MAUDE Adverse Event Report: ARTHREX INC. AC TIGHTROPE REPAIR KIT, TITANIUM; WASHER, BOLT NUT

Catalog Number	AR-2257
Health Effect - Clinical Code	Pain (1994)
Date of Event	09/15/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Patient demographics (age at time of event, date of birth, gender, weight) were requested but not provided.No further patient information was provided at the time of this report or made available in response to follow-up communication.No additional adverse consequences have been reported from this event.This device is used for treatment.Lot number was not provided so device history record review cannot be performed.The contribution of the device to the reported event could not be determined as the device was not returned for evaluation.The cause of the event could not be determined from the information available and without device evaluation.The potential causes of this event are being communicated to the event reporter.If additional relevant information is received, a follow-up report will be submitted.
Event or Problem Description
It was reported that the patient had the first surgery in (b)(6).On the first surgery an ar-2257 was implanted.Post-op, the patient complained about pain in the shoulder and went to a different hospital in (b)(6).The surgeon decided on a 2nd surgery and removed the implanted button.The surgeon did not implant a new device.After the 2nd surgery the patient first felt better but now complains again about shoulder pains.

• Brand Name: AC TIGHTROPE REPAIR KIT, TITANIUM
• Common Device Name: WASHER, BOLT NUT
• Manufacturer (Section D): ARTHREX INC.; 1370 creekside boulevard; naples FL 34108 1945
• MDR Report Key: 7273910
• Report Number: 1220246-2018-00043
• Device Sequence Number: 135566
• Product Code: HTN
• UDI-Device Identifier: 00888867026391
• UDI-Public: 00888867026391
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K052776
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Medical Equipment Company Technician/Representative
• Type of Report: Initial
• Report Date (Section B): 02/15/2018

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 Catalogue Number: AR-2257
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/24/2018
• Initial Report FDA Received Date: 02/15/2018
• 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