INBONE DRILL 6MM STERILE

Description of Event or Problem

IT WAS REPORTED THAT, "DURING THE PROCEDURE, THE DRILL GOT STUCK IN THE CANNULA AND COULD NOT BE REMOVED. FURTHERMORE, THE TRIAL INSERT WAS DAMAGED."

Additional Manufacturer Narrative

BASED ON THE AVAILABLE INFORMATION THE DEVICE WILL NOT BE RETURNED THEREFORE AN EVALUATION OF THE DEVICE CANNOT BE PERFORMED. A REVIEW OF THE DEVICE HISTORY IS NOT POSSIBLE BECAUSE THE LOT NUMBER WAS NOT COMMUNICATED. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, IT WILL BE PROVIDED IN A SUPPLEMENTAL REPORT.

Description of Event or Problem

IT WAS REPORTED THAT "DURING THE PROCEDURE, THE DRILL GOT STUCK IN THE CANNULA AND COULD NOT BE REMOVED. FURTHERMORE, THE TRIAL INSERT WAS DAMAGED." THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO PATIENT INVOLVEMENT OR ADDITIONAL INTERVENTION NEEDED. WITH A REPORTED SURGICAL DELAY OF NO MORE THAN 5 MINUTES.

Additional Manufacturer Narrative

CORRECTION TO D9 (PRODUCT AVAILABLE TO STRYKER). THE REPORTED EVENT COULD NOT BE CONFIRMED SINCE THE DEVICE WAS NOT RETURNED FOR EVALUATION AND NO OTHER EVIDENCE WERE PROVIDED. A DEVICE INSPECTION WAS NOT POSSIBLE SINCE THE AFFECTED DEVICE WAS NOT RETURNED AND NO OTHER EVIDENCE WERE PROVIDED FOR INVESTIGATION. A REVIEW OF THE DEVICE HISTORY WAS NOT POSSIBLE BECAUSE THE LOT NUMBER WAS NOT COMMUNICATED. NO CORRECTIVE ACTIONS ARE REQUIRED AT THIS TIME. A REVIEW OF THE LABELING DID NOT INDICATE ANY ABNORMALITIES. INDICATIONS OF MATERIAL, MANUFACTURING, OR DESIGN RELATED PROBLEMS WERE UNABLE TO BE IDENTIFIED AS THE LOT NUMBER WAS NOT COMMUNICATED. MORE DETAILED INFORMATION ABOUT THE COMPLAINT EVENT AS WELL AS THE AFFECTED DEVICE MUST BE AVAILABLE IN ORDER TO DETERMINE THE ROOT CAUSE OF THE COMPLAINT EVENT. IF THE DEVICE IS RETURNED OR IF ANY ADDITIONAL INFORMATION IS PROVIDED, THE INVESTIGATION WILL BE REASSESSED.