MAUDE Adverse Event Report: ARTHREX, INC. CORKSCREW FT, PEEK, SUTURETAPE, 4.75M; BONE FIXATION SCREW/PLATE

Model Number	CORKSCREW FT, PEEK, SUTURETAPE, 4.75M
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/28/2023
Type of Reportable Event	Malfunction
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.
Event or Problem Description
On (b)(6) 2023, it was reported by a sales representative via email that an ar-1927pst-475 peek corkscrew ft anchor broke during insertion.The case was completed using another ar-1927pst-475 peek corkscrew ft.This was discovered during an rcr procedure on (b)(6) 2023.The patient was not harmed.Additional information requested.
Additional Manufacturer Narrative
Additional information: g3, h3, h6.The complaint allegation is confirmed.Based on the image submitted from the field, it is evident that the screw was broken into two pieces.Consequently, 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 misaligned insertion and/or prying and levering the screw during insertion.
Additional Manufacturer Narrative
Correction: d2a.

• Brand Name: CORKSCREW FT, PEEK, SUTURETAPE, 4.75M
• Common Device Name: BONE FIXATION SCREW/PLATE
• 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: emily shafer ; 8009337001
• MDR Report Key: 18551997
• Report Number: 1220246-2024-00427
• Device Sequence Number: 12694641
• Product Code: MBI
• UDI-Device Identifier: 00888867237872
• UDI-Public: 00888867237872
• Combination Product (Y/N): N
• Initial Reporter State: NV
• Initial Reporter Country: US
• PMA/510(K) Number: K061863
• 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,Followup
• Report Date (Section B): 04/03/2025

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, PEEK, SUTURETAPE, 4.75M
• Device Catalogue Number: AR-1927PST-475
• Device Lot Number: 15155738
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/28/2023
• Supplement Date Received by Manufacturer: 03/03/2025; Not provided
• Initial Report FDA Received Date: 01/22/2024
• Supplement Report FDA Received Date: 03/18/2025; 04/03/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/18/2023
• 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