BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SHAFT FOR 90° SCREWDRIVER

    MDR report key: 4443756 · Received January 22, 2015

    Report

    Report Number
    3000270450-2015-10021
    Event Type
    Malfunction
    Date Received
    January 22, 2015
    Date of Event
    January 7, 2015
    Report Date
    January 7, 2015
    Manufacturer
    SYNTHES SELZACH
    Product Code
    HWE
    PMA / PMN Number
    PK082649
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL NARRATIVE: SUBJECT DEVICE HAS BEEN RECEIVED AND IS CURRENTLY IN THE EVALUATION PROCESS. INVESTIGATION IS ONGOING; NO CONCLUSION COULD BE DRAWN. 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 · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. ADDITIONAL PRODUCT CODE: DZI, DZJ. DEVICE IS AN INSTRUMENT AND IS NOT IMPLANTED/EXPLANTED. (B)(6). THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. NO NCRS WERE GENERATED DURING PRODUCTION. REVIEW OF THE DEVICE HISTORY RECORD(S) SHOWED THAT THERE WERE NO ISSUES DURING THE MANUFACTURE OF THE PRODUCT THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Additional Manufacturer Narrative · 1

    ADDITIONAL NARRATIVE: A PRODUCT DEVELOPMENT EVALUATION WAS COMPLETED: COUPLING OF A TURNING HANDLE (03.505.005) WAS POSSIBLE AND REVEALED MINOR (I.E. ABNORMAL) FRICTION, INDICATIVE OF A NON-LUBRICATED DEVICE. WHILE TURNING THE HANDLE (03.505.005) WITHIN THE SCREWDRIVER HANDLE (PART 03.505.004 LOT 8134069), THE DISTAL GEAR COUPLING DID NOT MOVE. IT WAS NOTED THAT THE SCREWDRIVER SHAFT (PART 03.505.003 LOT 8130113) WAS LOOSELY CONNECTED TO THE SCREWDRIVER HANDLE (PART 03.505.004 LOT 8134069); HOWEVER, THE THREADED COUPLING BETWEEN THE HANDLE AND THE SHAFT WAS FOUND TO BE IN GOOD CONDITION, WITH THE PRESENCE OF A CLEAR FLUID (POSSIBLY A LUBRICANT) AT THE COUPLING COLLAR. THE EXTERIOR OF THE SCREWDRIVER SHAFT (PART 03.505.003 LOT 8130113) SHOWED FADED LASER MARKINGS AT THE LOT NUMBER, LOGO AND ¿S¿ IN ¿SWISS,¿ BUT NO CORROSION. THE INNER DRIVE SHAFT WAS MISSING. THE INNER GEAR WAS FOUND TO BE IN GOOD CONDITION WITH A LOT OF CLEAR FLUID AND MINOR DISCOLORATION IN THE COUPLING WHERE THE DRILL SAND SCREWDRIVER BLADES ARE INSERTED. THE COMPLAINT CONDITION IS FOUND TO BE RELATED TO LACK OF PROPER ASSEMBLY AND INDICATIVE BY THE MISSING INNER DRIVE SHAFT. 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 · 1

    DEVICE REPORT FROM SYNTHES (B)(4) REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT AFTER CONNECTING ALL PARTS, THE SCREW DRIVER IS CONNECTED TO A KA VO MACHINE (MOTOR). THE SCREW HOLDER IS NOT ROTATING. PATIENT CONDITION REPORTED AS OKAY. THIS REPORT IS 7 OF 15 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    51560 SHAFT FOR 90° SCREWDRIVER INSTR,SURGICAL,ORTHOPEDIC,AC POWERED MOTOR/ACCESS & ATTACH HWE SYNTHES SELZACH 8130113

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR