QUILL KNOTLESS TISSUE-CLOSURE DEVICE

Report

Report Number: 2522801-2011-00012
Event Type: Injury
Date Received: May 11, 2011
Date of Event: May 1, 2010
Report Date: May 11, 2011
Manufacturer: SURGICAL SPECIALTIES CORP. (DBA ANGIOTECH)
Product Code: NEW
PMA / PMN Number: K051609
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Location: NY, US
Reporter Occupation: PHYSICIAN

Narratives

Additional Manufacturer Narrative · 1

NO SAMPLES WERE AVAILABLE FOR EVAL. THEREFORE, NO TESTING CAN BE PERFORMED. THE ITEM AND LOT CODE INFO WAS NOT PROVIDED. THEREFORE, THE EXPIRATION DATES AND MFG DATES ARE UNK. ADDITIONAL ITEM REPORTED BY THIS CUSTOMER: MONODERM, MODEL/CATALOG #: UNK, LOT #: UNK, EXPIRATION DATE: UNK, DEVICE MFR DATE: UNK, 510(K) #: K072028. METHOD: THE DEVICES WERE NOT AVAILABLE FOR EVAL. NO PRODUCT EVAL CAN BE PERFORMED. RESULTS/CONCLUSION: THE DEVICES WERE NOT RETURNED FOR EVALUATION. NO PRODUCT EVAL CAN BE PERFORMED. WITHOUT THE FINISHED GOOD ITEM/LOT NUMBERS, RELEVANT PORTIONS OF THE DEVICE HISTORY RECORDS COULD NOT BE REVIEWED. IT IS UNCERTAIN IF THE QUILL KNOTLESS TISSUE-CLOSURE DEVICES ATTRIBUTED TO THESE EVENTS. A DEFINITIVE CONCLUSION CANNOT BE DRAWN AT THIS TIME. ANGIOTECH REFERENCE: (B)(4), ITEM # UNK, QUILL KNOTLESS TISSUE-CLOSURE DEVICE, PDO, MONODERM, LOTS UNK.

Description of Event or Problem · 1

THE DATE OF THIS EVENT IS ESTIMATED. AN ANGIOTECH SALES REPRESENTATIVE REPORTED THAT APPROX ONE YEAR AGO, DR. (B)(6) HAD SEVERAL PTS EXPERIENCE WOUND DEHISCENCE FOLLOWING ORTHOPEDIC PROCEDURES WHERE A QUILL PDO OR MONODERM KNOTLESS TISSUE-CLOSURE DEVICE WAS USED. THESE CASES WERE NOT REPORTED AT THE TIME OF OCCURRENCE. CLINICAL DETAILS OF THESE CASES ARE UNK. MULTIPLE ATTEMPTS TO REACH THIS SURGEON HAVE BEEN UNSUCCESSFUL.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	QUILL KNOTLESS TISSUE-CLOSURE DEVICE	PDO BARBED SUTURE/NEEDLE	NEW	SURGICAL SPECIALTIES CORP. (DBA ANGIOTECH)	UNK	UNK

Patients

Seq	Age	Sex	Outcome	Treatment
1			Required Intervention