MAUDE Adverse Event Report: ARTHREX, INC. DISTAL CLAVICLE PLATE; WASHER, BOLT NUT

Catalog Number	AR-2657DR
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	08/24/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Patient demographics (age at time of event, date of birth, 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.The device met all material specifications as received.The evaluation revealed the plate is broken diagonally towards one end of the device.Fracture surface is rough with little deformation which is typical in metal mechanical fracture as result of bending stress.Device history record review revealed nothing relevant to this event.The most likely cause(s) of this type of event include patient non-compliance to the post-op protocol or post-op trauma to the surgical site.The directions for use for the device states: post-operatively and until healing is complete, fixation provided by this device should be considered as temporary and may not withstand weight bearing or other unsupported stress.The fixation provided by this device should be protected.The post-operative regimen prescribed by the physician should be strictly followed to avoid adverse stresses applied to the device.This is the secpmd 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.
Event or Problem Description
It was reported that a right, 8 hole, distal clavicle plate, ar-2657dr, was used in a right clavicle fracture procedure on (b)(6) 2016 approximately 2 months after the procedure, the plate was discovered to have broken.It was reported that the patient did not have a trauma or injury post-implantation.The plate and screws were explanted on (b)(6) 2016.No screws were broken.The revision procedure was completed using another product.Patient: female.

• Brand Name: DISTAL CLAVICLE PLATE
• Common Device Name: WASHER, BOLT NUT
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• MDR Report Key: 5983849
• Report Number: 1220246-2016-00402
• Device Sequence Number: 19312047
• Product Code: HTN
• UDI-Device Identifier: 00888867027534
• UDI-Public: 00888867027534
• Combination Product (Y/N): N
• Initial Reporter State: OR
• Initial Reporter Country: US
• PMA/510(K) Number: K112437
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Medical Equipment Company Technician/Representative
• Type of Report: Initial
• Report Date (Section B): 09/07/2016

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 Catalogue Number: AR-2657DR
• Device Lot Number: 6791305
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/26/2016
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/07/2016
• Initial Report FDA Received Date: 09/28/2016
• 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