FDA Adverse Event Malfunction Summary report: N

STRATAFIX KNOTLESS TISSUE CONTROL DEVICE

MDR report key: 3884189 · Received May 20, 2014

Report

Report Number: 3008845715-2014-00020
Event Type: Malfunction
Date Received: May 20, 2014
Date of Event: April 17, 2014
Report Date: May 19, 2014
Manufacturer: SURGICAL SPECIALTIES PUERTO RICO, INC.
Product Code: NEW
PMA / PMN Number: K051609
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: NJ, US
Reporter Occupation: NOT APPLICABLE

Narratives

Additional Manufacturer Narrative · 1

THE ACTUAL PRODUCT INVOLVED WITH THE INCIDENT REPORTED WILL NOT BE RETURNED. METHOD: THE ACTUAL DEVICE WILL NOT BE RETURNED. RESULTS/CONCLUSIONS: THE ACTUAL DEVICE WILL NOT BE RETURNED. NO PRODUCT EVALUATION CAN BE PERFORMED. WITHOUT THE FINISHED GOOD LOT NUMBER, IT IS NOT CERTAIN IF THERE WERE ANY QUALITY ISSUES RELATED TO THE FINISHED GOOD LOT. HOWEVER, A RECORD REVIEW WAS PERFORMED FOR THE FINISHED GOODS LOTS PURCHASED DURING THE PAST SIX MONTHS FOR THIS ITEM. TWO (2) DEVICE HISTORY RECORDS WERE REVIEWED. THERE WERE NO NON CONFORMANCES ISSUED FOR THESE LOTS. NEEDLE SUPPLIER, WHICH IS OUR CUSTOMER AS WELL, WAS CONTACTED TO VERIFY IF THERE WERE ANY QUALITY ISSUES RELATED TO THE NEEDLE BATCHES USED IN THE MANUFACTURING OF THE LOTS REVIEWED. SUPPLIER CONFIRMED THAT NO NCRS WERE GENERATED AS PART OF THE MANUFACTURING PROCESS OF THE NEEDLE LOTS. FINISHED GOOD PRODUCT WERE RECEIVED INTO INVENTORY WITHOUT QUALITY ISSUES. THE NEEDLE SUPPLIER HAS BEEN MADE AWARE OF THIS COMPLAINT FOR A CONTINUED INVESTIGATION. (B)(4), ITEM NUMBER SXPD2B202, FINISHED GOOD LOT NUMBER UNK.

Description of Event or Problem · 1

THE TIP OF THE NEEDLE BROKE OFF AND WAS FOUND INSIDE THE INCISION ON THE KNEE. (B)(4).

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
298578	STRATAFIX KNOTLESS TISSUE CONTROL DEVICE	BARBED MATERIAL/NEEDLES	NEW	SURGICAL SPECIALTIES PUERTO RICO, INC.	SXPD2B202	UNK

Patients

Seq	Age	Sex	Outcome	Treatment
1	NA