BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HANDLE FOR 90° SCREWDRIVER

    MDR report key: 4439604 · Received January 21, 2015

    Report

    Report Number
    3000270450-2015-10028
    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
    HEALTH PROFESSIONAL

    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 HISTORY REVIEW (LOT 8101489): MANUFACTURING LOCATION: (B)(4)- SUPPLIER: DIENER AG 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.

    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

    A PRODUCT DEVELOPMENT EVALUATION WAS COMPLETED: THE TURNING HANDLE (PART 03.505.005 LOT 8102831) CAN BE ROTATED; HOWEVER, IT WAS OBSERVED THAT THE DISTAL END (INNER GEAR) WAS ABLE TO ROTATE, AND THE HANDLE ROTATION REVEALED ABNORMAL FRICTION AS WELL AS METAL-TO-METAL ROLLING SOUNDS. IT WAS NOTED THAT THE SCREWDRIVER SHAFT (PART 03.505.003 LOT 8101262) WAS PROPERLY CONNECTED TO THE SCREWDRIVER HANDLE (PART 03.505.004 LOT 8101489); THE THREADED COUPLING BETWEEN THE HANDLE AND THE SHAFT WAS FOUND TO BE IN GOOD CONDITION. UPON SEPARATION OF THE SCREWDRIVER HANDLE FROM THE SHAFT, THE INNER DRIVER SHAFT OF THE HANDLE (03.505.004) WAS FOUND TO SQUEAK WHEN THE TURNING HANDLE WAS ROTATED. THE SCREWDRIVER HANDLE (PART 03.505.004 LOT 8101489) WAS DISASSEMBLED WITH A SPANNER TOOL (PART 357.31.003). THE INNER DRIVE SHAFT OF THE SCREWDRIVER HANDLE (03.505.004) SHOWED SIGNS OF CORROSION AND DISCOLORATION (RED AND WHITE), A LOOSE DISTAL BALL BEARING, SMALL NOISE WHILE ROLLING THE PROXIMAL BEARING, DISPLACED C-CLIP AT PROXIMAL BEARING LOCATION, AND DEBRIS. THIS IS INDICATIVE OF A LACK OF LUBRICATION (I.E. DISASSEMBLY/MAINTENANCE) AND POTENTIALLY RUNNING THE DEVICE AT HIGHER SPEEDS (I.E. ABOVE THE RECOMMENDED LIMIT). EXAMINATION OF THE INNER DRIVE SHAFT OF THE SCREWDRIVER HANDLE REVEALED A DISPLACED C-CLIP USED TO SECURE THE PROXIMAL BALL BEARING TO THE PROPER LOCATION ON THE SHAFT INSTEAD THE HANDLE. THIS C-CLIP WAS ABLE TO BE REPOSITIONED (I.E. SECURED IN THE GROOVE) AND RETAINED ITS POSITION THROUGHOUT THE REMAINING HANDLING DURING THE INVESTIGATION. UPON REASSEMBLY, THE FRICTION WAS REDUCED AND THE METALLIC SOUND REMOVED. THE EXTERIOR OF THE SCREWDRIVER SHAFT (PART 03.505.003 LOT 8101262) WAS IN FAIR CONDITION WITH THE EXCEPTION OF THE INNER GEAR HOUSING LID WHICH EXHIBITED A FADED LASER ETCH. UPON DISASSEMBLY, IT WAS REVEALED THAT THE INNER DRIVE SHAFT HAD A BROKEN DISTAL BALL BEARING (I.E. BALLS MISSING), RED DISCOLORATION, BLACK PITTING CORROSION AND DEBRIS. THE INNER GEAR SHOWED SIGNED OF MIDDLE WEAR, HOWEVER, IT WAS SPECKLED THROUGHOUT WITH SMALL METALLIC PARTICULATE, WHICH COATED THE GEAR AND WAS EMBEDDED IN THE PEEK BUSHING. THE RESULTS FOUND SIGNIFICANT DISCOLORATION (RED AND WHITE) AND EXTENSIVE CORROSION THROUGHOUT THE DEVICE. THE INNER DRIVE SHAFTS SHOWED LITTLE TO NO SIGNS OF MAINTENANCE AND SEVERAL INDICATION OF MISUSE (I.E. USE AT EXCESSIVE SPEEDS) OF THE DEVICE INCLUDING A BROKEN BALL BEARING, LOOSE BEARING, DISPLACED C-CLIP AND METALLIC PARTICULATES. SUBSEQUENTLY THIS DEVICE¿S COMPLAINT CONDITION IS FOUND TO BE DUE TO LACK OF PROPER ASSEMBLY AND MAINTENANCE AND MISUSE. 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 14 OF 15 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    49157 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