MAUDE Adverse Event Report: ARTHREX, INC. CORKSCREW FT, BC, SUTURETAPE, 4.75MM; BIO SOFT TISSUE FIXATN FASTNR

Model Number	CORKSCREW FT, BC, SUTURETAPE, 4.75MM
Medical Device Problem Codes	Break (1069); Crack (1135)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/05/2024
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 (b)(6) 2024, it was reported by a sales representative via email that an ar-1927bct-475 biocomposite corkscrew ft was cracked and broke.This was discovered during a procedure on (b)(6) 2024.
Additional Manufacturer Narrative
Additional information was received on 11/21/2024: the screw was not noticeably cracked when out of the box.The screw began to crack upon insertion however it was noticed prior to any fragments breaking off in the shoulder.The case was completed still using a corkscrew anchor overpunched with a larger punch to help with ease of insertion.The case went smooth and was time under anesthetic was not affected, nor was the patient.
Event or Problem Description
Additional information was received on 11/21/2024: the screw was not noticeably cracked when out of the box.The screw began to crack upon insertion however it was noticed prior to any fragments breaking off in the shoulder.The case was completed still using a corkscrew anchor overpunched with a larger punch to help with ease of insertion.The case went smooth and was time under anesthetic was not affected, nor was the patient.
Additional Manufacturer Narrative
Additional information: g3, h3, h6 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: CORKSCREW FT, BC, SUTURETAPE, 4.75MM
• 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: 20789700
• Report Number: 1220246-2024-08645
• Device Sequence Number: 18113678
• Product Code: MAI
• UDI-Device Identifier: 00888867237858
• UDI-Public: (01)00888867237858(11)240521(17)280430(10)15251759
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: K173788
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/09/2025

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: CORKSCREW FT, BC, SUTURETAPE, 4.75MM
• Device Catalogue Number: AR-1927BCT-475
• Device Lot Number: 15251759
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/08/2024
• Supplement Date Received by Manufacturer: 11/21/2024; 06/12/2025
• Initial Report FDA Received Date: 11/26/2024
• Supplement Report FDA Received Date: 12/17/2024; 07/09/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/21/2024
• 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