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	Foreign Body In Patient (2687)
Date of Event	11/11/2024
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 11/11/2024, it was reported by a sales representative via phone that an ar-1927bcf-3 biocomposite corkscrew ft suture anchor, when inserted, was noticed that the tails were cut from the anchor.All sutures to anchor were removed.Then, another ar-1927bcf-3 biocomposite corkscrew ft suture anchor was inserted and broke into two pieces during the insertion.All two pieces of the corkscrew and all sutures were removed from the patient.The case was completed with another ar-1927bcf-3 biocomposite corkscrew ft suture anchor from a different lot with no issues.The case was delayed 20 minutes due to the issue.This was discovered during a rotator cuff repair procedure on (b)(6) 2024, with no reported patient harm.
Additional Manufacturer Narrative
Based on the information provided which may include the device (if available and returned), pictures, videos, event description, and any additional information from the field, arthrex was able to conclude a most likely cause.The most likely cause for the reported failure can be attributed to user error of the device due to excessive force being used during insertion of the implant.

• 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: 20864499
• Report Number: 1220246-2024-08740
• Device Sequence Number: 8838454
• Product Code: MAI
• UDI-Device Identifier: 00888867023369
• UDI-Public: (01)00888867023369(11)240213(17)280131(10)15206196
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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): 07/08/2025

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-COMPOSITE CRKSCRW 5.5X14.9MM
• Device Catalogue Number: AR-1927BCF-3
• Device Lot Number: 15206196
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/11/2024
• Supplement Date Received by Manufacturer: 06/12/2025
• Initial Report FDA Received Date: 12/06/2024
• Supplement Report FDA Received Date: 07/08/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/13/2024
• 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