1 serial/batch number (b)(6)was received for investigation.¿ functional testing was not performed due to the anchor not being returned with the device.¿ visual inspection noted that the device shows obvious signs of use and was returned without the anchor.Also, there is no significant damage or destruction to the device.¿ the most likely cause of the reported allegation can be attributed to improper bone preparation, misaligned insertion, or prying/leveraging during insertion.
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 the labral repair, the anchor torn.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.09-dec-2025 majung - further information was received from arthrex cz: no fragments remained in the patient.

• Brand Name: BIO-COMP SWVLK 3.5X 15.8MM
• 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: 23829766
• Report Number: 1220246-2025-05666
• Device Sequence Number: 9288647
• Product Code: MAI
• UDI-Device Identifier: 00888867283626
• UDI-Public: (01)00888867283626(11)250501(17)270430(10)15429485
• Combination Product (Y/N): N
• Initial Reporter Country: EZ
• PMA/510(K) Number: K101823
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Distributor
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 02/25/2026

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 3.5X 15.8MM
• Device Catalogue Number: AR-2325BCC-1
• Device Lot Number: 15429485
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/27/2025
• Supplement Date Received by Manufacturer: 02/25/2026
• Initial Report FDA Received Date: 12/17/2025
• Supplement Report FDA Received Date: 02/25/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/01/2025
• 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