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

Catalog Number AR-2257

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem Pain (1994)

Event Date 09/15/2017

Event Type  Injury  

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 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
• 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, adverse events ; 1370 creekside boulevard; naples, FL 34108-1945 ; 8009337013
• MDR Report Key: 7273910
• MDR Text Key: 100197601
• Report Number: 1220246-2018-00043
• Device Sequence Number: 1
• Product Code: HTN
• UDI-Device Identifier: 00888867026391
• UDI-Public: 00888867026391
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K052776
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Medical Equipment Company Technician/Representative
• Type of Report: Initial
• Report Date: 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
• Device Operator: Health Professional
• Device Catalogue Number: AR-2257
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 01/24/2018
• Initial Date FDA Received: 02/15/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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