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 Code	Break (1069)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	08/08/2024
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 08 august 2024, it was reported by a sales representative via email that an ar-1927bct-475-1 corkscrew ft, bc, suturetape, 4.75mm was reported to have broken while being inserted.This occurred on (b)(6) 2024 in (b)(6) hospital during a rotator cuff repair.The case was completed successfully.The tapes were pulled out, broken pieces removed and replaced a peek 4.75 corkscrew there was case involvement.
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 method used to prepare the bone, as well as the bone quality encountered during the procedure, was not provided.The most likely cause can be attributed to misuse due to improper bone preparation; misaligned insertion, or prying/leveraging the screw during insertion.

• 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: 20126938
• Report Number: 1220246-2024-07341
• Device Sequence Number: 3187795
• Product Code: MAI
• UDI-Device Identifier: 00888867237865
• UDI-Public: 00888867237865
• Combination Product (Y/N): N
• Initial Reporter Country: NZ
• PMA/510(K) Number: K173788
• 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): 09/23/2024

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 Expiration Date: 09/30/2025
• Device Model Number: CORKSCREW FT, BC, SUTURETAPE, 4.75MM
• Device Catalogue Number: AR-1927BCT-475-1
• Device Lot Number: 14333442
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/08/2024
• Supplement Date Received by Manufacturer: 09/16/2024
• Initial Report FDA Received Date: 09/03/2024
• Supplement Report FDA Received Date: 09/23/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/14/2021
• 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