DEPUY MYTEC VAPR S90 WAND
Received Dec 17, 2020 · Event occurred Oct 15, 2020
Report 3032391-2020-00013 · MDR key 11027315
Device
Product problems
- Break
Patient
Not reported
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
PER MEDWATCH REPORT MW5097327 IT WAS REPORTED THAT THE TIP OF THE REPROCESSED DEPUY MYTEC VAPR S90 WAND BROKE OFF INTRAOPERATIVELY DURING A HIP BURSECTOMY PROCEDURE. THERE WAS NO CUSTOMER CONTACT INFORMATION PROVIDED IN THE MEDWATCH THAT THE MANUFACTURER RECEIVED FROM THE FDA TO FOLLOW UP WITH THE CUSTOMER, THEREFORE NO ADDITIONAL INFORMATION IS AVAILABLE TO BE OBTAINED. DUE TO THE REPORTED INCIDENT AND IN AN ABUNDANCE OF CAUTION, THIS MEDWATCH IS BEING FILED. IF ADDITIONAL RELEVANT INFORMATION BECOMES AVAILABLE A SUPPLEMENTAL MEDWATCH WILL BE FILED.
Description of Event or Problem
THE TIP OF THE WAND BROKE OFF INTRAOPERATIVELY.