MAUDE Adverse Event Report: ARTHREX, INC. 4.75MM BC KNOTLESS SWIVELOCK W/ TAPE; FASTENER, FIXATION, BIODEGRADABLE, SOFT TISSUE

Model Number	4.75MM BC KNOTLESS SWIVELOCK W/ TAPE
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/01/2020
Type of Reportable Event	Serious Injury
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 that during a rotator cuff repair procedure the surgeon experienced the following issues with arthrex devices, when inserting an ar-2324kbcct (lot 10679428) the swivelock was inserted and upon removal of the driver, the portion of the eyelet that contains the knotless mechanism remained in the cannulation of the driver.When inserting an ar-2324kbcctt (lot 10941879) upon final tensioning of the knotless mechanism the portion of the eyelet broke coming up through the screw, resulting in cutting of the suture and removing the peek portion of the eyelet.The distal end of the eyelet that has the fibertapes through them and the screws themselves stayed in the patient from each anchor.An ar-1922p green punch had been used to prep the bone for insertion.Bone quality of the patient was reported to be good.The reporter states the patient was not harmed in any way and the speedbridge was completed per technique guide with two 5.5mm swivelocks laterally.
Additional Manufacturer Narrative
Complaint confirmed.Visual inspection identified that the distal tip of the hex drive shaft had broken off of the ar-2324kbcct swivelock.A blockage was noted along the inner diameter of the cannula, consistent with what was recorded in the event description.Material analysis of the hex driver shaft concluded that the device met all as-received specifications.As such, this event is most likely the result of off-axis insertion, and/or by prying/leveraging the device during insertion.

• Brand Name: 4.75MM BC KNOTLESS SWIVELOCK W/ TAPE
• Common Device Name: FASTENER, FIXATION, BIODEGRADABLE, SOFT TISSUE
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• MDR Report Key: 10546269
• Report Number: 1220246-2020-02171
• Device Sequence Number: 16902342
• Product Code: MAI
• UDI-Device Identifier: 10888867351124
• UDI-Public: 10888867351124
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K193503
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 09/17/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 02/29/2024
• Device Model Number: 4.75MM BC KNOTLESS SWIVELOCK W/ TAPE
• Device Catalogue Number: AR-2324KBCCT
• Device Lot Number: 10679428
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 09/02/2020
• Supplement Date Received by Manufacturer: 09/02/2020
• Initial Report FDA Received Date: 09/17/2020
• Supplement Report FDA Received Date: 09/17/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other