MAUDE Adverse Event Report: ARTHREX, INC. FIBERTAPE TENDON COMPRESSION BRIDGE KIT; SUTURE, NONABSORBABLE, SYNTHETIC, POLYETHYLENE

Model Number	FIBERTAPE® TENDON COMPRESSION BRIDGE KIT
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	07/03/2018
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 is expected but was not returned for evaluation.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 during a total shoulder arthroplasty procedure as the surgeon was attempting to pull the tails of the tape on the ar-7297 fibertape compression bridge kit (that were loaded into the nitinol loop) through the looped ends of the tape, the nitinol loop broke before the ends of tape were passed.The broken black plastic piece and nitnol loop were fully retrieved and tossed from the sterile field.The procedure was completed as planned.The rep stated that the surgeon performs x-rays after every procedure.The x-ray taken revealed a small metal piece remained in the patient.The patient was still under anesthesia and in the operating room.The surgeon reopened the incision and extended by approximately an inch in order to remove the broken fragment.After inspecting the broken metal piece, the rep confirmed that the piece that fell into the incision was the small metal rod within the black plastic piece and nitnol loop.Additional information received 07/10/2018: the rep stated that the procedure was completed by loading the ends of the tape into a free needle, and proceeded to pass the ends through the tape loops.Additional information received 7/26/2018 via facility medwatch (4900240000-2018-8091): foreign body was retrieved with flouro guidance.Routine flat plate films were done at the end of the second procedure.No retained object confirmed.Surgeon notified family before starting foreign body removal procedure and after it was completed.
Additional Manufacturer Narrative
The evaluation revealed the nitinol wire had pulled out of the ferrule.The ferrule met all dimensional specifications as received and displayed deep crimp markings as expected.The nitinol wire was not received with the device, so it could not be determined if the wire placement within the ferrule was correct.The retention dowel displayed tool marks along the shaft consistent with attempts to retrieve the device during surgery.

• Brand Name: FIBERTAPE TENDON COMPRESSION BRIDGE KIT
• Common Device Name: SUTURE, NONABSORBABLE, SYNTHETIC, POLYETHYLENE
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• MDR Report Key: 7734409
• Report Number: 1220246-2018-00574
• Device Sequence Number: 806077
• Product Code: GAT
• UDI-Device Identifier: 00888867289086
• UDI-Public: 00888867289086
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: K122374
• 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): 08/22/2018

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: 04/30/2022
• Device Model Number: FIBERTAPE® TENDON COMPRESSION BRIDGE KIT
• Device Catalogue Number: AR-7297
• Device Lot Number: 10197428
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/09/2018
• Initial Date Received by Manufacturer: 07/10/2018
• Supplement Date Received by Manufacturer: 07/10/2018
• Initial Report FDA Received Date: 07/31/2018
• Supplement Report FDA Received Date: 08/22/2018
• 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