ETHIBOND EXTRA & EXCEL POLYESTER SUTURE

Description of Event or Problem

IT WAS REPORTED THAT A PATIENT UNDERWENT A LEFT QUADRICEPS TENDON REPAIR PROCEDURE ON (B)(6) 2012 AND SUTURE WAS USED. THE NEEDLE BROKE AT THE TIP AS THE SURGEON INTRODUCED IT INTO THE VASTUS MEDIALIS TENDON. AN X-RAY WAS DONE AND THE NEEDLE TIP WAS VISUALIZED. IT WAS WELL WITHIN THE TENDON AND SURGEON FELT THAT IT WAS BETTER TO LEAVE THE VERY SMALL FRAGMENT THAN TO TRAUMATIZE THE TENDON FURTHER BY SEARCHING FOR IT.

Additional Manufacturer Narrative

(B)(4). CONCLUSION: THE PRODUCT UPON WHICH THIS MEDWATCH IS BASED IS ANTICIPATED. ONCE THE PRODUCT IS RECEIVED, ANY FURTHER INFORMATION DERIVED FROM THE EVALUATION WILL BE SUBMITTED IN A SUPPLEMENTAL 3500A FORM.

Additional Manufacturer Narrative

CONCLUSION: THE ACTUAL DEVICE INVOLVED IN THIS EVENT WAS RETURNED FOR EVALUATION. THE DEVICE WAS VISUALLY EVALUATED. THERE WERE INDENTS AND SCUFF MARKS AROUND THE BREAK AREA PRODUCED DURING HANDLING BY A SURGICAL NEEDLE HOLDERS OR SOME OTHER GRIPPING DEVICE. THE NEEDLES FRACTURED DUE TO TENSILE OVERLOAD GENERATED DURING SEVERE MECHANICAL DEFORMATION, WITH SIGNS OF DUCTILE FAILURE. THERE WERE NO SIGNS OF MANUFACTURING DEFECTS FOUND ON THE NEEDLE. IN ADDITION, A REVIEW OF THE BATCH MANUFACTURING RECORDS WAS CONDUCTED AND THE BATCH MET ALL FINISHED GOODS RELEASE CRITERIA.