BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SCREW FIXATION BONE

    MDR report key: 6915419 · Received October 5, 2017

    Report

    Report Number
    2520274-2017-12400
    Event Type
    Malfunction
    Date Received
    October 5, 2017
    Date of Event
    September 18, 2017
    Report Date
    September 18, 2017
    Manufacturer
    SYNTHES USA
    Product Code
    HWC
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE USED FOR TREATMENT, NOT DIAGNOSIS. PATIENT AGE, DOB & WEIGHT NOT PROVIDED FOR REPORTING. OTHER UDI: UNKNOWN, LOT NUMBER UNKNOWN. UDI UNAVAILABLE. THIS REPORT IS FOR (3) UNKNOWN 2.7MM VA LOCKING SCREWS / UNKNOWN LOT NUMBER. PATIENT HAD ORIGINAL SURGERY SOMETIME IN 2012. THREE (3) BROKEN 2.7MM VA LOCKING SCREWS THAT BROKE DURING REMOVAL DEVICE IS NOT EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION. CONCOMITANT DEVICES: ANTERIOR MEDIAL (VA) VARIABLE ANGLE PLATE (ITEM NUMBER UNKNOWN, LOT NUMBER UNKNOWN, QUANTITY 1 EACH), 3.5MM CORTEX SCREWS (ITEM NUMBER UNKNOWN, LOT NUMBER UNKNOWN, QUANTITY 4 EACH), 2.7MM VA LOCKING SCREWS. (ITEM NUMBER UNKNOWN, LOT NUMBER UNKNOWN, QUANTITY 5 EACH). THERAPY DATES: (B)(6) 2012. 510K#: UNKNOWN. (B)(4). WITHOUT A LOT NUMBER, THE DEVICE HISTORY RECORD REVIEW AND THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS NOT RETURNED AND NO LOT NUMBER WAS PROVIDED. BASED ON THE INFORMATION AVAILABLE, THIS COMPLAINT WILL BE ACCOUNTED FOR AND MONITORED VIA POST MARKET SURVEILLANCE ACTIVITIES. IF ADDITIONAL INFORMATION IS MADE AVAILABLE, THE INVESTIGATION WILL BE UPDATED AS APPLICABLE. 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

    A PRODUCT INVESTIGATION WAS PERFORMED. THIS COMPLAINT IS CONFIRMED AS THE SHAFTS OF THE THREE SCREWS CAN BE OBSERVED STUCK INTO THE THREE RETURNED EXTRACTION BOLTS (P/N 309.290). WHETHER THIS COMPLAINT CAN BE REPLICATED AT CUSTOMER QUALITY (CQ) IS NOT APPLICABLE FOR THIS COMPLAINT CONDITION AS THE BROKEN SCREW STEMS ARE STUCK INSIDE THE EXTRACTION BOLTS AND COULD NOT BE REMOVED AT THE CQ LOCATION. HENCE NO FURTHER INVESTIGATION INCLUDING THE MATERIAL CHECK COULD BE PERFORMED FOR THE UNKNOWN BROKEN SCREWS IN THE ABSENCE OF ANY OTHER IDENTIFICATION DETAILS. VISUAL INSPECTION UNDER 5X MAGNIFICATION, DEVICE HISTORY RECORD (DHR) REVIEW AND DRAWING REVIEW WERE PERFORMED AS PART OF THIS INVESTIGATION. NO PRODUCT DESIGN ISSUES OR DISCREPANCIES WERE OBSERVED. SCREW REMOVAL TECHNIQUE GUIDE WAS REFERRED DURING THIS INVESTIGATION. IT WAS VERIFIED THAT THE RECOMMENDED EXTRACTION BOLT (PER THE TECHNIQUE GUIDE) WAS USED FOR THE 2.7 MM SCREWS. THREE EXTRACTION BOLTS (P/N 309.290, LOT # 9671863, 9887660, L312720) WERE RECEIVED WITH BROKEN SCREW STEMS STUCK INSIDE THEM. THE OVERALL BALANCE OF THE THREE EXTRACTION BOLTS LOOKS IN A GOOD CONDITION WITH NO WEAR OR DAMAGE THAT WOULD AFFECT THE FUNCTIONALITY OF THE DEVICE. THE INTERNAL THREADING OF THE COUPLING END OF THE BOLTS COULD NOT BE INSPECTED DUE TO SCREW STEMS BEING STUCK INTO THEM. NO BROKEN OR MISSING FRAGMENTS FROM THE BOLTS. NO NEW MALFUNCTIONS WERE IDENTIFIED AS A RESULT OF THE INVESTIGATION. RELEVANT EXTRACTION BOLT FOR 2.7 MM DIAMETER SCREWS DRAWING WAS REVIEWED. THE DESIGN IS ADEQUATE FOR ITS INTENDED USE AND DID NOT CONTRIBUTE TO THIS COMPLAINT CONDITION. IT WAS VERIFIED THAT THE RECOMMENDED EXTRACTION BOLT (PER THE TECHNIQUE GUIDE) WAS USED FOR THE 2.7 MM SCREWS. AS PER THE COMPLAINT DESCRIPTION, THE BONE WAS HEALED DURING THE EXTRACTION OF THE BROKEN SCREWS. THIS CONDITION WOULD TEND TO INTRODUCE ADDITIONAL RESISTANCE DURING SCREW STEM EXTRACTION DUE TO BONY GROWTH AROUND THE STEM. TECHNIQUE GUIDE ALSO RECOMMENDS TO HOLD THE EXTRACTION BOLT AS VERTICAL AS POSSIBLE DURING THE ENTIRE EXTRACTION PROCESS. FAILURE TO DO SO, MAY END UP IN THE OBSERVED COMPLAINT CONDITION. THE EXACT ROOT CAUSE COULD NOT BE DETERMINED. NO NEW, UNIQUE OR DIFFERENT PATIENT HARMS WERE IDENTIFIED AS A RESULT OF THIS EVALUATION. THE RETURNED PART WAS DETERMINED TO BE SUITABLE FOR THE INTENDED USE WHEN EMPLOYED AND MAINTAINED AS RECOMMENDED. QUANTITY OF CONCOMITANT DEVICE 2.7MM VA LOCKING SCREWS CORRECTED FROM 5 TO 2. 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

