BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BIT, DRILL

    MDR report key: 6980908 · Received October 26, 2017

    Report

    Report Number
    2520274-2017-12536
    Event Type
    Malfunction
    Date Received
    October 26, 2017
    Date of Event
    September 28, 2017
    Report Date
    September 28, 2017
    Manufacturer
    SYNTHES (USA)
    Product Code
    HTW
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PATIENT INFORMATION NOT AVAILABLE FOR REPORTING. THIS REPORT IS FOR AN UNKNOWN DRILL BIT. PART AND LOT NUMBERS ARE UNKNOWN; UDI NUMBER IS UNKNOWN. DEVICE IS AN INSTRUMENT AND IS NOT IMPLANTED/EXPLANTED. COMPLAINANT PART IS EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION, BUT HAS YET TO BE RECEIVED. HOSPITAL TELEPHONE NOT AVAILABLE FOR REPORTING. WITHOUT A LOT NUMBER THE DEVICE HISTORY RECORDS REVIEW COULD NOT BE COMPLETED. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Additional Manufacturer Narrative · 1

    THE COMPLAINED DEVICE WAS NOT RETURNED. HOWEVER, THREE (3) CONCOMITANT DEVICES WERE RETURNED. AN INVESTIGATION WAS CONDUCTED ON THESE DEVICES. WE HAVE RECEIVED THREE PARTS BACK. ALL OF THEM WERE RATED AS CONCOMITANT AS NO ALLEGATION WAS POINTED ON THEM: 1X INSERTION HANDLE (PART 03.010.405 LOT 3491506), 1X CONNECTING SCREW (PART 357.029 LOT 2075168), 1X AIMING ARM (PART 03.010.406 LOT 7841813). A FUNCTIONAL TEST TOGETHER WITH PD STAFF TOOK PLACE AND A VISUAL EXAMINATION: THE HAMMERING MARKS PRESENT ON THE INSERTION HANDLE (03.010.405) SHOWS THAT IT HAS BEEN HAMMERED WITHOUT THE 03.010.424 (CONNECTOR FOR INSERTION HANDLE FOR PFNA). THE HAMMERING MARKS PRESENT ON THE REVERSE SIDE OF THE INSERTION HANDLE (03.010.405) SHOWS THAT THE INSERTION HANDLE WAS USED TO EXTRACT THE NAIL INSTEAD. AFTER HAVING INSERTED THE NAIL, THE FIRST STEP IS TO MAKE SURE THE CONNECTING SCREW IS WELL TIGHTENED. SEE SURGICAL TECHNIQUE PAGE 22. THERE¿S A PRECAUTION IN THE DISTAL HOLE DRILLING SECTION (SEE PAGE 45) TO ENSURE PROPER CONNECTION BETWEEN NAIL & INSTRUMENTS. THERE¿S 2 DIFFERENT HOLES IN THE AIMING ARM 03.010.406 DEPENDING ON THE NAIL LENGTH (PFNA SHORT ARE AVAILABLE IN 170, 200 AND 240MM LENGTH). IF THE PROTECTION SLEEVE WAS INSERTED INTO THE INAPPROPRIATE HOLE, THE DRILL BIT WOULD HIT THE NAIL. THERE¿S NO DETAIL ON THE IMPLANTS USED IN THE COM DESCRIPTION. WE PICKED ONE OPTION (LOCKING BOLTS B 4.9 MM) AND A NAIL LENGTH 240MM FOR THE FUNCTIONAL TEST. ARTICLES USED TO SIMULATE THE DRILLING IN DISTAL HOLE. 473.802S CHARGE 2389234, 356.831 CHARGE 2471216, 356.828 CHARGE 2116033, 356.834 CHARGE 2101486. AS IT IS UNKNOWN WHICH IMPLANTS AND WHICH DRILL BITS WERE USED FOR THIS SURGERY AND THE COMPLAINED PARTS HAVE NOT BEEN RETURNED WE WERE LIMITED ON OUR INVESTIGATION. WE DO STRONG REFER ON TO THE SURGICAL GUIDE: PFNA-II. PROXIMAL FEMORAL NAIL ANTIROTATION. SURGICAL TECHNIQUE: FUNCTIONAL TEST DID NOT SHOW ANY DEVIATION. EXACT ROOT CAUSE WAS NOT DETERMINABLE. DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Description of Event or Problem · 1

    DEVICE REPORT FROM SYNTHES EUROPE REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED DURING A PROCEDURE FOR A FEMUR TROCHANTERIC FRACTURE ON (B)(6) 2017, AFTER INSERTING THE PROXIMAL FEMORAL NAIL ANTIROTATION (PFNA), SURGEON DRILLED INTO THE DISTAL LOCKING HOLE. THE DRILL BIT INTERFERED WITH THE LOCKING HOLE AND SURGEON COULD NOT INSERT THE LOCKING BOLT INTO THE HOLE. SURGERY WAS COMPLETED SUCCESSFULLY WITH NO DELAY AND NO ADVERSE CONSEQUENCE TO THE PATIENT. CONCOMITANT DEVICES REPORTED: RADIOLUCENT INSERTION HANDLE FOR TROCHANTERIC FIXATION NAILS (03.010.405, LOT 3491506, QUANTITY 1), CONNECTING SCREW (357.029, LOT 2075168, QUANTITY 1), AIMING ARM (03.010.406, LOT 7841813, QUANTITY 1), PFNA NAIL (QUANTITY 1), PROTECTION SLEEVE (QUANTITY 1), DRILL SLEEVE (QUANTITY 1), TROCAR (QUANTITY 1) THIS REPORT IS FOR ONE (1) UNKNOWN DRILL BIT. THIS IS REPORT 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    760998 BIT, DRILL HTW SYNTHES (USA)

    Patients

    Seq Age Sex Outcome Treatment
    1