MAUDE Adverse Event Report: ARTHREX, INC. CORKSCREW FT, BC, SUTURETAPE, 4.75M; FASTENER, FIXATION, BIODEGRADABLE, SOFT TISSUE

Model Number	CORKSCREW FT, BC, SUTURETAPE, 4.75M
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/19/2023
Type of Reportable Event	Malfunction
Event or Problem Description
On (b)(6) 2023, it was reported, by a distributor via sems.That (2) ar-1927bct-475 biocomposite corkscrew ft anchors broke, while being screwed into the bone hole on the initial turn.This was discovered during a procedure.Additional information requested.
Additional Manufacturer Narrative
The contribution of the device to the reported event could not be determined.As the device was not returned for evaluation.The root cause of the event could not be determined from the information available, and without device evaluation.If the device becomes available for evaluation, a follow-up report will be submitted.
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 screw.

• Brand Name: CORKSCREW FT, BC, SUTURETAPE, 4.75M
• Common Device Name: FASTENER, FIXATION, BIODEGRADABLE, SOFT TISSUE
• 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: vik bajnath ; 8009337001
• MDR Report Key: 16914569
• Report Number: 1220246-2023-06721
• Device Sequence Number: 6554737
• Product Code: MAI
• UDI-Device Identifier: 00888867237858
• UDI-Public: 00888867237858
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K173788
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Distributor
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 10/15/2024

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: 05/31/2026
• Device Model Number: CORKSCREW FT, BC, SUTURETAPE, 4.75M
• Device Catalogue Number: AR-1927BCT-475
• Device Lot Number: 14966867
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/19/2023
• Supplement Date Received by Manufacturer: 10/07/2024
• Initial Report FDA Received Date: 05/11/2023
• Supplement Report FDA Received Date: 10/15/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/02/2022
• 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