BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    6.0MM/10.0MM STEPPED DRILL BITCANNULATED/LARGE QC/435MM

    MDR report key: 2925552 · Received January 22, 2013

    Report

    Report Number
    1719045-2013-00173
    Event Type
    Malfunction
    Date Received
    January 22, 2013
    Date of Event
    December 31, 2012
    Report Date
    December 31, 2012
    Manufacturer
    SYNTHES MONUMENT
    Product Code
    HTO
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS DEVICE IS USED FOR TREATMENT, NOT DIAGNOSIS. DURING THIS EVALUATION, THE RETURNED DRILL STOP WAS MATED WITH THE RETURNED STEPPED DRILL BIT AND SLIPPING OCCURRED ONCE FORCE WAS APPLIED. HOWEVER, THE DRILL STOP ONLY SLIPPED IN ONE DIRECTION - TOWARDS THE PROXIMAL END - AND NOT TOWARDS THE DISTAL END. THE RETURNED STEPPED DRILL BIT WAS MANUFACTURED IN JUNE 2010, WHILE THE DRILL STOP WAS MANUFACTURED ON APRIL 28 2010. CHANGES WERE MADE TO THE DESIGN OF THE DRILL STOP, AS WELL AS THE STEPPED DRILL BIT. THE REVISED DESIGNS OF THE DEVICES HAVE BEEN EVALUATED AND ARE DEEMED TO MEET THEIR INTENDED USE. HOWEVER, BOTH OF THESE DEVICES WERE MADE PRIOR TO THE CHANGES. THE TFN RISK ANALYSIS ADEQUATELY ASSESSES THE RISK OF THIS COMPLAINT CONDITION AS LESS SEVERE WITH A MODERATE SEVERITY OF HARM 3 AND AN IMPROBABLE PROBABILITY OF OCCURRENCE 1.

    Additional Manufacturer Narrative · 1

    THIS DEVICE IS USED FOR TREATMENT, NOT DIAGNOSIS. SUBJECT DEVICE HAS BEEN RECEIVED AND IS CURRENTLY IN THE EVALUATION PROCESS. THE LOT CONFORMED TO THE MATERIAL, HARDNESS, AND SPECIFICATIONS. THE DRILL BIT CONFORMED TO THE SYNTHES INCOMING FINAL INSPECTION SHEET. THERE WERE NO COMPLAINT-RELATED ISSUES THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION.

    Description of Event or Problem · 1

    DURING SURGERY FOR A RIGHT INTERTROCHANTERIC HIP FRACTURE ON (B)(6) 2012, THE COLLET OF A STEP DRILL BIT, THAT SETS THE DEPTH OF THE DRILL, SLID 5MM FURTHER THAN THE SET DEPTH CAUSING THE SURGEON TO DRILL THAT MUCH FURTHER INTO THE PATIENT. AFTER THEY HEARD A CLICK, NOTICING THEY DRILLED FURTHER THAN THEIR DESIRED DEPTH, IT WAS CONFIRMED VIA FLUOROSCOPY THAT THE FEMORAL HEAD WAS NOT PENETRATED BY THE DRILL. THE SURGEON THEN PLACED THE HELICAL BLADE WITHOUT INCIDENT. THE ORIGINAL SETTING WAS THE DEPTH OF THE SCREW THEREFORE THEY WERE OK WITH THE ADDITIONAL DEPTH. NO ADVERSE EFFECT TO THE PATIENT WAS REPORTED. SURGERY WAS PROLONGED ABOUT 10 MINUTES. THIS IS # 1 OF 2 REPORTS SUBMITTED ON THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    29414 6.0MM/10.0MM STEPPED DRILL BITCANNULATED/LARGE QC/435MM 6.0MM/10.0MM STEPPED DRILL BIT CANNULATED HTO SYNTHES MONUMENT U120289

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR DRILL STOP