FDA Adverse Event Injury Summary report: N

ARCAD

MDR report key: 6053719 · Received October 25, 2016

Report

Report Number: 3010673777-2016-00003
Event Type: Injury
Date Received: October 25, 2016
Report Date: October 25, 2016
Manufacturer: NOVASSTEP
Product Code: JDR
UDI-DI: 03700879501291
PMA / PMN Number: K142111
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Location: FR
Reporter Occupation: OTHER

Narratives

Additional Manufacturer Narrative · 1

COMPLAINT # (B)(4) OPENED : ALL INVESTIGATION DONE AT THIS TIME CONFIRMED THESE BATCHES OF ARCAD WERE PRODUCED AND CONTROLLED CONFORM TO NOVASTEP SPECIFICATIONS. COMMENT: 2 STAPLES HAVE BEEN USED FOR THIS CASE, WE DON'T KNOW WHICH STAPLE LOT NUMBER HAS BROKEN. FOR INFORMATION, WE ADD IN THIS MDR ALL INFORMATION RELATED THE 2ND STAPLE. MODEL # CATALOG # : CS041618, LOT # : D00213, EXPIRY DATE : 02/01/2016. DEVICE EVALUATED BY MANUFACTURER ? NOT EXPLANTED. DEVICE NOT EXPLANTED.

Description of Event or Problem · 1

DURING A SALES REP VISIT ON (B)(6) 2016 IT WAS REPORTED TO NOVASTEP SALES REP. THAT DURING THE LAST 12 MONTH 3 CASES HAVE CONDUCTED TO ARCAD 18 COMPRESSIVE STAPLE BREAKAGE. THIS IS THE SAME SURGEON FOR THESE 3 CASES. FIRST CASE: ARCAD 18-16-18 COMPRESSIVE STAPLE WAS DETECTED AS BROKEN BY THE SURGEON DURING THE ANALYSIS OF XRAY PERFORMED DURING A PATIENT FOLLOW UP VISIT. THE SURGEON EXPECTS THAT THE USE OF ONLY TWO ARCAD 18 STAPLES TO PROCEED MTP ARTHRODESIS TO BE TOO WEAK. ASSEMBLY SHOULD HAVE BEEN DONE USING BIGGER STAPLES OR ADDITIONAL DEVICES ASSOCIATED WITH TWO ARCAD 18 COMPRESSIVE STAPLES. THE OTHERS 2 CASES HAVE BEEN REPORTED IN REPORT 3010673777-2016-00001, 3010673777-2016-00002.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
705724	ARCAD	STAPLE	JDR	NOVASSTEP	ARCAD	C00684	03700879501291

Patients

Seq	Age	Sex	Outcome	Treatment
1			Other