SALVATION DRILL BIT 4.5MM TAPERED

Additional Manufacturer Narrative

CORRECTION TO D9 (PRODUCT AVAILABLE TO STRYKER) AND H6(DEVICE CODE ) TO REMOVE 'BREAK' CODE. THE REPORTED EVENT COULD NOT BE CONFIRMED SINCE THE DEVICE WAS NOT RETURNED FOR EVALUATION AND NO OTHER EVIDENCES WERE PROVIDED. AN X-RAY IMAGE WAS PROVIDED THAT DOES APPEAR TO SHOW A TIP OF SOME DRIVER INSIDE THE PATIENT. HOWEVER, NO ASSESSMENT CAN BE MADE BASED ON THE IMAGE ALONE. 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. A REVIEW OF THE DEVICE HISTORY FOR THE REPORTED LOT DID NOT INDICATE ANY ABNORMALITIES. NO CORRECTIVE ACTIONS ARE REQUIRED AT THIS TIME. A REVIEW OF THE LABELING DID NOT INDICATE ANY ABNORMALITIES. NO INDICATIONS OF MATERIAL, MANUFACTURING OR DESIGN RELATED PROBLEMS WERE FOUND DURING THE INVESTIGATION. IF THE DEVICE IS RETURNED OR IF ANY ADDITIONAL INFORMATION IS PROVIDED, THE INVESTIGATION WILL BE REASSESSED.

Description of Event or Problem

IT WAS REPORTED THAT WHILE DRILLING USING THE 4.3/3MM TAPER DRILL FOR A 5MM BOLT THE DRILL TIP SNAPPED ON THE TAPERED AREA WITHIN THE PATIENT. THE DRILL BIT WAS REMOVED AND THE SURGERY CONTINUED AS PLANNED SUCCESSFULLY. AN ADDITIONAL DORSAL INCISION AND CUT NEEDED TO BE CREATED. A SURGICAL DELAY OF 20 MINUTES WAS REPORTED.

Additional Manufacturer Narrative

ANALYSIS RESULTS ARE NOT AVAILABLE AT THE TIME OF THIS REPORT. A FOLLOW-UP REPORT WILL BE SENT WHEN THE ANALYSIS IS COMPLETE.

Description of Event or Problem

IT WAS REPORTED THAT WHILE DRILLING USING THE 4.3/3MM TAPER DRILL FOR A 5MM BOLT THE DRILL TIP SNAPPED ON THE TAPERED AREA WITHIN THE PATIENT. THE DRILL BIT WAS REMOVED AND THE SURGERY CONTINUED AS PLANNED SUCCESSFULLY. AN ADDITIONAL DORSAL INCISION AND CUT NEEDED TO BE CREATED. A SURGICAL DELAY OF 20 MINUTES WAS REPORTED.