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

Model Number	BIO-COMP, SWIVELOCK C, FT, 4.75X19.1MM
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	07/24/2025
Type of Reportable Event	Malfunction
Event or Problem Description
On 25th july 2025, it was reported by a distributor via email that for an ar-2324bcct, suture anchor, biocomposite swivelock® c vented, 4.75 x 19.1 mm, with fibertape® loop (blue), the anchor was unable to screw in completely then it was found broken.Ar-1678-01 and ar-1678-05 were used to drill the pilot hole then ar-1927ctb was used for final tapping.All fragments were retrieved.This was detected during use in an acl reconstruction on (b)(6) 2025.The swivelock was used for acl back up fixation on tibial site.The procedure was completed successfully as ar-2324pslc peek swivelock was used to complete the 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.The complaint allegation was confirmed.One unpackaged ar-2324bcct batch 15383762 was received for evaluation.Visual evaluation revealed that the eyelet was bent and out of the shaft.The evaluation of the screw reveals damage, including bending, breaking, and warping of the threads.The evaluation of the molded outer shaft revealed warping and material breakage around the tip.Functional testing of the driver outer sleeve and the tb inner member molded swivelock found that the devices smoothly engage.The most likely cause of the reported failure is user error, which includes improper bone preparation, misaligned insertion, and/or prying or levering the device during insertion.These factors may have contributed to the malfunction or compromised the integrity of the implant during the procedure.Directions for use dfu-0087-eo at revision 5 - corkscrew, pushlock, and swivelock, suture anchors.G.Precautions 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.

• Brand Name: BIO-COMP, SWIVELOCK C, FT, 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: 22773448
• Report Number: 1220246-2025-03412
• Device Sequence Number: 9342095
• Product Code: MAI
• UDI-Device Identifier: 00888867026841
• UDI-Public: (01)00888867026841(11)250204(17)290131(10)15383762
• 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): 12/05/2025

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, FT, 4.75X19.1MM
• Device Catalogue Number: AR-2324BCCT
• Device Lot Number: 15383762
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/25/2025
• Supplement Date Received by Manufacturer: 12/03/2025
• Initial Report FDA Received Date: 08/11/2025
• Supplement Report FDA Received Date: 12/05/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/04/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown