MERSILENE POLYESTER FIBER STRIP
Received Aug 15, 2012 · Event occurred Jul 22, 2012
Report 2210968-2012-03973 · MDR key 2699487
Device
Generic name
Suture, Non-absorbable
Manufacturer
Ethicon, Inc.Model number
NACatalog number
W21
Lot number
V2001
Product problems
- Break
Patient
Not reported
- No Consequences Or Impact To Patient
Narrative
Description of Event or Problem
IT WAS REPORTED THAT A PATIENT UNDERWENT A ANTERIOR CRUCIATE LIGAMENT REPAIR PROCEDURE ON (B)(6) 2012 AND SURGICAL TAPE WAS USED. DURING THE PROCEDURE THE TAPE BROKE. THERE WERE NO ADVERSE PATIENT CONSEQUENCES.
Additional Manufacturer Narrative
(B)(4). CONCLUSION: REPRESENTATIVE SAMPLES WERE RETURNED FOR EVALUATION. THEY WERE VISUALLY AND FUNCTIONALLY EXAMINED FOR TENSILE STRENGTH AND THEY MET THE REQUIREMENTS. IN ADDITION, A REVIEW OF THE BATCH MANUFACTURING RECORDS WAS CONDUCTED AND THE BATCH MET ALL FINISHED GOODS RELEASE CRITERIA. THIS IS ONE OF FOUR MEDWATCHES BEING SUBMITTED AS FOUR DEVICES WERE INVOLVED IN THIS EVENT. SEE ALSO MEDWATCH 2210968-2012-03972, MEDWATCH 2210968-2012-03974, AND MEDWATCH 2210968-2012-03975. THE SAME PATIENT IS REPRESENTED IN EACH MEDWATCH.
Remedial action
- Other