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

Catalog Number	AR-2257
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	06/27/2014
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
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.The contribution of the device to the reported event could not be determined as the device was not returned for evaluation therefore the complainant's event could not be verified.The cause of the event could not be determined from the information available and without device evaluation.Device history record review revealed nothing relevant to this event.This is the first complaint of this type for this part/lot combination.The potential cause(s) of this event will be communicated to the event reporter.If additional relevant information is received, a follow-up report will be submitted.Unknown device disposition.
Event or Problem Description
It was reported that patient had sustained a right shoulder grade 2-3 acromioclavicular (ac) separation on (b)(6) 2014 during a motorcycle accident.Patient underwent an open reduction, tightrope fixation right acromioclavicular (ac) joint procedure on (b)(6) 2014.At patient's first post-operative visit on (b)(6) 2014, displacement of his previously reduced ac joint was noted.Patient underwent a right shoulder ac joint open reduction and hardware revision with conoid ligament repair on (b)(6) 2014.The op report notes that intraoperative findings found the tightrope was still well positioned but that there was evidence of suture failure at the dorsal button.Revision op report notes the dorsal button was removed.The coracoid button was noted to be well scarred in and not palpable.Visualization under fluoroscopy found the button position to be unchanged.Op report does not indicate that this button was removed.The revision procedure was completed using a tightrope device.

• Brand Name: AC TIGHTROPE RAPAIR KIT
• Common Device Name: WASHER, BOLT NUT
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• MDR Report Key: 5778275
• Report Number: 1220246-2016-00284
• Device Sequence Number: 13499060
• Product Code: HTN
• UDI-Device Identifier: 00888867026391
• UDI-Public: 00888867026391
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: K052776
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2014
• Device Explanted Year: 2014
• Reporter Type: Manufacturer
• Report Source: other
• Initial Reporter Occupation: Attorney
• Type of Report: Initial
• Report Date (Section B): 06/14/2016

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: 02/01/2018
• Device Catalogue Number: AR-2257
• Device Lot Number: 10529
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/14/2016
• Initial Report FDA Received Date: 07/08/2016
• 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
• Patient Age: 35 YR