BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FPS H-PLATE AND FPS 2.7MM STANDARD SCREW

    MDR report key: 3776103 · Received March 19, 2014

    Report

    Report Number
    2027754-2014-00005
    Event Type
    Malfunction
    Date Received
    March 19, 2014
    Date of Event
    January 29, 2014
    Report Date
    March 19, 2014
    Manufacturer
    OSTEOMED
    Product Code
    HRS
    PMA / PMN Number
    K091614
    Report Source
    Manufacturer report
    Reporter Location
    CO
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    RESULTS AND CONCLUSIONS CODES ARE NOT FINALIZED. OSTEOMED WILL REPORT CODES UPON CONCLUSION OF EVALUATION AND INVESTIGATION.

    Additional Manufacturer Narrative · 1

    THE EXACT ROOT CAUSE COULD NOT BE DETERMINED. AN EXAMINATION OF THE RETURNED DEVICES DID NOT IDENTIFY ANY ANOMALIES. THE LOT NUMBERS WERE NOT PROVIDED. THEREFORE, THE DEVICE HISTORY RECORD COULD NOT BE REVIEWED. REVIEW OF THIS CASE AGAINST OSTEOMED LABELING SHOWS THAT THE DOCTOR SELECTED A DRILL THAT IS SMALLER THAN THE REQUIRED SIZE DRILL FOR USE WITH THE 2.7MM SCREW. A 1.6MM DRILL WAS SELECTED VERSUS A 2.0MM DRILL. THEREFORE, THE HOLE PRE-DRILLED WAS SMALLER THAN REQUIRED. THIS COULD POTENTIALLY WEAKEN (OR BREAK) THE SCREWS DURING INSERTION. PER THE FOOT PLATING SYSTEM FMEA, THE OVERALL RISK SCORE FOR THIS FAILURE MODE IS LOW. THIS ISSUE WILL BE MONITORED THROUGH ROUTINE TRENDING. QA NOTE: DURING AN AUDIT OF MDR SUBMISSIONS, WE IDENTIFIED THAT THE FOLLOW UP FOR THIS REPORT WAS INADVERTENTLY NOT SUBMITTED.

    Description of Event or Problem · 1

    ON (B)(6) 2013, THE FOLLOWING PLATES AND SCREWS WERE IMPLANTED INTO (B)(6) YEAR OLD PATIENT: DEVICE NAME: FPS 2.7MM LAPIDUS PLATE RIGHT, PART NO.: 324-1290, LOT#: 193-6649; DEVICE NAME: FPS 2.7MM X 14MM STANDARD SCREW, PART NO.: 321-2714, LOT#: 1058850; DEVICE NAME: FPS 2.7MM X 16MM STANDARD SCREW, PART NO.: 321-2716, LOT #: 1057316; DEVICE NAME: FPS 2.7MM X 20MM STANDARD SCREW, PART NO.: 321-2720, LOT #: 1052981; FPS 2.7MM X 28MM STANDARD SCREW, PART NO.: 321-2728, LOT#: 1046974. SIX WEEKS AFTER SURGERY, THE PATIENT WAS AUTHORIZED TO STEP HER FOOT ON THE FLOOR. TWO MONTHS AFTER SURGERY, AN X-RAY SHOWED THAT THERE WAS ONE SCREW BROKEN. THREE MONTHS AFTER SURGERY ANOTHER E-RAY SHOWED THAT THERE WAS ANOTHER SCREW BROKEN; HOWEVER, THERE WAS GOOD BONE CONSOLIDATION. ALMOST 6 MONTHS AFTER SURGERY, THE PATIENT STARTED TO FEEL THAT SOMETHING WAS BOTHERING THE INSIDE OF HER FOOT. THE SURGEON DECIDED TO EXTRACT THE IMPLANTS (1 LAPIDUS PLATE + 2 BROKEN SCREWS + 2 SCREWS IN GOOD CONDITION). EXPLANT WAS PERFORMED ON (B)(6) 2014.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    164918 FPS H-PLATE AND FPS 2.7MM STANDARD SCREW PS LAPIDUS PLATE AND FPS SCREWS HRS OSTEOMED VARIOUS

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR