MAUDE Adverse Event Report: ARTHREX, INC. BIO-COMPOSITE CRKSCRW 5.5X14.9MM; BIO SOFT TISSUE FIXATN FASTNR

Model Number	BIO-COMPOSITE CRKSCRW 5.5X14.9MM
Medical Device Problem Code	Positioning Failure (1158)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/04/2026
Type of Reportable Event	Malfunction
Event or Problem Description
On 06-feb-2026, a sales representative reported via email that an ar-1927bcf-3 5.5 mm biocomposite corkscrew ft tripleplay exhibited an issue during a procedure performed on (b)(6) 2026.While the surgeon was tying the medial row, he observed a visual cue on the monitor and stated that he felt the suture ¿pop.¿ the mechanism within the implant that secures the sutures appeared to fail, resulting in the previously tied suture becoming loose, as well as the suture he was actively tying.The surgeon cut the affected sutures from the cuff tissue, removed the sutures from the implant, and subsequently removed the implant using the original disposable blue-handled inserter.The implant was replaced with a larger 6.5 mm double-loaded anchor.The surgeon elected to upsize due to concern that the original bone hole may have been compromised, although no visual or other evidence confirmed this.The event resulted in a case delay with less than 10 minutes of additional anesthesia time.No patient harm was reported.
Additional Manufacturer Narrative
Additional information: b5, d9, g3, h3, h6.Additional information was received on 26-feb-2026: this was discovered during an rcr procedure.The case was completed using an ar-1927bcf-65 biocomposite corkscrew ft.No adverse patient effects have been reported during or following the procedure due to this issue.
Event or Problem Description
Additional information: this was discovered during an rcr procedure.The case was completed using an ar-1927bcf-65 biocomposite corkscrew ft.No adverse patient effects have been reported during or following the procedure due to this issue.

• Brand Name: BIO-COMPOSITE CRKSCRW 5.5X14.9MM
• 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: 24433811
• Report Number: 1220246-2026-00903
• Device Sequence Number: 10304177
• Product Code: MAI
• UDI-Device Identifier: 00888867023369
• UDI-Public: (01)00888867023369(11)251216(17)291130(10)15545964
• Combination Product (Y/N): N
• Initial Reporter State: OR
• Initial Reporter Country: US
• PMA/510(K) Number: K082810
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 06/01/2026

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-COMPOSITE CRKSCRW 5.5X14.9MM
• Device Catalogue Number: AR-1927BCF-3
• Device Lot Number: 15545964
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/06/2026
• Supplement Date Received by Manufacturer: 05/29/2026
• Initial Report FDA Received Date: 02/24/2026
• Supplement Report FDA Received Date: 06/01/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/16/2025
• 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