BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 4113713 · Received September 24, 2014

    Report

    Report Number
    0008031020-2014-00438
    Event Type
    Malfunction
    Date Received
    September 24, 2014
    Date of Event
    August 29, 2014
    Report Date
    August 29, 2014
    Manufacturer
    STRYKER GMBH
    Product Code
    LXH
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INVESTIGATION 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, A DESIGN IMPROVEMENT HAS BEEN MADE ON THE TIP OF THE DRILL GUIDE TO INCREASE THE RESISTANCE OF THE SLEEVE AND TO AVOID SUCH BREAKAGES. SEE CAPA, PR# (B)(4). THIS DEVICE HAS BEEN MANUFACTURED ACCORDING TO THE PREVIOUS VERSION. BASED ON INVESTIGATION, THE ROOT CAUSE OF THE DETERMINED FAILURE 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 OR MANUFACTURING RELATED PROBLEMS WERE NOT DETERMINED IN THE INVESTIGATION. DEVICE WAS NOT RETURNED.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    DURING THE INSPECTION OF THE RETURNED LONER INSTRUMENTS FROM THE HOSPITAL, IT WAS FOUND THAT THE TIP OF DRILL GUIDE BROKE.

    Description of Event or Problem · 1

    DURING THE INSPECTION OF THE RETURNED LONER INSTRUMENTS FROM THE HOSPITAL, IT WAS FOUND THAT THE TIP OF DRILL GUIDE BROKE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    595427 DRILL GUIDE - OVERDRILL Ø2.7MM & Ø3.5MM FOR 2.7 & 3.5 SCREWS ORTHOPEDIC MANUAL SURGICAL INSTRUMENT LXH STRYKER GMBH 03069R

    Patients

    Seq Age Sex Outcome Treatment
    1 Other