FDA Adverse Event Malfunction Summary report: N

DEVICE FOR NAIL FIXATION

MDR report key: 3022900 · Received March 20, 2013

Report

Report Number: 9615741-2013-00012
Event Type: Malfunction
Date Received: March 20, 2013
Date of Event: March 8, 2013
Report Date: March 20, 2013
Manufacturer: NEWDEAL SAS
Product Code: LXH
PMA / PMN Number: K091788
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: AS
Reporter Occupation: OTHER

Narratives

Additional Manufacturer Narrative · 1

TO DATE, THE DEVICE INVOLVED IN THE REPORTED INCIDENT HAS NOT BEEN REC'D FOR EVAL. AN INVESTIGATION HAS BEEN INITIATED BASED ON THE REPORTED INFO.

Description of Event or Problem · 1

THE RPTR NOTED: "DURING A REVISION SURGERY (OF A PREVIOUSLY FAILED ANKLE FUSION), THE PANTA SUPPORT DEVICE WAS ATTACHED TO THE NAIL AS PER SURGICAL TECHNIQUE. THE SURGEON UNINTENTIONALLY HAD THE DEVICE UPSIDE DOWN AS IT WAS INTRODUCED INTO THE MEDULLARY CANAL OVER THE GUIDE WIRE WHICH WAS LEFT IN-SITU. THE SURGEON FELT RESISTANCE AND IMPACTED THE BASE OF DEVICE WITH A MALLET. THE SURGEON HADN'T REALIZED THE DEVICE WAS UNDER THE RESISTANCE AS THE L SHAPE PART WHERE THE CALCANEAL SCREWS ARE PLACED WAS HARD UP - AGAINST THE SOLE OF THE FOOT AND AS THE DEVICE WAS BEING IMPACTED THE DEVICE BROKE AT THE NAIL CONNECTION AT BASE WHERE THE METAL MEETS PLASTIC. THE SURGEON WAS ABLE TO HOLD THE 2 BROKEN PIECES TOGETHER AND COMPLETE THE OPERATION SUCCESSFULLY. THE OUTCOME OF THE SURGERY WAS SATISFACTORY AND NO COMPLICATIONS OCCURRED BECAUSE THE FAILURE OF THE SUPPORT DEVICE."

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
115325	DEVICE FOR NAIL FIXATION	PANTA NAIL	LXH	NEWDEAL SAS		E7D8

Patients

Seq	Age	Sex	Outcome	Treatment
1