BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STARDRIVE SCREWDRIVER SHAFT T8 105MM

    MDR report key: 4821750 · Received June 5, 2015

    Report

    Report Number
    2520274-2015-14279
    Event Type
    Malfunction
    Date Received
    June 5, 2015
    Date of Event
    May 14, 2015
    Report Date
    May 14, 2015
    Manufacturer
    SYNTHES MONUMENT
    Product Code
    OVE
    PMA / PMN Number
    PK112459
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A PRODUCT INVESTIGATION WAS COMPLETED: THE COMPLAINT CONDITION IS CONFIRMED AS THE DISTAL TIP IS WORN. EXCESSIVE FORCE, NOT FULLY SEATING THE SCREWDRIVER TIP, AND NOT REMOVING ALL BONEY INGROWTH WHEN USED FOR REMOVAL PROCEDURES WOULD LIKELY CONTRIBUTE THIS PARTICULAR COMPLAINT CONDITION. HOWEVER, SINCE THE SPECIFIC CIRCUMSTANCES OVER THE TWO YEARS OF USE AND AT THE TIME OF THE DAMAGE ARE UNKNOWN, THE ROOT CAUSE CANNOT BE DEFINITIVELY DETERMINED. THE RETURNED PART WAS DETERMINED TO BE SUITABLE FOR THE INTENDED USE WHEN EMPLOYED AND MAINTAINED AS RECOMMENDED AND THE RISK ASSESSMENT WAS FOUND TO ADEQUATELY ADDRESS THE COMPLAINT CONDITION. A DEVICE HISTORY RECORD (DHR) REVIEW WAS PERFORMED FOR THE RETURNED SCREWDRIVER SHAFT. UNIVERSAL PUNCH MANUFACTURED THE STARDRIVE SCREWDRIVER SHAFT T8, 105MM, PART NUMBER 314.467, LOT NUMBER 7102546. THE LOT CONFORMED TO THE UNIVERSAL PUNCH CERTIFICATE OF COMPLIANCE. THE PARTS WERE INSPECTED AND CONFORMED TO THE SYNTHES INCOMING INSPECTION AND FINAL INSPECTION SHEET. THERE WERE NO MATERIAL REVIEW REPORTS, NON-CONFORMANCE REPORTS, OR COMPLAINT-RELATED ISSUES WITH THIS LOT. FURTHER EVALUATION AT THE COMPLIANT HANDLING UNIT (CHU) SHOWS THAT THIS DEVICE IS INTENDED FOR USE IN SCREW INSERTION ACROSS VARIOUS PLATING PROCEDURES. IN THIS CASE THE REPORTED PROCEDURE WAS AN ORIF ELBOW FIXATION SO THE APPROPRIATE TECHNIQUE GUIDE WAS REVIEWED. THE RETURNED SCREWDRIVER SHAFT WAS RECEIVED WITH THE DISTAL TIP STRIPPED AND WITH A DENT AROUND THE CIRCUMFERENCE APPROXIMATELY 2MM FROM THE DISTAL END. THE PROXIMAL CONNECTING POST SHOWS WORN EDGES AND THE BALANCE OF THE DEVICE IS IN GOOD CONDITIONS. THE ETCHINGS ARE LEGIBLE. THUS, THE COMPLAINT CONDITION IS CONFIRMED BUT CANNOT BE REPLICATED AS THE DEVICE IS ALREADY WORN. A REVIEW OF THE CURRENT DESIGN DRAWING/MANUFACTURED REVISION WAS PERFORMED. DURING THE INVESTIGATION NO PRODUCT DESIGN ISSUES OR DISCREPANCIES WERE OBSERVED THAT MAY HAVE CONTRIBUTED TO THE COMPLAINT CONDITION. THE SHAFT IS MADE FROM CUSTOM 465 STAINLESS STEEL, WHICH IS A STANDARD MATERIAL FOR SYNTHES SCREWDRIVER SHAFTS AND ADEQUATE FOR THIS APPLICATION. THE RETURNED PART WAS DETERMINED TO BE SUITABLE FOR THE INTENDED USE WHEN EMPLOYED AND MAINTAINED AS RECOMMENDED. THE DISTAL TIP OF THE SHAFT IS CONSISTENT WITH THE RESULT FROM EXTENSIVE USE AND EXCESSIVE FORCE. PER THE TECHNIQUE GUIDE, THE FINAL TIGHTENING MUST BE DONE MANUALLY USING THE 1.2NM TORQUE LIMITING ATTACHMENT FOR THE 2.7MM VARIABLE ANGLE SCREWS. EXCESSIVE FORCE, NOT FULLY SEATING THE SCREWDRIVER TIP, AND NOT REMOVING ALL BONEY INGROWTH WHEN USED FOR REMOVAL PROCEDURES WOULD LIKELY CONTRIBUTE THIS PARTICULAR COMPLAINT CONDITION. HOWEVER, SINCE THE SPECIFIC CIRCUMSTANCES OVER THE TWO YEARS OF USE AND AT THE TIME OF THE DAMAGE ARE UNKNOWN, THE ROOT CAUSE CANNOT BE DEFINITIVELY DETERMINED. DURING THE INVESTIGATION NO PRODUCT DESIGN ISSUES OR DISCREPANCIES WERE OBSERVED THAT MAY HAVE CONTRIBUTED TO THE COMPLAINT CONDITION. 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.

    Additional Manufacturer Narrative · 1

    DHR REVIEW ¿ UNIVERSAL PUNCH MANUFACTURED THE STARDRIVE SCREWDRIVER SHAFT T8, 105MM, P/N 314.467, LOT NUMBER 7102546, FOR (B)(4) PARTS. THE LOT CONFORMED TO THE UNIVERSAL PUNCH CERTIFICATE OF COMPLIANCE, DATED FEBRUARY 11, 2013. THE PARTS WERE INSPECTED AND CONFORMED TO THE SYNTHES INCOMING INSPECTION AND FINAL INSPECTION. THERE WERE NO MRRS, NCRS, OR COMPLAINT-RELATED ISSUES WITH THIS LOT. (B)(4) PARTS WERE RELEASED TO THE WAREHOUSE ON FEBRUARY 25, 2013. THE STARDRIVE SCREWDRIVER SHAFT, T8, 105MM WAS MADE TO THE SYNTHES DRAWING, RELEASED JANUARY 23, 2013. 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.

    Additional Manufacturer Narrative · 1

    ADDITIONAL NARRATIVE: DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. EVENT DATE: UNKNOWN. DEVICE IS AN INSTRUMENT AND IS NOT IMPLANTED/EXPLANTED. WITHOUT A LOT NUMBER THE DEVICE HISTORY RECORDS REVIEW COULD NOT BE COMPLETED. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. MFR DATE: UNKNOWN. 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

    ADDITIONAL INFORMATION WAS REPORTED: SURGERY TAKING PLACE WAS FOR OPEN REDUCTION INTERNAL FIXATION OF THE ELBOW.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A STARDRIVE SCREWDRIVER SHAFT STRIPPED DURING SURGERY. THERE WAS NO SURGICAL DELAY REPORTED. THIS IS REPORT 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    365905 STARDRIVE SCREWDRIVER SHAFT T8 105MM INTERVERTEBRAL FUSION DEVICE W/INTEGRATED FIXATION, CERVICAL OVE SYNTHES MONUMENT 7102546

    Patients

    Seq Age Sex Outcome Treatment
    1 86 YR