MAUDE Adverse Event Report: ARTHREX, INC. BIO-COMPSI CRKSCRW FT 4.5X 14MM; BIO SOFT TISSUE FIXATN FASTNR

Model Number	BIO-COMPSI CRKSCRW FT 4.5X 14MM
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/09/2026
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
On (b)(6) 2026, it was reported by an arthrex's employee via an email that for 2 units of ar-1927bcf-45, 4.5 mm biocomposite-corkscrew® ft suture anchor with one #2 fiberwire® and one tigerwire®, both the anchors broke during insertion.The 1st ar-1927bcf-45 broke during insertion, and another ar-1927bcf-45 was changed to, but the same issue happened again.This was detected during an arthroscopic shoulder surgery for rotator cuff repair surgery on (b)(6) 2026.The procedure was completed successfully by using a third ar-1927bcf-45.There were no patient harm and no secondary procedure needed.

• Brand Name: BIO-COMPSI CRKSCRW FT 4.5X 14MM
• 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: 24752643
• Report Number: 1220246-2026-01761
• Device Sequence Number: 13333496
• Product Code: MAI
• UDI-Device Identifier: 00888867023376
• UDI-Public: (01)00888867023376(11)250317(17)290228(10)15405124
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K082810
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 05/05/2026

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-COMPSI CRKSCRW FT 4.5X 14MM
• Device Catalogue Number: AR-1927BCF-45
• Device Lot Number: 15405124
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/12/2026
• Supplement Date Received by Manufacturer: 05/04/2026
• Initial Report FDA Received Date: 04/01/2026
• Supplement Report FDA Received Date: 05/05/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/17/2025
• 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