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	Use of Device Problem (1670)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/15/2026
Type of Reportable Event	Malfunction
Event or Problem Description
On 16-jan-2026, it was reported by an arthrex subsidiary employee via (b)(4) that an ar-2324bcct biocomposite swivelock anchor did not adhere to the bone, becoming damaged (crushed) and preventing its insertion, so a second anchor was opened.It was further reported that a qty.2 of ar-2325bcc biocomposite swivelock anchors also did not adhere to the bone and became crushed.The case was completed by passing tape.This was discovered during a brostrom procedure with no patient harm.No delay was reported, no fragments remained in the patient, and no additional anesthesia was required.The patient¿s bone quality was reported as good.
Additional Manufacturer Narrative
Investigation is in process.A follow-up report will be provided upon availability of additional information.
Additional Manufacturer Narrative
Additional information: g3, h3, h6.The complaint allegation cannot be confirmed based on the provided photographic evidence for ar-2325bcc (batch 15304947), as the anchors are not visible in the images and are therefore insufficient for evaluation.Based on the available information¿including photographs, event description, and any additional field input¿the most likely cause is attributed to user-related factors, such as off-axis loading, prying, or levering of the device during use.

• 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: 24277344
• Report Number: 1220246-2026-00443
• Device Sequence Number: 12906564
• Product Code: MAI
• UDI-Device Identifier: 00888867026957
• UDI-Public: (01)00888867026957(11)240820(17)260731(10)15304947
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• PMA/510(K) Number: K101823
• 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): 05/27/2026

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 Expiration Date: 07/31/2026
• Device Model Number: BIO-COMP SWVLK 3.5X 15.8MM
• Device Catalogue Number: AR-2325BCC
• Device Lot Number: 15304947
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/16/2026
• Supplement Date Received by Manufacturer: 05/26/2026
• Initial Report FDA Received Date: 02/06/2026
• Supplement Report FDA Received Date: 05/27/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/20/2024
• 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