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

Model Number	BIO-COMP, SWIVELOCK C, TT, 4.75X19.1MM
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	12/01/2025
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
On 4th december 2025, it was reported by a distributor via email that for an ar-2324bcctt, suture anchor, biocomposite swivelock® c vented 4.75 x 19.1 mm, with tigertape® loop suture (white/black), the swivelock eyelet was broken during insertion into humeral head.Ar-1927pb was used to punch the hole.This was detected during use in a rct repair on (b)(6) 2025.The procedure was completed successfully as an additional swivelock was used.No fragment was left inside the patient.Bone density test was not performed.
Additional Manufacturer Narrative
Additional information: g3, h3, h6.The complaint device was not received for evaluation.Based on the information provided, which may include the returned device (if available), pictures, videos, event descriptions, and any additional field data, arthrex concluded the most likely cause of the reported failure.The most likely cause of the reported failure is a user error, including improper bone preparation and/or improper surgical technique associated with the device.Directions for use dfu-0087-eor6 corkscrew, pushlock, and swivelock, suture anchors g.Precautions 3.Make sure to use the recommended drill bit or punch to create the bone socket.4.Pushlock and swivelock suture anchors only: during anchor insertion, ensure that the angle of anchor insertion is coaxial to that of the previously prepared bone socket.The complaint allegation was not confirmed.No evidence of that failure was received.

• Brand Name: BIO-COMP, SWIVELOCK C, TT, 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: 23888019
• Report Number: 1220246-2025-05799
• Device Sequence Number: 11954932
• Product Code: MAI
• UDI-Device Identifier: 00888867026858
• UDI-Public: (01)00888867026858(11)250703(17)290630(10)15460765
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• 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): 04/02/2026

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, TT, 4.75X19.1MM
• Device Catalogue Number: AR-2324BCCTT
• Device Lot Number: 15460765
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/04/2025
• Supplement Date Received by Manufacturer: 04/02/2026
• Initial Report FDA Received Date: 12/24/2025
• Supplement Report FDA Received Date: 04/02/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/03/2025
• 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