BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    12.0MM/8.0MM PROTECTION SLEEVE 188MM

    MDR report key: 6401615 · Received March 13, 2017

    Report

    Report Number
    3003875359-2017-10112
    Event Type
    Malfunction
    Date Received
    March 13, 2017
    Date of Event
    February 17, 2017
    Report Date
    February 17, 2017
    Manufacturer
    SYNTHES HAGENDORF
    Product Code
    LXH
    UDI-DI
    07611819760905
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    A PRODUCT DEVELOPMENT INVESTIGATION WAS PERFORMED FOR THE SUBJECT DEVICE (12.0MM/8.0MM PROTECTION SLEEVE 188MM, PART NUMBER 03.010.063, LOT NUMBER 8780671). THE SUBJECT DEVICE WAS RETURNED WITH THE COMPLAINT CONDITION STATING: WE HAVE RECEIVED THE FOLLOWING INSTRUMENTS FOR INVESTIGATION: QTY. 1 / PART 03.010.063 / #LOT 8326169 / PROTECTION SLEEVE 12.0/8.0, L 188MM, QTY. 1 / PART 03.010.063 / #LOT 8780671 / PROTECTION SLEEVE 12.0/8.0, L 188MM, QTY. 2 / PART 03.010.060 / #LOT 9798550 / DRILL BIT Ø 3.2MM, CALIBRATED, L 340MM, QTY. 1 / PART 03.019.006 / #LOT 8320039 / INSERTION HANDLE F/MULTILOC¿ HUM. NAILING SYSTEM , QTY. 1 / PART 03.019.007 / #LOT 8404292 / CONNECTING SCREW, CANNULATED, QTY. 1 / PART 03.019.008 / #LOT 8519199 / AIMING ARM, LATERAL, F/MULTILOC¿ PROX. HUMERAL NAIL, QTY. 1 / PART 03.010.064 / #LOT 1873308 / DRILL SLEEVE 8.0/3.2, F/NO. 03.010.063, QTY. 1 / PART 03.010.064 / #LOT 8811560 / DRILL SLEEVE 8.0/3.2, F/NO. 03.010.063. THE MULTILOC PROXIMAL HUMERAL NAIL Ø 8.0MM, RIGHT (PART 04.016.034S / LOT # UNKNOWN / QUANTITY 1) WAS NOT RETURNED. THE ARTICLES ARE IN A USED CONDITION WITH SLIGHT SCRATCHES ON THE SURFACES & GUIDING HOLES. THE REST OF THE INSTRUMENTS ARE IN GOOD CONDITION. INVESTIGATION: A FUNCTIONAL TEST TOGETHER WITH PRODUCT DEVELOPMENT (SUSTAINING ENGINEERING) WAS PERFORMED. ANOTHER NAIL WAS AVAILABLE (WITH THE SAME PART NUMBER) TO REPRODUCE THE COMPLAINED ISSUE. THE RETURNED INSTRUMENTS PASSED THE FUNCTIONAL TEST SUCCESSFULLY. THE DRILL SLEEVES AND AS WELL THE DRILL BITS MET THE NAIL HOLES AS INTENDED. NO INTERFERING COULD BE DETECTED. CONCLUSION: UNFORTUNATELY WE ARE NOT ABLE TO DETERMINE THE EXACT CAUSE OF THIS COMPLAINT. BASED ON OUR INVESTIGATIONS, WE ONLY CAN ASSUME THAT POSSIBLY AN INSUFFICIENT CONNECTION, OR NOT EXACTLY FOLLOWING THE SURGICAL TECHNIQUE, COULD HAVE CONTRIBUTED TO THE COMPLAINED ISSUE. SINCE THE REPORTED OCCURRENCE COULD NOT BE REPRODUCED, WE DETERMINE THIS COMPLAINT AS UNCONFIRMED. 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

