QUILL SRS

Report

Report Number: 2522801-2011-00001
Event Type: Other
Date Received: January 5, 2011
Date of Event: December 8, 2010
Report Date: January 5, 2011
Manufacturer: SURGICAL SPECIALTIES CORP. (DBA ANGIOTECH)
Product Code: NEW
PMA / PMN Number: K051609
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Location: TN, US
Reporter Occupation: PHYSICIAN

Narratives

Additional Manufacturer Narrative · 1

NO SAMPLES WERE AVAILABLE FOR EVAL. THEREFORE, NO TESTING CAN BE PERFORMED. THE LOT CODE INFO WAS NOT PROVIDED. THEREFORE, THE EXPIRATION DATES AND MFG DATES ARE UNK. ADDITIONAL ITEMS REPORTED BY THIS CUSTOMER: PDO: MODEL/CATALOG #: RX-1029Q; LOT # UNK; EXP DATE: UNK; DEVICE MFR DATE: UNK; 510K #: K051609. A 2-0 MONODERM; MODEL/CATALOG #: YA-1022Q, LOT #: UNK, EXP DATE: UNK, DEVICE MFR DATE: UNK, 510K #: K072028. METHOD: THE DEVICES WERE NOT AVAILABLE FOR EVAL. NO PRODUCT EVAL CAN BE PERFORMED. RESULTS/CONCLUSION: THE DEVICES WERE NOT RETURNED FOR EVAL. NO PRODUCT EVAL CAN BE PERFORMED. WITHIN THE FINISHED GOOD LOT NUMBERS, RELEVANT PORTIONS OF THE DEVICE HISTORY RECORDS COULD NOT BE REVIEWED. IT IS UNCERTAIN IF THE QUILL SRS MATERIAL ATTRIBUTED TO THIS EVENT. A DEFINITIVE CONCLUSION CANNOT BE DRAWN AT THIS TIME. (B)(4).

Description of Event or Problem · 1

THE DATE OF EVENT IS ESTIMATED. DR (B)(6) REPORTED THREE (3) CASES OF INFECTION FOLLOWING TOTAL HIP PROCEDURE WHERE QUILL SRS PDO AND MONODERM MATERIAL WERE USED. IT IS UNK WHAT SURGICAL TECHNIQUE WAS USED FOR PLACEMENT. IT IS ALSO NOT KNOWN IF OTHER PRODUCTS, SUCH AS STAPLES, WERE USED FOR CLOSURE. NONE OF THE INFECTIONS WERE CONFIRMED BY CULTURES. ALL PTS REQUIRED SURGICAL DEBRIDEMENT OF WOUNDS. VERY LIMITED INFO OBTAINED DUE TO THE INABILITY TO REACH THE SURGEON.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	QUILL SRS	BARBED SUTURE/NEEDLE	NEW	SURGICAL SPECIALTIES CORP. (DBA ANGIOTECH)	RX-1033Q	UNK

Patients

Seq	Age	Sex	Outcome	Treatment
1			Required Intervention