BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DRILL GUIDE - OVERDRILL Ø2.7MM & Ø3.5MM FOR 2.7 & 3.5 SCREWS

    MDR report key: 4201984 · Received October 27, 2014

    Report

    Report Number
    0008031020-2014-00492
    Event Type
    Malfunction
    Date Received
    October 27, 2014
    Date of Event
    October 1, 2014
    Report Date
    October 1, 2014
    Manufacturer
    STRYKER TRAUMA SELZACH
    Product Code
    HRS
    PMA / PMN Number
    K130009
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ONCE THE INVESTIGATION HAS BEEN COMPLETED ANY ADDITIONAL INFORMATION WILL BE REPORTED IN A SUPPLEMENTAL REPORT.

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: THE REPORTED EVENT THAT THE SLEEVE BROKE COULD BE CONFIRMED. THE POTENTIAL FOR PERFORMANCE IMPROVEMENT WITH TECHNICAL MEASURES ARE LIMITED DUE TO THE DIMENSIONAL RESTRICTIONS. AN INCREASE OF THE WALL THICKNESS OF THE DRILL SLEEVE IS NOT POSSIBLE AS THE OTHER AND INNER DIAMETER ARE GIVEN BY THE PLATE HOLE DIMENSION (SCREW SIZE) AND THE DRILL DIAMETER CORRELATING WITH THE SCREW SIZE. MATERIAL OR SURFACE TREATMENT CHANGES ARE ALSO NOT REALISTIC AS THE MATERIAL AND HARDNESS CHOICE CONFORM WITH GOOD ENGINEERING PRACTICE. THE FUNCTIONALITY AND SAFETY OF THE DRILL SLEEVE WAS VALIDATED ACCORDING DESIGN CONTROL FOLLOWING THE CORRECT OPERATIVE TECHNIQUE. [ORIGINAL STATEMENT R&D] HOWEVER, AN IMPROVEMENT HAS BEEN MADE ON THE TIP OF THE DRILL GUIDE INCREASING THE RESISTANCE OF THE DEVICE AND AVOIDING SUCH BREAKAGES. SEE CAPA HISTORY. THIS DEVICE HAS BEEN MANUFACTURED ACCORDING TO THE PREVIOUS VERSION. BASED ON INVESTIGATION, THE ROOT CAUSE WAS ATTRIBUTED TO A USER RELATED ISSUE. THE BREAKAGE WAS CAUSED BY A WRONG ANGULATION OF THE DRILL GUIDE. A REVIEW OF THE DEVICE HISTORY FOR THE REPORTED LOT DID NOT INDICATE ANY ABNORMALITIES. NO CORRECTIVE ACTIONS ARE REQUIRED AT THIS TIME. INDICATIONS FOR ANY MATERIAL, MANUFACTURING OR DESIGN RELATED PROBLEMS WERE NOT DETERMINED IN THE INVESTIGATION.

    Description of Event or Problem · 1

    DURING INSPECTION OF THE RETURNED LONER INSTRUMENTS FROM THE HOSPITAL, IT WAS FOUND THAT THE TIP OF DRILL GUIDE BROKE. ACCORDING TO SALES REP, DRILL GUIDE WAS NOT USED FOR THE OPERATION.

    Description of Event or Problem · 1

    DURING INSPECTION OF THE RETURNED LONER INSTRUMENTS FROM THE HOSPITAL, IT WAS FOUND THAT THE TIP OF DRILL GUIDE BROKE. ACCORDING TO SALES REP, DRILL GUIDE WAS NOT USED FOR THE OPERATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    683282 DRILL GUIDE - OVERDRILL Ø2.7MM & Ø3.5MM FOR 2.7 & 3.5 SCREWS PLATE, FIXATION, BONE HRS STRYKER TRAUMA SELZACH 01355Z

    Patients

    Seq Age Sex Outcome Treatment
    1 Other