MAUDE Adverse Event Report: ARTHREX, INC. DX SWIVELOCK, 3.5 X 13.5 MM; FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE

Model Number	DX SWIVELOCK, 3.5 X 13.5 MM
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	10/23/2018
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 device remains in patient.The cause of the event could not be determined from the information available and without device evaluation.
Event or Problem Description
It was reported that the ar-8979p dx swivelock eyelet disengaged before the anchor was inserted into the bone and became stuck beneath the cortical bone within the canal, and could not be retrieved due to the angle it was stuck at.The rep stated this occurred before the anchor body was inserted into the bone socket.A second ar-8979p was inserted successfully without any issue.The rep stated that the broken eyelet remains seated behind the cortical bone in the ulnar "osseaous" canal.The bone was prepped by using a 3.0 drill from ar-8979ds at the designated depth per the depth guide provided from kit.A single limb of labral tape was inserted along with the anchor to finish the ib construct.The screw was inserted with the driver pre-loaded with the anchor.The rep stated that the bone quality was very hard.Patient; (b)(6) male.

• Brand Name: DX SWIVELOCK, 3.5 X 13.5 MM
• Common Device Name: FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• MDR Report Key: 8065526
• Report Number: 1220246-2018-00740
• Device Sequence Number: 11378358
• Product Code: MBI
• UDI-Device Identifier: 00888867202900
• UDI-Public: 00888867202900
• Combination Product (Y/N): N
• Initial Reporter State: OK
• Initial Reporter Country: US
• PMA/510(K) Number: K150648
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 11/13/2018

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: 01/31/2022
• Device Model Number: DX SWIVELOCK, 3.5 X 13.5 MM
• Device Catalogue Number: AR-8979P
• Device Lot Number: 10113629
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/24/2018
• Initial Report FDA Received Date: 11/13/2018
• 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
• Patient Age: 42 YR
• Patient Weight: 93