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	Insufficient Information (4580)
Date of Event	04/03/2024
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 04/11/2024, it was reported by a sales representative via email that two ar-1927pst-475 peek corkscrew ft anchors broke during insertion.The surgeon did not tap.This was discovered during a procedure on (b)(6) 2024.
Additional Manufacturer Narrative
This report is being submitted to provide additional information in h3, h6: type of investigation, investigation findings, investigation conclusions, and h10.Investigation summary: complaint allegation is confirmed.One unpackaged, ar-1927pst-475, batch 15213971, was received for investigation.Visual evaluation confirms that the anchor is detached from the device and is broken.Functional testing couldn't be performed due to the damage of the device.The most likely cause for the reported failure can be attributed to user error due to user-applied excessive mechanical force.As well as improper bone preparation.

• 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: jared engle ; 8009337001
• MDR Report Key: 19239967
• Report Number: 1220246-2024-02773
• Device Sequence Number: 20575028
• Product Code: HWC
• UDI-Device Identifier: 00888867237872
• UDI-Public: 00888867237872
• Combination Product (Y/N): N
• Initial Reporter State: AR
• 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
• Report Date (Section B): 06/27/2024

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 Model Number: CORKSCREW FT, PEEK, SUTURETAPE, 4.75M
• Device Catalogue Number: AR-1927PST-475
• Device Lot Number: 15213971
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/11/2024
• Supplement Date Received by Manufacturer: 06/20/2024
• Initial Report FDA Received Date: 05/03/2024
• Supplement Report FDA Received Date: 06/27/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/29/2024
• 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