MAUDE Adverse Event Report: ARTHREX INC. VOLAR DISTAL RADIAL PLATE TI NARROW LT 5H; PLATE, FIXATION, BONE

Catalog Number	AR-8916VNL-05
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	01/24/2018
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.Lot number was not provided so device history record review cannot be performed.The event states that the plate broke during rehab.The explanted device was requested for evaluation but was not yet returned.The cause of the event could not be determined from the information available and without device evaluation.The most likely cause of this event is failure to properly follow the post-op rehab protocol.The directions for use states: post-operatively, until healing is complete 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 implant.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 underwent a procedure where the volar distal radius plate was implanted.The distal radius plate broke at the k-wire hole post-surgery while the patient was in rehab.A second surgery was performed to remove the plate.No further details.Follow-up investigation: the same surgeon performed both, the original surgery and the revision surgery.A sonoma wrx-6470-g-s was implanted to replace the broken ar-8916vnl-05.The screws were removed with the plate as well.Patient is a female, (b)(6) and was compliant with all post-op guidelines.

• Brand Name: VOLAR DISTAL RADIAL PLATE TI NARROW LT 5H
• Common Device Name: PLATE, FIXATION, BONE
• Manufacturer (Section D): ARTHREX INC.; 1370 creekside boulevard; naples FL 34108 1945
• MDR Report Key: 7273915
• Report Number: 1220246-2018-00045
• Device Sequence Number: 19110074
• Product Code: HRS
• UDI-Device Identifier: 00888867130876
• UDI-Public: 00888867130876
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K131474
• 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): 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-8916VNL-05
• 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
• Patient Age: 54 YR