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. ADDITIONAL NARRATIVE: PATIENT INFORMATION IS NOT AVAILABLE FOR REPORTING. DEVICE IS AN INSTRUMENT AND IS NOT IMPLANTED/EXPLANTED. (B)(6). THE SUBJECT DEVICE HAS BEEN RECEIVED AND IS CURRENTLY UNDERGOING INVESTIGATION. A DEVICE HISTORY RECORD REVIEW WAS PERFORMED FOR THE REPORTED SUBJECT DEVICE LOT. MANUFACTURING LOCATION: SYNTHES (B)(4). DATE OF MANUFACTURE: FEB 13, 2014. THE REVIEW SHOWED THAT THERE WERE NO ISSUES DURING THE MANUFACTURE OF THE PRODUCT LOT THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. NO NON-CONFORMANCES WERE GENERATED DURING THE PRODUCTION OF THE SUBJECT DEVICE. 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

    PREVIOUSLY REPORTED CONCOMITANT DEVICES ON MEDWATCH REPORT (B)(4) ARE NOW DETERMINED AS THE REPORTABLE COMPLAINED DEVICES. 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

    SYNTHES EUROPE REPORTED AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT DURING SURGERY TO TREAT PROXIMAL HUMERAL FRACTURE ON (B)(6) 2017, THE SURGEON ATTEMPTED TO DRILL THE DISTAL HOLE BUT THE NAIL INTERFERED WITH TWO (2) BITS AND THE TWO (3) ASSOCIATED PROTECTION SLEEVES WOULD NOT COME OFF AND COULD NOT BE HELD DOWN. THE SURGEON ATTEMPTED THE FOLLOWING TO COMPLETE THE PROCEDURAL STEP: DRILLING WITHOUT PUSHING SLEEVE OR DRILL; DRILLING BY PUSHING THE DRILL WHEN DRILL INTERFERED WITH NAIL; HAMMERED AS DRILL INTERFERED WITH NAIL; TOOK INNER CYLINDER OFF AS DRILL INTERFERED WITH NAIL; AND PRE-DRILLED USING K-WIRE2.5. ALL THE TECHNIQUE ATTEMPTS FAILED SO THE SURGEON GAVE UP INSERTING A SCREW IN THE DISTAL HOLE OF THE NAIL. THE SURGEON INSERTED SCREWS IN THE PROXIMAL HOLE AND ASCENDING SCREW HOLE AND COMPLETED THE PROCEDURE. THE SURGERY WAS DELAYED FOR 15 MINUTES DUE TO THE COMPLAINT EVENT. THE SURGEON WAS NOT CONSIDERED TO BE SUCCESSFULLY COMPLETED BECAUSE THE SURGEON COULD NOT IMPLANT A SCREW IN THE DISTAL NAIL HOLE. THE PATIENT¿S POSTOPERATIVE STATUS WAS REPORTEDLY GOOD. ADDITIONAL MEDICAL INTERVENTION WAS NOT REQUIRED. CONCOMITANT DEVICE: 1X 03.010.064 / LOT UNK (DRILLSL 8/3.2 F/03.010.063); 1X 03.019.008 / LOT 8519199 (AIM-ARM LAT F/MULTILOC PHN); 1X 03.019.007 / LOT 8404292 (CONNECSCR CANN F/MULTILOC HUM NAIL SYST); 1X 03.019.006 / LOT 8320039 (INSERT-HANDLE F/MULTILOC HUM NAIL SYST). THIS REPORT IS 4 OF 5 FOR (B)(4).

    Description of Event or Problem · 1

    THIS IS REPORT 4 OF 10 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    181953 12.0MM/8.0MM PROTECTION SLEEVE 188MM ORTHOPEDIC MANUAL SURGICAL INSTRUMENT LXH SYNTHES HAGENDORF 8780671 07611819760905

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR 03.010.064, 8.0MM/3.2MM DRILL SLEEVE 200MM, QTY 1| 03.019.006, INSERT HANDLE MULTILOC HUM NAIL, QTY 1| 03.019.007, CON SCREW/CAN MULTILOC HUM NAIL, QTY 1| 03.019.008, AIM ARM/LAT/MULTLOCPR HUM NAIL, QTY 1