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	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/05/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a medial patellofemoral ligament reconstruction after the implantation of the anchor while the surgeon tried to knot the sutures the tip of the anchors broke off.The broken pieces were retrieved out of the patient.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
Investigation is in process.A follow-up report will be provided upon availability of additional information.
Additional Manufacturer Narrative
Additional information: d9, g3, h3, h6.One unpackaged ar-2325bcc swivelock®, batch 15434612, was received for investigation.Visual inspection noted that only a fragment of the suture and anchor was returned for evaluation.Functional testing was not performed due to the condition and damage of the returned fragment.The most likely cause of the reported failure can be attributed to: excessive mechanical force is applied to the anchor construct during knot tying prying or leveraging the device during use.The complaint allegation is confirmed.See attached investigation photos.

• 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: 23678938
• Report Number: 1220246-2025-05233
• Device Sequence Number: 10406104
• Product Code: MAI
• UDI-Device Identifier: 00888867026957
• UDI-Public: (01)00888867026957(11)250512(17)270430(10)15434612
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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): 02/11/2026

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
• Device Lot Number: 15434612
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/06/2025
• Supplement Date Received by Manufacturer: 01/27/2026
• Initial Report FDA Received Date: 12/01/2025
• Supplement Report FDA Received Date: 02/11/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/12/2025
• 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