MAUDE Adverse Event Report: ARTHREX INC. VOLAR DISTAL RAD PLT TI STD LT 3H; PLATE, FIXATION, BONE

Catalog Number	AR-8916VSL-03
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	02/12/2018
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.Device history record review revealed nothing relevant to this event.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.The potential causes of this event are being communicated to the event reporter.If the device is returned and additional information is obtained, a follow-up report will be submitted.
Event or Problem Description
It was reported that the original procedure was performed (b)(6) 2018.Case: distal radius.Everything went well with the original surgery to the best of the surgeon's knowledge.On (b)(6) 2018, patient had a revision because the plate cracked or bent and the one of more screws were backing out.Surgeon was going to go back in and tighten them down, however, upon screwing them back in; the screws were not holding.The surgeon ended up having to replace the right sided plate and four screws.Follow up information: after a patient fall 4 of the distal screws backed out of the plate resulting in surgeon need to perform a revision on (b)(6) 2018.

• Brand Name: VOLAR DISTAL RAD PLT TI STD LT 3H
• Common Device Name: PLATE, FIXATION, BONE
• Manufacturer (Section D): ARTHREX INC.; 1370 creekside boulevard; naples FL 34108 1945
• MDR Report Key: 7321369
• Report Number: 1220246-2018-00077
• Device Sequence Number: 10790676
• Product Code: HRS
• UDI-Device Identifier: 00888867130999
• UDI-Public: 00888867130999
• Combination Product (Y/N): N
• Initial Reporter State: OR
• 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): 03/07/2018

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-8916VSL-03
• Device Lot Number: 10159177
• 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: 02/13/2018
• Initial Report FDA Received Date: 03/07/2018
• 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