MAUDE Adverse Event Report: ARTHREX, INC. CLAVICLE FRACTURE PLATE, CENTRAL THIRD, RIGHT, STAINLESS STEEL; WASHER, BOLT, NUT

Catalog Number	AR-2653CR
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	06/08/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Patient demographics (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.The device was requested for evaluation but was not returned 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.Per product directions for use (dfu-0192), post-operatively, 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 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.Facility turned device over to patient.
Event or Problem Description
It was reported that the plate broke 5 1/2 months after insertion and needed to be revised.Initial surgery on (b)(6) 2016.Revision surgery was on (b)(6) 2017.A plate from another manufacturer was used during revision surgery along with a bone graft.Patient is (b)(6) with pseudo-arthrosis.

• Brand Name: CLAVICLE FRACTURE PLATE, CENTRAL THIRD, RIGHT, STAINLESS STEEL
• Common Device Name: WASHER, BOLT, NUT
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• MDR Report Key: 6676501
• Report Number: 1220246-2017-00239
• Device Sequence Number: 1973078
• Product Code: HTN
• UDI-Device Identifier: 00888867027459
• UDI-Public: 00888867027459
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K112437
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• 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): 06/29/2017

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-2653CR
• Device Lot Number: 6791523
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/09/2017
• Initial Report FDA Received Date: 06/29/2017
• 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: 77 YR