MAUDE Adverse Event Report: ARTHREX, INC. KNOTLESS T-ROPE SYN-DESMOSIS REPR KIT,SS; WASHER, BOLT NUT

Model Number KNOTLESS T-ROPE SYN-DESMOSIS REPR KIT,SS

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem Pain (1994)

Event Date 08/20/2018

Event Type  Injury  

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 was reported to have been discarded.The cause of the event could not be determined from the information available and without device evaluation.

Event Description

It was reported that the patient underwent a syndesmosis repair on his left ankle where a tightrope was implanted.6-weeks post-op the patient went in for his check up and an x-ray revealed that the tightrope has failed and the bones were beginning to separate again.A few days before his post-op appointment, he was experiencing a sharp pain with every step.The patient is scheduled for a second surgery on (b)(6) 2018 where the surgeon will implant a quantity of two of the same tightrope.Additional information obtained (b)(6) 2018: patient called to report that his revision procedure took place as scheduled on (b)(6) 2018.Patient states surgeon removed one device and implanted two as planned.The explanted part number is still pending.Patient states that he requested that the explanted device be returned to arthrex for evaluation but was informed the device would not hold up under sterilization and the device was reported to have been discarded.Additional information obtained (b)(6) 2018: part number of the arthrex product implanted during the (b)(6) 2018 procedure was ar-8926ss.Lot number not provided.

• Brand Name: KNOTLESS T-ROPE SYN-DESMOSIS REPR KIT,SS
• Type of Device: WASHER, BOLT NUT
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• Manufacturer (Section G): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• Manufacturer Contact: vik bajnath ; 8009337001
• MDR Report Key: 8129893
• MDR Text Key: 129303982
• Report Number: 1220246-2018-00779
• Device Sequence Number: 1
• Product Code: HTN
• UDI-Device Identifier: 00888867049079
• UDI-Public: 00888867049079
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K043248
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,other
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 12/04/2018

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?: No
• Device Operator: Health Professional
• Device Model Number: KNOTLESS T-ROPE SYN-DESMOSIS REPR KIT,SS
• Device Catalogue Number: AR-8926SS
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 11/16/2018
• Initial Date FDA Received: 12/04/2018
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other