FDA Adverse Event Malfunction Summary report: N

VICRYL PLUS ANTIBACTERIAL (POLYGLACTIN 910) SUTURE

MDR report key: 3902408 · Received June 30, 2014

Report

Report Number: 2210968-2014-08421
Event Type: Malfunction
Date Received: June 30, 2014
Date of Event: May 26, 2014
Report Date: June 10, 2014
Manufacturer: ETHICON INC.
Product Code: GAM
PMA / PMN Number: K032420
Removal / Correction Number: NA
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: JA
Reporter Occupation: OTHER

Narratives

Additional Manufacturer Narrative · 1

(B)(4). CONCLUSION: TO DATE, THE DEVICE HAS NOT BEEN RETURNED. IF THE PRODUCT IS RETURNED FOR EVALUATION, ANY FURTHER INFO DERIVED FROM THE EVALUATION WILL BE SUBMITTED IN A SUPPLEMENTAL 3500A FORM.

Additional Manufacturer Narrative · 1

CONCLUSION: A NEEDLE THAT BROKE IN THE BODY TOWARDS THE ATTACHMENT END WAS SUBMITTED FOR THIS EVALUATION. A MICROSCOPIC INSPECTION REVEALED INDENTS AND SCUFF MARKS AROUND THE BREAK AREA PRODUCED DURING HANDLING BY THE SURGICAL NEEDLE HOLDERS OR SOME OTHER GRIPPING DEVICE. THE NEEDLE FRACTURED DUE TO TENSILE OVERLOAD GENERATED DURING SEVERE MECHANICAL DEFORMATION, WITH SIGNS OF DUCTILITY.

Additional Manufacturer Narrative · 1

A REVIEW OF THE BATCH MANUFACTURING RECORDS WAS CONDUCTED AND THE BATCH MET ALL FINISHED GOODS RELEASE CRITERIA.

Description of Event or Problem · 1

IT WAS REPORTED THAT A PATIENT UNDERWENT A SURGICAL PROCEDURE ON (B)(6) 2014 AND SUTURE WAS USED. DURING THE PROCEDURE, THE NEEDLE BROKE DURING SUTURING. THE NEEDLE WAS RETRIEVED. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THERE WERE NO ADVERSE PATIENT CONSEQUENCES.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
380695	VICRYL PLUS ANTIBACTERIAL (POLYGLACTIN 910) SUTURE	SUTURE, ABSORBABLE, SYNTHETIC	GAM	ETHICON INC.	UNK	HC2319

Patients

Seq	Age	Sex	Outcome	Treatment
1