BEUDAMED
    FDA Adverse Event Other Summary report: N

    INION OTPS 2.0 PIN KIT

    MDR report key: 1549540 · Received November 30, 2009

    Report

    Report Number
    9710629-2009-00003
    Event Type
    Other
    Date Received
    November 30, 2009
    Date of Event
    October 16, 2009
    Report Date
    November 27, 2009
    Manufacturer
    INION OY
    Product Code
    HTY
    PMA / PMN Number
    K031712
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ACCORDING TO THE RECEIVED INFORMATION, THREE DAYS AFTER IMPLANTING AN INION OTPS PIN, THE TOE WAS RED, SWOLLEN AND HOT. ANTIBIOTIC TREATMENT WAS GIVEN. TEST RESULTS GAVE NO INDICATION OF ALLERGIC REACTION OR ELEVATED WHITE BLOOD CELLS. THE SITE WAS OPENED ON THE 5TH DAY AND PIN REMOVED. THE BONE SURROUNDING THE PIN WAS BLACK. THE RETAIN SAMPLES WERE INSPECTED FOR STERILIZATION INDICATOR. ALL STERILIZATION INDICATORS SHOW THAT THE LOT IS PROVIDED STERILE. NO SIMILAR COMPLAINTS HAVE BEEN REPORTED TO INION. IT IS ESTIMATED THAT THE MOST LIKELY ROOT CAUSE FOR THIS INCIDENT IS THAT THE BONE HAS GONE TO THE THERMAL NECROSIS DURING THE DRILLING OF THE SCREW HOLE. IN GENERAL, PROBLEMS CAUSING OVERHEATING MAY BE RELATED TO INSUFFICIENT IRRIGATION OR A BLUNT DRILL BIT/ K-WIRE IN CASE OF REUSABLE INSTRUMENTS (IN THIS CASE, THE INSTRUMENTS WERE SINGLE USE). IT IS RECOMMENDED TO USE LOW SPEED DRILLING, TOGETHER WITH COOLING IRRIGATION. IN CASE OF REUSABLE INSTRUMENTS, A SHARP/NEW K-WIRE IS TO BE USED. THE INSTRUCTIONS FOR USE OF INION OTPS PIN STATE: IMPLANTATION OF THE PIN WITH DISPOSABLE SINGLE USE INSTRUMENTS: IRRIGATE THE DRILL HOLE. WARNINGS: INCORRECT SELECTION, PLACEMENT, POSITIONING AND FIXATION OF THE IMPLANT CAN CAUSE SUBSEQUENT UNDESIRABLE RESULTS. THE SURGEON SHOULD BE FAMILIAR WITH THE DEVICES, THE METHOD OF APPLICATION AND THE SURGICAL PROCEDURE PRIOR TO PERFORMING THE SURGERY.

    Description of Event or Problem · 1

    INION PIN WAS PLACED ON (B)(6) 2009. AS A SIDE NOTE, ON (B)(6) 2009, THE PATIENT FELL AND WAS TAKEN TO THE EMERGENCY ROOM. THERE WAS NO VISIBLE INJURY TO THE TOE OR THE SUTURE. THE PATIENT WAS GIVEN A BOOT TO WALK IN FOR SAFE MEASURE. ON MONDAY, THE PATIENT CAME IN FOR HIS CHECK-UP AND THE AREA SURROUNDING THE SURGERY (WHERE THE PIN WAS PLACED) WAS RED, SWOLLEN AND HOT. THE DOCTOR TOOK X-RAYS AND LAB TESTS AND PUT THE PATIENT ON AN ANTIBIOTIC. THE TESTS CAME BACK WITH NO INDICATION OF ALLERGIC REACTION OR ELEVATED WHITE BLOOD CELLS. ON WED, (B)(6), THE AREA WAS STILL HOT, SWOLLEN AND RED. SHE PUT THE PATIENT ON A MORE AGGRESSIVE ANTIBIOTIC AND TOOK MORE TESTS - ALL OF WHICH CAME BACK NEGATIVE TO HAVING ANY ALLERGIC REACTION. ON FRIDAY, (B)(6) THE PATIENT WAS TAKEN TO THE OPERATING ROOM AND THE DOC REMOVED THE PIN. WHEN SHE RE-OPENED THE INCISION, THE BONE SURROUNDING THE PIN WAS BLACK. SHE REMOVED A PORTION OF THE BLACK, NECROTIC BONE AS WELL AS THE PIN. THE PIN IS CURRENTLY IN PATHOLOGY AND RESULTS ARE UNKNOWN. ON MONDAY THE PATIENT WAS SEEN AGAIN IN THE CLINIC AND THERE WAS NO SIGN OF INFECTION (NOR WAS THE INCISION AREA RED, SWOLLEN AND HOT).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INION OTPS 2.0 PIN KIT BONE PIN HTY INION OY PCK-7002 0812021

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Required Intervention