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	10/22/2025
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 27th feb 2026, it was reported by an arthrex's employee via an email that for 1 unit of ar-1927bcf-45, 4.5 mm biocomposite-corkscrew® ft suture anchor with one #2 fiberwire® and one tigerwire®, the head end of the anchor broke during insertion.This was detected during a rotator cuff repair surgery on (b)(6) 2025.The procedure was completed successfully by using another new ar-1927bcf-45.There were no patient harm and no secondary procedure needed.
Additional Manufacturer Narrative
Additional information: d9, g3, h3, h6 -complaint allegation is confirmed.-visual inspection revealed that the anchor of the 4.5 mm biocomposite-corkscrew® ft suture anchor with one #2 fiberwire® and one tigerwire®, was fractured/broken and remained assembled within the sutures and shaft.-functional test was not performed due to the damage to the device.Per dfu-0087-eo corkscrew®, pushlock®, and swivelock® suture anchors g.Precautions - 3.Make sure to use the recommended drill bit or punch to create the bone socket.Warnings - 6.Bioabsorbable only: attempting implantation into hard, dense bone and/or drilling/punching smaller diameter holes than recommended may cause failure (breakage) of the implant during insertion.The most likely cause of the reported failure can be attributed to user error of the device due to due to applying excessive mechanical forces upon insertion and/or prying/leveraging during use.

• 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: 24634004
• Report Number: 1220246-2026-01498
• Device Sequence Number: 21071168
• Product Code: MAI
• UDI-Device Identifier: 00888867023376
• UDI-Public: (01)00888867023376(11)250325(17)290228(10)15409632
• 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): 05/21/2026

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-COMPSI CRKSCRW FT 4.5X 14MM
• Device Catalogue Number: AR-1927BCF-45
• Device Lot Number: 15409632
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/27/2026
• Supplement Date Received by Manufacturer: 05/19/2026
• Initial Report FDA Received Date: 03/18/2026
• Supplement Report FDA Received Date: 05/21/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/25/2025
• 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