MAUDE Adverse Event Report: ARTHREX, INC. TIGHTROPE, ABS, IMPLANT; PIN, FIXATION, SMOOTH

Model Number TIGHTROPE, ABS, IMPLANT

Device Problems Break (1069); Appropriate Term/Code Not Available (3191)

Patient Problem Injury (2348)

Event Date 08/20/2019

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 root cause of the event could not be determined from the information available and without device evaluation.

Event Description

It was reported that the following clinical event information was provided in a tga closure letter: patient underwent a shoulder surgery on july 1, 2019 using x4 arthrex tightrope abs implants, ar-1588tn, (artg id# (b)(4)).The patient was told by his orthopedic surgeon each one has 1000 newtons strength (102 kg force) being 408 kg force total to break.Patient states he knows everything looked well the morning after surgery because x-rays were taken.After several weeks when he came out of sling he noticed the clavicle still stuck up like before surgery.He went to his general practitioner who sent him for an x-ray on (b)(6) 2019 which showed separation with anchors still properly placed.The patient then saw his orthopedic surgeon who confirmed it looks like the product has failed.The patient has a revision surgery scheduled for replacement of the product.Additional information provided 9/6/2019- the revision surgery is scheduled for (b)(6) 2019.The dogbone under the clavicle will remain in the patient as it is too dangerous to remove.The patient did not suffer any kind of post-op trauma.Additional information provided 1/7/2020- the product specialist spoke to the hospital and was able to be confirm that the revision surgery was carried out on (b)(6) 2019.She stated that she is aware of 2 x tightropes and 1 x dogbone being explanted but was unsure of the second dogbone.Unfortunately these devices are not available to be returned as they have been discarded by the hospital.

• Brand Name: TIGHTROPE, ABS, IMPLANT
• Type of Device: PIN, FIXATION, SMOOTH
• 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: 9631335
• MDR Text Key: 190498017
• Report Number: 1220246-2020-01597
• Device Sequence Number: 1
• Product Code: HTY
• UDI-Device Identifier: 00888867019706
• UDI-Public: 00888867019706
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K110123
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 01/27/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/27/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 02/29/2024
• Device Model Number: TIGHTROPE, ABS, IMPLANT
• Device Catalogue Number: AR-1588TN
• Device Lot Number: 10287066
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/07/2020
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 03/18/2019
• 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