BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 3223268 · Received July 12, 2013

    Report

    Report Number
    0008031020-2013-00219
    Event Type
    Malfunction
    Date Received
    July 12, 2013
    Date of Event
    June 14, 2013
    Report Date
    June 17, 2013
    Manufacturer
    STRYKER OSTEOSYNTHESIS-SELZACH
    Product Code
    LXH
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    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. WITHIN THE REVIEW IT WAS VERIFIED THAT THE FAILURE MODE, OCCURRENCE, HAZARD AND OVERALL RISK CATEGORY IS ADDRESSED ADEQUATELY (HCP RECOGNIZES AND HAS TIME-CONSUMING TROUBLE BUT CAN FIX IT IN A LIMITED TIME FRAME.). 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] 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

    IT WAS REPORTED THAT A PIECE AT THE FRONT EDGE (CLICK MECHANISM) OF THE REPORTED DEVICE HAS BEEN BROKEN OFF.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PIECE AT THE FRONT EDGE (CLICK MECHANISM) OF THE REPORTED DEVICE HAS BEEN BROKEN OFF.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    323732 DRILL GUIDE - OVERDRILL Ø2.7MM & Ø3.5MM FOR 2.7 & 3.5 SCREWS INSTRUMENT LXH STRYKER OSTEOSYNTHESIS-SELZACH 01207Z

    Patients

    Seq Age Sex Outcome Treatment
    1 Other