FDA Adverse Event Other Summary report: N

QUILL SRS

MDR report key: 1658870 · Received April 13, 2010

Report

Report Number: 2522801-2010-00009
Event Type: Other
Date Received: April 13, 2010
Date of Event: March 1, 2010
Report Date: April 13, 2010
Manufacturer: SURGICAL SPECIALTIES CORP. (DBA ANGIOTECH)
Product Code: NEW
PMA / PMN Number: K051609
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Location: CA, US
Reporter Occupation: PHYSICIAN

Narratives

Additional Manufacturer Narrative · 1

THE DATE OF THE EVENT IS ESTIMATED. NO SAMPLES WERE RETURNED TO ANGIOTECH FOR EVALUATION. THE LOT CODE INFO WAS NOT DISCLOSED. THEREFORE, THE EXPIRATION AND MFG DATES ARE UNK. ONE (1) OTHER QUILL SRS PRODUCT WAS ALSO REPORTED. THE PRODUCT INFO IS AS FOLLOWS: #0 PDO: MODEL/CATALOG #: RA-1067Q. LOT#: UNK. EXP DATE: UNK. DEVICE MANUFACTURE DATE: UNK. 510(K)#: K051609. METHOD: THE DEVICES WERE NOT RETURNED FOR EVALUATION. FURTHERMORE, WITHOUT THE LOT CODE INFO, RELEVANT PORTIONS OF THE DEVICE HISTORY RECORDS (DHR) COULD NOT BE REVIEWED. RESULTS/CONCLUSION: THE DEVICES WERE NOT RETURNED FOR EVALUATION. NO PRODUCT EVALUATION CAN BE PERFORMED. ANGIOTECH REF: (B)(4). ITEM # RA-1065Q, QUILL SRS, #2 PDO, LOT UNK. ITEM # RA-1067Q, QUILL SRS, #0 PDO, LOT UNK.

Description of Event or Problem · 1

THE DATE OF THIS EVENT IS ESTIMATED: (B)(6) PERFORMED A TOTAL KNEE ARTHROPLASTY PROCEDURE USING QUILL SRS #2 PDO FOR CAPSULAR CLOSURE, SIZE 0 PDO TO CLOSE THE INTERMEDIATE LAYER AND STAPLES FOR THE SKIN. THE PT PRESENTED ONE (1) WEEK POST OPERATIVE FOR A ROUTINE OFFICE VISIT. THE SURGEON PLACED THE KNEE IN FLEXION AND THE ARTHROTOMY OPENED UP. THE PT'S INCISION WAS RE-CLOSED IN THE PHYSICIAN'S OFFICE.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	QUILL SRS	BARBED SUTURE WITH NEEDLE	NEW	SURGICAL SPECIALTIES CORP. (DBA ANGIOTECH)	RA-1065Q	UNK

Patients

Seq	Age	Sex	Outcome	Treatment
1			Required Intervention