SCRDRIVER ANGL

Additional Manufacturer Narrative

PRODUCT WAS NOT RETURNED AND NO LOT NUMBER WAS PROVIDED, THEREFORE NO INVESTIGATION IS POSSIBLE. BASED ON THE INFORMATION AVAILABLE,AND WITHOUT MATERIAL, NO ROOT CAUSE CAN BE DEFINED; THIS COMPLAINT WILL BE ACCOUNTED FOR AND MONITORED VIA POST MARKET SURVEILLANCE ACTIVITIES. IF ADDITIONAL INFORMATION IS MADE AVAILABLE, THE INVESTIGATION WILL BE UPDATED AS APPLICABLE. THIS COMPLAINT WILL BE RE-OPENED IN CASE MATERIAL IS COMING BACK AND OR FURTHER INFORMATION IS RECEIVED. DEVICE IS NOT EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION. DEVICE USED FOR TREATMENT, NOT DIAGNOSIS. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

Additional Manufacturer Narrative

DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. COMPLAINANT PART IS EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

Description of Event or Problem

THE FUNCTION OF THIS INSTRUMENTAL PIECE CONSISTS OF HOOKING THE IMPLANT AND OPEN IT, DEPLOYING A LITTLE METAL PARTS. THE INSTRUMENTAL DIDN'T WORK PROPERLY, AND THE IMPLANT COULDN'T BE OPENED. THE PATIENT, DESPITE BEING IN THE OPERATING ROOM AND BEING ANESTHETIZED, COULDN'T BE OPERATED BY THE INEFFECTIVENESS OF THE INSTRUMENT. THE PROCEDURE WAS NOT COMPLETED SUCCESSFULLY AND MEDICAL INTERVENTION WAS REQUIRED¿ANOTHER SURGERY WAS NEEDED WITH CORRECT INSTRUMENTATION.

Additional Manufacturer Narrative

PATIENT INFORMATION IS UNKNOWN. EVENT DATE UNKNOWN. (B)(4). IMPLANT AND EXPLANT DATE IS NOT APPLICABLE. COMPLAINANT PART IS NOT EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION. LAST NAME, TELEPHONE NUMBER AND ADDRESS UNKNOWN. DEVICE IS NOT DISTRIBUTED IN THE UNITED STATES, BUT IS SIMILAR TO DEVICE MARKETED IN THE USA. WITHOUT A LOT NUMBER THE DEVICE HISTORY RECORDS REVIEW COULD NOT BE COMPLETED. THE MANUFACTURE DATE IS UNKNOWN. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. THE TEKNON INSPACE HAS NOT FINALLY BEEN IMPLANTED BECAUSE THE SCREWDRIVER MECHANISM WAS IN POOR CONDITION AND IT BROKE. THE DEVICE MAY HAVE CAUSED OR CONTRIBUTED TO A SERIOUS INJURY. DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

Description of Event or Problem

DEVICE REPORT FROM SYNTHES EUROPE REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT THE TEKNON INSPACE HAS NOT FINALLY BEEN IMPLANTED BECAUSE THE SCREWDRIVER MECHANISM WAS IN POOR CONDITION AND IT BROKE. IN THE PACKAGE ONLY WAS 1 UNIT INSTEAD OF 2 AND IT WAS NOT POSSIBLE TO IMPLANT THE INSPACE WITH THE PATIENT ALREADY IN THE OPERATING TABLE AND WITH THE APPROACH TAKEN. THIS IS REPORT 1 OF 1 FOR (B)(4).