MAUDE Adverse Event Report: ARTHREX, INC. BIO-COMP CRKSCRW FT VENTD 5.5X14.7MM; BIO SOFT TISSUE FIXATN FASTNR

Model Number	BIO-COMP CRKSCRW FT VENTD 5.5X14.7MM
Medical Device Problem Codes	Break (1069); Fracture (1260)
Health Effect - Clinical Codes	Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/12/2025
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 8/4/2025, it was reported by an arthrex subsidiary employee via email that an ar-1927bcft biocomposite corkscrew fractured.During the procedure, standard protocol was followed: after establishing the vision portals, placement of the 5.5 mm implant was initiated.The starter punch was passed and hammered until the first laser line marked ¿ft¿ was reached.Upon placement and two turns of the implant, fracture of the screw was observed.Attempts were made to either complete insertion or retrieve the tip of the screw; however, the fracture prevented further movement in any direction.This was discovered during a procedure on (b)(6) 2025.Additional information was received on 08/13/2025: all screw fragments were retrieved.No documentation was available regarding the case completion details or the part number used.Additionally, there was no information indicating any procedural delay or administration of additional anesthesia.
Additional Manufacturer Narrative
Additional information: g3, h3, h6.Complaint allegation is not confirmed.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 method of bone preparation and the quality of the bone encountered were not specified.The most likely cause of the reported failure can be attributed to user error of the device due to improper bone preparation, misalignment insertion, and/or prying/leveraging of the device during insertion.

• Brand Name: BIO-COMP CRKSCRW FT VENTD 5.5X14.7MM
• 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: 22883425
• Report Number: 1220246-2025-03614
• Device Sequence Number: 8861342
• Product Code: MAI
• UDI-Device Identifier: 00888867023390
• UDI-Public: (01)00888867023390(11)240819(17)280731(10)15303851
• Combination Product (Y/N): N
• Initial Reporter Country: CO
• 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): 10/30/2025

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-COMP CRKSCRW FT VENTD 5.5X14.7MM
• Device Catalogue Number: AR-1927BCFT
• Device Lot Number: 15303851
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 08/04/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/04/2025
• Supplement Date Received by Manufacturer: 10/23/2025
• Initial Report FDA Received Date: 08/25/2025
• Supplement Report FDA Received Date: 10/30/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/19/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown