MAUDE Adverse Event Report: ARTHREX, INC. 3.9MM KNOTLESS CORKSCREW, PEEK; FASTENER, FIXATION, NON-DEGRADABLE, SOFT TISSUE

Model Number	3.9MM KNOTLESS CORKSCREW, PEEK
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	04/08/2021
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.
Event or Problem Description
It was reported after the knotless suturetak malfunctioned, the surgeon decided to upsize to the ar-1941ps 3.9 knotless corkscrew to finish that portion of the repair.The surgeon used the ar-1941d to dilate the socket, but the anchor broke immediately upon insertion.The surgeon was able to pick out the loose pieces using a grasper and a shaver.No piece from the unsuccessful anchor was left in the patient.

• Brand Name: 3.9MM KNOTLESS CORKSCREW, PEEK
• Common Device Name: FASTENER, FIXATION, NON-DEGRADABLE, SOFT TISSUE
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• MDR Report Key: 11730921
• Report Number: 1220246-2021-02965
• Device Sequence Number: 14382976
• Product Code: MAI
• UDI-Device Identifier: 00888867270794
• UDI-Public: 00888867270794
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• PMA/510(K) Number: K193157
• 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
• Report Date (Section B): 04/27/2021

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: 3.9MM KNOTLESS CORKSCREW, PEEK
• Device Catalogue Number: AR-1941PS
• Device Lot Number: 10654312
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/08/2021
• Initial Report FDA Received Date: 04/27/2021
• Patient Sequence Number: 1