FDA Adverse Event Malfunction Summary report: N

STRATAFIX KNOTLESS TISSUE CONTROL DEVICE

MDR report key: 5338032 · Received December 29, 2015

Report

Report Number: 3008845715-2015-00103
Event Type: Malfunction
Date Received: December 29, 2015
Date of Event: December 1, 2015
Report Date: December 28, 2015
Manufacturer: SURGICAL SPECIALTIES PUERTO RICO INC. .
Product Code: NEW
PMA / PMN Number: K130078
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: NJ, US
Reporter Occupation: OTHER

Narratives

Additional Manufacturer Narrative · 1

THE ACTUAL DEVICE WILL NOT BE RETURNED. AT THE TIME OF THIS REPORT NO RESPONSE FROM HE NEEDLE SUPPLIER HAS BEEN RECEIVED. RELEVANT PORTIONS OF THE DEVICE HISTORY RECORD WERE REVIEWED. FINISHED GOOD PRODUCT WAS RECEIVED INTO INVENTORY WITHOUT QUALITY ISSUES. THE PRODUCT FROM THIS FINISHED GOOD LOT AND ALL OF THE COMPONENTS MET SURGICAL SPECIALTIES (B)(6) INC. REQUIREMENTS THROUGHOUT THE INCOMING, MANUFACTURING AND THE FINAL INSPECTION PROCESSES. NO INVENTORY AVAILABLE FOR THE FINISHED GOOD LOT REPORTED. NEEDLE SUPPLIER, WHICH IS OUR CUSTOMER AS WELL, WAS CONTACTED TO VERIFY IF THERE WER ANY QUALITY ISSUES RELATED TO THE NEEDLE BATCH USED IN THE MANUFACTURING OF THE LOT REVIEWED. AT THE TIME OF THIS REPORT NO RESPONSE FORM THE SUPPLIER HAS BEEN RECEIVED. THE NEEDLE SUPPLIER HAS BEEN MADE AWARE OF THIS COMPLAINT FOR A CONTINUED INVESTIGATION.

Description of Event or Problem · 1

IT WAS REPORTED THAT "DURING A LAPAROSCOPIC HERNIA PROCEDURE, THE NEEDLE BROKE MIDWAY DOWN NEEDLE. CASE COMPLETED WITH ANOTHER STRAND OF THE E SAME PRODUCT DOE. THERE WERE N O CONSEQUENCES REPORTED ON ESTRAND WAS DISCARDED." REF PR COMPLAINT #: (B)(4).

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
855418	STRATAFIX KNOTLESS TISSUE CONTROL DEVICE	BARBED MATERIAL / NEEDLES,	NEW	SURGICAL SPECIALTIES PUERTO RICO INC. .	SXPL1B400	MDKM750

Patients

Seq	Age	Sex	Outcome	Treatment
1