UNKNOWN_INSTRUMENTSTIRE_PRODUCT
Received Sep 23, 2014 · Event occurred Aug 27, 2014
Report 0001811755-2014-03328 · MDR key 4110456
Device
Product problems
- Break
Patient
Not reported
- No Patient Involvement
Narrative
Additional Manufacturer Narrative
THE DEVICE WAS NOT RETURNED TO STRYKER INSTRUMENTS IRELAND. THE QUALITY INVESTIGATION IS COMPLETE. DEVICE NOT RETURNED TO MANUFACTURER.
Description of Event or Problem
IT WAS REPORTED THAT DURING SERVICE CONDUCTED AT THE MANUFACTURER THE BUR BROKE OFF IN THE DRIVESHAFT. THERE WAS NO DELAY AND NO ADVERSE CONSEQUENCES AS A RESULT OF THIS EVENT.
Additional Manufacturer Narrative
THE DEVICE HAS BEEN RETURNED. A FOLLOW UP REPORT WILL BE FILED ONCE THE QUALITY INVESTIGATION IS COMPLETE.
Description of Event or Problem
IT WAS REPORTED THAT DURING SERVICE CONDUCTED AT THE MANUFACTURER, THE BUR BROKE OFF IN THE DRIVESHAFT. THERE WAS NO DELAY AND NO ADVERSE CONSEQUENCES AS A RESULT OF THIS EVENT.