QUILL SRS

Report

Report Number: 2522801-2012-00010
Event Type: Other
Date Received: July 26, 2012
Date of Event: July 3, 2012
Report Date: July 26, 2012
Manufacturer: SURGICAL SPECIALTIES CORP. (DBA ANGIOTECH)
Product Code: NEW
PMA / PMN Number: K051609
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Location: PA, US
Reporter Occupation: PHYSICIAN

Narratives

Additional Manufacturer Narrative · 1

NO SAMPLES WERE AVAILABLE FOR EVAL. THEREFORE, NO TESTING WAS PERFORMED. THE LOT CODE INFO WAS NOT PROVIDED. THEREFORE, THE EXP DATES AND MFG DATES ARE UNK. ADD'L ITEM REPORTED BY THIS CUSTOMER: 0, 2-0 MONODERM, MODEL/CAT#: YA-1029Q, YA-2024Q, LOT# : UNK, EXP DATE: UNK, DEVICE MANUFACTURE DATE: UNK, 510 (K)#: K072028. METHOD: THE DEVICES WERE NOT RETURNED FOR REVIEW. NO PRODUCT EVAL WILL BE PERFORMED. RESULTS/CONCLUSION: WITHOUT THE FINISHED GOOD LOT NUMBERS, RELEVANT PORTIONS OF THE DEVICE HISTORY RECORDS AND/OR STERILITY RECORDS COULD NOT BE REVIEWED. HOWEVER, ALL QUILL MEDICAL DEVICES ARE CONFIRMED STERILIZED PRIOR TO BEING RELEASED TO THE FIELD. THE ROOT CAUSE FOR THE POST-OPERATIVE ABSCESS CAN NOT BE DETERMINED AT THIS TIME. (B)(4). ITEM # RA-1065Q, YA-1029Q, YA-2024Q, QUILL SRS DEVICE, #2 PDO, 0 MONODERM, 2-0 MONODERM LOT UNK.

Description of Event or Problem · 1

DR (B)(6) PERFORMED A UNILATERAL PARTIAL KNEE REPLACEMENT UTILIZING QUILL SRS MONODERM AND PDO DEVICES FOR CLOSURE OF THE FACIA, SUBCUTICULAR AND SUBCUTANEOUS LAYERS OF TISSUE. THE PT PRESENTED WITH AN ABSCESS APPROX THREE (3) WEEKS POST OPERATIVELY. THE INCISION WAS REOPENED, IRRIGATED, AND RE-CLOSED AT THE DISTAL AND PROXIMAL ENDS. NO CULTURES AND SENSITIVITIES WERE COMPLETED TO CONFIRM INFECTION.

Devices

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

Patients

Seq	Age	Sex	Outcome	Treatment
1			Required Intervention