MAUDE Adverse Event Report: ARTHREX, INC. H-PLATE; PLATE, FIXATION, BONE

Catalog Number	AR-8942R-M
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	09/27/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
This is the first of four submissions for the same patient event.The others are 1220246-2016-00442 ((b)(6) (b)(4)), 1220246-2016-00443 ((b)(6) (b)(4)) and 1220246-2016-00444 ((b)(6) (b)(4)).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.No device malfunction identified.At this time, it cannot be determined if the device may have caused or contributed to the patient's experience.An evaluation of the device cannot be performed as the device was not returned to arthrex.Additional information has been requested but not made available.Lot number was not provided so device history record review cannot be performed.Per customer device will not be returned.
Event or Problem Description
It was reported via an arthrex website inquiry that a patient with a screw and plate in her ankle needs to have it removed.Surgeon reported to sales rep that a screw is backing out.The original surgery took place (b)(6) 2014 on the right foot by a different surgeon at a different facility.The devices are reported to be an arthrex 6.5 mm cannulated screws and 4.5 cannulated screws with an h-plate and locking screws.Additional information obtained on (b)(6) 2016: revision procedure was performed on (b)(6) 2016 to remove the ar-8942r-m, h-plate ((b)(4 (b)(6))), and the screws, ar-8935-24, lo-pro screw, qty 1 ((b)(6) (b)(4)), ar-8935l-26, locking screw, qty 1 ((b)(6) (b)(6)) and ar-8935l-30, locking screw, qty 2 ((b)(6) (b)(4)).

• Brand Name: H-PLATE
• Common Device Name: PLATE, FIXATION, BONE
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• MDR Report Key: 6039356
• Report Number: 1220246-2016-00441
• Device Sequence Number: 840300
• Product Code: HRS
• UDI-Device Identifier: 00888867052079
• UDI-Public: 00888867052079
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: K052614
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2014
• Device Explanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 09/27/2016

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-8942R-M
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/27/2016
• Initial Report FDA Received Date: 10/19/2016
• 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