MAUDE Adverse Event Report: ARTHREX, INC. SUTURE ANCHOR, CORKSCREW FT; SCREW, FIXATION, BONE

Model Number	SUTURE ANCHOR, CORKSCREW FT
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	10/07/2022
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
It was reported that during a surgery an issue with the reported device occurred.It was further reported that something broke off inside the patient.The broken pieces remained inside the patient.There was no harm for patient, operator or third party reported.The surgery was finished successfully with the same device anyway.It was not necessary to switch the surgical technique or do a second surgery.
Additional Manufacturer Narrative
Complaint is confirmed.Visual evaluation noted that the tip at the distal end of the shaft was broken.No broken piece was returned.Also, the assy, anchor/suture, and handle lid were not returned.Functional testing was not performed due to the damage to the device.The most likely cause usually is the excessive force used to pry and/or leverage the device.

• Brand Name: SUTURE ANCHOR, CORKSCREW FT
• Common Device Name: SCREW, FIXATION, BONE
• 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: 16361801
• Report Number: 1220246-2023-06280
• Device Sequence Number: 12577578
• Product Code: HWC
• UDI-Device Identifier: 00888867022614
• UDI-Public: 00888867022614
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K061863
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/03/2023

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: 01/31/2026
• Device Model Number: SUTURE ANCHOR, CORKSCREW FT
• Device Catalogue Number: AR-1915FT-1
• Device Lot Number: 12693283
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/26/2023
• Supplement Date Received by Manufacturer: 01/26/2023
• Initial Report FDA Received Date: 02/13/2023
• Supplement Report FDA Received Date: 08/03/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/09/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown