MAUDE Adverse Event Report: ARTHREX, INC. BIO-COMP SWIVELOCK C, CLD 5.5X19.1MM; BIO SOFT TISSUE FIXATN FASTNR

Model Number	BIO-COMP SWIVELOCK C, CLD 5.5X19.1MM
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/09/2026
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 the rotator cuff surgery, the anchor broke during insertion.No broken pieces remained in 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
Additional information: d9, g3, h3, h6.One unpackaged ar-2323bcc swivelock®, batch 15480734, was received for evaluation.Returned components: sutures, o-ring, and eyelet.The anchor was not returned, preventing a complete evaluation of the reported issue.The eyelet was found detached from the device.No other components of the implant were available for review.Functional testing was not performed due to the condition of the returned components.Based on the condition of the returned eyelet, the most likely cause of the failure is use-related mechanical overload at the distal end, potentially associated with: off-axis insertion prying or leveraging the device inadequate bone preparation the complaint allegation cannot be confirmed, as the anchor¿critical to evaluating the reported failure mode was not returned for investigation.Refer to the investigation photos.

• Brand Name: BIO-COMP SWIVELOCK C, CLD 5.5X19.1MM
• 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: 24178475
• Report Number: 1220246-2026-00314
• Device Sequence Number: 9569335
• Product Code: MAI
• UDI-Device Identifier: 00888867026728
• UDI-Public: (01)00888867026728(11)250811(17)290731(10)15480734
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K203495
• 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): 04/09/2026

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 SWIVELOCK C, CLD 5.5X19.1MM
• Device Catalogue Number: AR-2323BCC
• Device Lot Number: 15480734
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/09/2026
• Supplement Date Received by Manufacturer: 04/08/2026
• Initial Report FDA Received Date: 01/26/2026
• Supplement Report FDA Received Date: 04/09/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/11/2025
• 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