WIRE
Received Dec 20, 2012 · Event occurred Sep 28, 2012
Report 2520274-2012-04264 · MDR key 2882866
Device
Generic name
Wire
Manufacturer
Synthes UsaProduct problems
- Break
- Noise, Audible
Patient
Not reported
- No Code Available
Narrative
Description of Event or Problem
PATIENT HAD A TRIPLE CORONARY ARTERY BYPASS GRAFT PROCEDURE PERFORMED ON (B)(6) 2012. THE SAME DAY, AS THE PATIENT WAS STILL PRESENT AT THE HOSPITAL, THE PATIENT HEARD A POP SOUND AND NOTIFIED MEDICAL STAFF. IT WAS DETERMINED THAT THE PATIENT HAD OPENED BACK UP UNDERNEATH THE STAPLES. PATIENT WAS SLENDER IN SIZE. THE PATIENT RETURNED TO THE OPERATING ROOM ON (B)(6) 2012 AND THE FOUR ZIPFIX AND TWO DOUBLE WIRES THAT HAD BROKEN WERE REMOVED. THE SURGEON REVISED THE PATIENT WITH A COMBINATION OF SINGLE AND DOUBLE WIRES. THIS IS 6 OF 6 REPORTS FOR THIS EVENT.
Additional Manufacturer Narrative
DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. WITHOUT A LOT NUMBER THE DEVICE HISTORY RECORDS REVIEW COULD NOT BE COMPLETED. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED.