BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HANDLE FOR 90° SCREWDRIVER

    MDR report key: 4439618 · Received January 21, 2015

    Report

    Report Number
    3000270450-2015-10029
    Event Type
    Malfunction
    Date Received
    January 21, 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: A PRODUCT DEVELOPMENT EVALUATION WAS COMPLETED: COUPLING OF A TURNING HANDLE (PART 03.505.005) WAS POSSIBLE AND REVEALED LITTLE TO NO ABNORMAL FRICTION WITHIN THE SCREWDRIVER HANDLE (PART 03.505.004 LOT 8101489); HOWEVER, WHILE TURNING THE HANDLE (03.505.005), IT WAS OBSERVED THAT THE DISTAL END (GEAR COUPLING) DID NOT ROTATE. 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 8101489) AND PROVED DIFFICULT TO FULLY TIGHTEN. UPON DISASSEMBLY, THE THREADED COUPLING BETWEEN THE HANDLE AND SHAFT WAS NOTED TO HAVE MINOR DAMAGE AT THE LEAD IN OF THE THREAD WHICH IS AS A RESULT OF CROSS-THREADING OR DROPPING THE HANDLE (THREAD SIDE DOWN) ON THE GROUND. THE SCREWDRIVER SHAFT EXTERIOR WAS IN GOOD CONDITION. ONCE THE SCREWDRIVER SHAFT (PART 03.505.003 LOT 8130113) WAS DECOUPLED FROM THE HANDLE, IT WAS NOTED THAT THE INNER DRIVE SHAFT WAS MISSING. THE GEAR HOUSING WAS OPENED REVEALING DEBRIS AND DISCOLORATION (DARK BROWN) INSIDE THE GEAR HOUSING. THE RESULTS FOUND THE INNER DRIVE SHAFT MISSING AND DEBRIS WITHIN THE GEAR HOUSING. SUBSEQUENTLY, THIS DEVICE¿S COMPLAINT CONDITION IS FOUND TO BE DUE TO LACK OF PROPER ASSEMBLY AND MAINTENANCE. 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: SUBJECT DEVICE HAS BEEN RECEIVED AND IS CURRENTLY IN THE EVALUATION PROCESS. INVESTIGATION IS ONGOING; NO CONCLUSION COULD BE DRAWN. DEVICE HISTORY REVIEW (LOT 8101489): MANUFACTURING LOCATION: (B)(4) - SUPPLIER: (B)(4) PRECISION MACHINING - MANUFACTURING DATE: JULY 23, 2010. NO NON-CONFORMANCE REPORTS 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. 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.

    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 15 OF 15 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    49939 HANDLE FOR 90° SCREWDRIVER INSTR,SURGICAL,ORTHOPEDIC,AC- POWERED MOTOR/ACCESS & ATTACH HWE SYNTHES SELZACH 8101489

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR