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

Model Number	SUTURE ANCHOR, MICRO CORKSCREW FT
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	08/04/2021
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 hand ligament repair, the first screw was disconnected from the screwdriver and could not be used.After inserting the second screw into the bone hole, the suture broke when the suture was ligated.Additional information requested.Additional information provided 08/11/2021: the screw and the suture are pulled together and broke from the joint.All fragments were removed.The case was completed by creating a bone tunnel that penetrates the fixation part and fix it with nylon thread.
Additional Manufacturer Narrative
Complaint confirmed.Two unpackaged ar-1318ft-40 suture anchor were returned.Visual evaluation did not showed any damaged to both driver tips.One of the sutures was found to be frayed and broken.The anchor was not returned.Other suture was undamaged and attached to the anchor, but not to the driver.The cause of this event is undetermined; however, a most likely cause is the user-applied excessive mechanical forces.

• Brand Name: SUTURE ANCHOR, MICRO CORKSCREW FT
• Common Device Name: SCREW, FIXATION, BONE
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• MDR Report Key: 12362374
• Report Number: 1220246-2021-03555
• Device Sequence Number: 16955392
• Product Code: HWC
• UDI-Device Identifier: 00888867008526
• UDI-Public: 00888867008526
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K112237
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 10/19/2021

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: SUTURE ANCHOR, MICRO CORKSCREW FT
• Device Catalogue Number: AR-1318FT-40
• Device Lot Number: 10278405
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 08/06/2021
• Supplement Date Received by Manufacturer: 08/06/2021
• Initial Report FDA Received Date: 08/24/2021
• Supplement Report FDA Received Date: 10/19/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1