BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HANDLE FOR 90° SCREWDRIVER

    MDR report key: 4439598 · Received January 21, 2015

    Report

    Report Number
    3000270450-2015-10026
    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: 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

    ADDITIONAL NARRATIVE: A PRODUCT DEVELOPMENT EVALUATION WAS COMPLETED: THE TURNING HANDLE (PART 03.505.005 LOT 8136178) CAN BE ROTATED; HOWEVER, IT WAS OBSERVED THAT THE DISTAL END (GEAR COUPLING) DID NOT ROTATE. IT WAS NOTED THAT THE SCREWDRIVER SHAFT (PART 03.505.003 LOT 8101262) WAS LOOSELY CONNECTED TO THE SCREWDRIVER HANDLE (PART 03.505.004 LOT 8134069); HOWEVER, THE THREADED COUPLING BETWEEN THE HANDLE AND SHAFT WAS FOUND TO BE IN GOOD CONDITION, WITH THE PRESENCE OF A CLEAR FLUID (POSSIBLY A LUBRICANT) AT THE COUPLING COLLAR. THE SCREWDRIVER HANDLE (PART 03.505.004 LOT 8134069) FUNCTIONED NORMALLY. THE SCREWDRIVER SHAFT (PART 03.505.003 LOT 8101262) EXTERIOR WAS FOUND TO BE IN GOOD CONDITION; HOWEVER, THE INNER DRIVE SHAFT WAS MISSING. THE DISTAL INNER GEAR SHOWED SIGNIFICANT SIGNS OF WEAR AND EXTENSIVE DISCOLORATION (RED) AS WELL AS THE PRESENCE OF DEBRIS. THE DISCOLORATION WAS ALSO NOTED TO BE INSIDE THE GEAR HOUSING AS WELL AS A DARK (NEAR BLACK) CRUST PRESENT AT THE GEAR HOUSING THREAD AND LID. THE DISCOLORATION, DEBRIS AND CRUST IS INDICATIVE OF A LACK OF DISASSEMBLY, CLEANING AND MAINTENANCE. THE INNER GEAR BUSHING REVEALED SIGNED OF AUGMENTATION AND SMEARING. FOR THIS TO OCCUR, THE PEEK BUSHING MUST UNDERGO LOCAL HEATING NEAR OR IN EXCESS OF THE GLASS TRANSITION TEMPERATURE. PEEK HAS A GLASS TRANSITION TEMPERATURE AT APPROXIMATELY 145 DEGREES CELSIUS. THIS AUGMENTATION IS INDICATIVE OF FRICTION INDUCED HEATING AS A RESULT OF HIGH-SPEED USE. THE RESULTS FOUND THE INNER DRIVE SHAFT MISSING, DEBRIS WITHIN THE GEAR HOUSING AND SUBSTANTIAL AUGMENTATION OF THE PEEK BUSHING. THE DEVICE¿S COMPLAINT CONDITION IS FOUND TO BE DUE TO THE LACK OF PROPER ASSEMBLY AND MAINTENANCE AS WELL AS MISUSE (I.E. EXCEEDING THE INDICATED SPEED). 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.

    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 12 OF 15 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    49155 HANDLE FOR 90° SCREWDRIVER INSTR,SURGICAL,ORTHOPEDIC,AC POWERED MOTOR/ACCESS & ATTACH HWE SYNTHES SELZACH 8134069

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR