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	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/04/2026
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
On 19-mar-2026, a sales representative reported via email that an ar-1927bcf-3 biocomposite corkscrew ft tripleplay 5.5 mm anchor broke during insertion.The implant was placed into the patient¿s shoulder during a rotator cuff repair procedure on (b)(6) 2026, and the surgeon observed the screw breaking before it had fully engaged the bone.No patient harm was reported.

• 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: 24832693
• Report Number: 1220246-2026-02104
• Device Sequence Number: 9222123
• Product Code: MAI
• UDI-Device Identifier: 00888867023369
• UDI-Public: (01)00888867023369(11)250911(17)290831(10)15497297
• Combination Product (Y/N): N
• Initial Reporter State: WI
• 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): 05/21/2026

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: 15497297
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/19/2026
• Supplement Date Received by Manufacturer: 05/14/2026
• Initial Report FDA Received Date: 04/09/2026
• Supplement Report FDA Received Date: 05/21/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/11/2025
• 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