QUILL SRS

Report

Report Number: 2522801-2010-00025
Event Type: Other
Date Received: August 19, 2010
Date of Event: July 1, 2010
Report Date: August 23, 2010
Manufacturer: SURGICAL SPECIALTIES CORPORATION (DBA ANGIOTECH)
Product Code: NEW
PMA / PMN Number: K051609
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Location: NJ, US
Reporter Occupation: PHYSICIAN

Narratives

Additional Manufacturer Narrative · 1

THE DATE OF THIS EVENT IS ESTIMATED. SAMPLES WERE NOT AVAILABLE FOR EVALUATION. THE LOT CODE INFO WAS NOT PROVIDED. THEREFORE, THE EXPIRATION DATE AND MANUFACTURING DATE ARE UNK. ONE (1) OTHER QUILL SRS PRODUCT WAS ALSO REPORTED. THE PRODUCT INFO IS AS FOLLOWS: #2 PDO: MODEL/CATALOG #: UNKNOWN; LOT #: UNKNOWN; EXPIRATION DATE: UNKNOWN; DEVICE MANUFACTURE DATE: UNKNOWN; 510(K): K051609. METHOD: SAMPLES WERE NOT AVAILABLE FOR EVALUATION. FURTHERMORE, WITHOUT THE ITEM/LOT CODE INFO, RELEVANT PORTIONS OF THE DEVICE HISTORY RECORDS (DHR) AND STERILITY RECORDS COULD NOT BE REVIEWED. RESULTS/CONCLUSIONS: SAMPLES WERE NOT AVAILABLE FOR EVALUATION. NO PRODUCT EVALUATION CAN BE PERFORMED. ANGIOTECH REFERENCE: (B)(4). ITEM # RA-1067Q / UNKNOWN, QUILL SRS, 0 PDO / #2 PDO, LOT UNKNOWN / UNKNOWN.

Description of Event or Problem · 1

THE DATE OF THE EVENT IS ESTIMATED. (B)(6) PERFORMED A TOTAL KNEE PROCEDURE USING #1 VICRYL AND QUILL SRS #2 PDO TO CLOSE THE CAPSULE, QUILL SRS 0-PDO TO CLOSE THE SUBCUTICULAR LAYER AND STAPLES FOR SKIN CLOSURE. APPROX 6-8 WEEKS POST PROCEDURE, THE PT PRESENTED WITH A NECROSIS AT THE MIDPOINT OF THE INCISION (APPROX. 2.5CM X 3.5CM). THE SURGEON PERFORMED A DEBRIDEMENT OF THE WOUND AND PLACED THE PT ON A WOUND VAC SYSTEM. PT HAS PROGRESSED WELL.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	QUILL SRS	BARBED SUTURE AND NEEDLE	NEW	SURGICAL SPECIALTIES CORPORATION (DBA ANGIOTECH)	RA-1067Q	UNKNOWN

Patients

Seq	Age	Sex	Outcome	Treatment
1			Required Intervention