MAUDE Adverse Event Report: ARTHREX, INC. AC TIGHTROPE, TWIN TAIL; WASHER, BOLT NUT

Model Number	AC TIGHTROPE, TWIN TAIL
Health Effect - Clinical Codes	Fall (1848); Pain (1994); Injury (2348)
Date of Event	12/18/2019
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 about three months ago, the patient suffered an accidental fall and injured his left shoulder.An x-ray showed a dislocation of the left acromioclavicular joint.The patient underwent a surgery for dislocation of the left acromioclavicular joint where a twin tail ac tightrope, ar-2264, was implanted.The shoulder of the patient gradually recovered to normal movement function, and the patient was discharged from the hospital.One month after discharge, the patient followed up for reexamination and an x-ray showed that the button that was implanted with the twin tail ac tightrope, ar-2264, under the coracoid of the left shoulder, had shifted and the acromioclavicular joint was dislocated once again.The patient had no pain in the left shoulder and was able to do normal movement.Follow-up observation was conducted one month ago and the patient felt pain when the left shoulder was performing normal movement; which affected the movement and made no improvement after rest.On (b)(6), the patient was seen again for re-examination, and the x-ray showed: "the button under the coracoid of the left shoulder shifted, and the acromioclavicular joint was completely dislocated".The patient was advised to be in hospital for further diagnosis and treatment.Additional information provided 2/3/2020: status of patient currently is reported as "good condition".Patient had stayed in hospital 3 days post the first surgery.It was not confirmed if this was a planned hospital stay.Customer has indicated a second surgery was needed but at this time there is no information on whether or not one has taken place or been scheduled.There was no arthrex representative present during the procedure.Photos were taken and have been provided to arthrex.Once ar-2264 was used and did not have any issue during the first surgery.Quality of patient's bone at time of procedure was reported to have been medium.No unplanned incisions were needed during the first surgery.Patient was admitted to the hospital a second time which resulted in a 5 day stay.Additional information provide 4/29/2020: the three day hospital stay post the first surgery was planned in advance.The patient underwent a second surgery which was performed on (b)(6) 2019.During the second surgery the ar-2264, lot 10259819 was explanted.Products from another manufacturer were then implanted.The patient was admitted for a 5 day stay post the second surgery which was planned.Additional information provided 4/30/20: the original procedure took place on (b)(6) 2019.

• Brand Name: AC TIGHTROPE, TWIN TAIL
• Common Device Name: WASHER, BOLT NUT
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• MDR Report Key: 10074702
• Report Number: 1220246-2020-01846
• Device Sequence Number: 19558271
• Product Code: HTN
• UDI-Device Identifier: 00888867026513
• UDI-Public: 00888867026513
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K052776
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date (Section B): 05/20/2020

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: 11/30/2023
• Device Model Number: AC TIGHTROPE, TWIN TAIL
• Device Catalogue Number: AR-2264
• Device Lot Number: 10259819
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/29/2020
• Initial Report FDA Received Date: 05/20/2020
• 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