    IT WAS REPORTED THAT THE PATIENT HAD ORIGINAL SURGERY SOMETIME IN 2012 FOR TREATMENT OF A DISTAL TIBIA FRACTURE. PATIENT WAS IMPLANTED WITH ONE (1) ANTERIOR MEDIAL (VA) VARIABLE ANGLE PLATE AND, NINE (9) SCREWS. FOUR (4) 3.5MM CORTEX SCREWS AND FIVE (5) 2.7MM VA LOCKING SCREWS. ON AN UNKNOWN DATE, POST-OPERATIVELY, PATIENT PRESENTED WITH INFECTION. ALSO, FOUR (4) 2.7MM VA LOCKING SCREWS WERE BROKEN. (B)(4). ON (B)(6) 2017 SURGEON REMOVED ONE (1) BROKEN VA LOCKING SCREW WITH NO ISSUES. THE END PORTION OF THREE (3) BROKEN VA LOCKING SCREWS WERE LEFT IN PATIENTS SHAFT TIBIA BONE. DURING THE REMOVAL OF ONE OF THE BROKEN SCREWS, AS THE SURGEON WAS USING THE EXTRACTION BOLT INSTRUMENT, THE SCREW SHAFT BROKE OFF INSIDE THE BOLT INSTRUMENT. SURGEON CHOOSE ANOTHER EXTRACTION BOLT INSTRUMENT THAT WAS AVAILABLE IN THE OPERATING ROOM TO REMOVE ANOTHER BROKEN SCREW AND THIS SCREW ALSO BROKE OFF INSIDE THE INSTRUMENT. SURGEON CHOOSE ANOTHER EXTRACTION BOLT INSTRUMENT TO REMOVE A THIRD SCREW AND THIS SCREW AGAIN BROKE OFF INSIDE THE INSTRUMENT. SURGEON WAS ONLY ABLE TO REMOVED ONE OF THE BROKEN SCREWS COMPLETELY FROM THE PATIENT¿S DISTAL TIBIA, BUT THREE (3) DISTAL BROKEN SCREW END PORTIONS WERE LEFT INSIDE THE BONE. SINCE THE TIBIA FRACTURE HAD ALREADY BEEN HEALED NO FURTHER BONE FIXATION WAS USED. PATIENT WAS REVISED TO ANTIBIOTIC CEMENT BEADS TO TREAT THE INFECTION. ALL IMPLANTS HAVE BEEN RETAINED BY THE HOSPITAL. REVISION SURGERY WAS COMPLETED SUCCESSFULLY WITH A 15-20 MINUTE TIME DELAY. PATIENT IS REPORTED IN STABLE CONDITION. SALES CONSULTANT HAS NO MORE INFORMATION TO REPORT ON THIS EVENT. THIS REPORT IS FOR THREE (3) DEVICES CONCOMITANT DEVICES: ANTERIOR MEDIAL (VA) VARIABLE ANGLE PLATE (ITEM NUMBER UNKNOWN, LOT NUMBER UNKNOWN, QUANTITY 1 EACH), 3.5MM CORTEX SCREWS (ITEM NUMBER UNKNOWN, LOT NUMBER UNKNOWN, QUANTITY 4 EACH), 2.7MM VA LOCKING SCREWS (ITEM NUMBER UNKNOWN, LOT NUMBER UNKNOWN, QUANTITY 5 EACH). (B)(4).

    Description of Event or Problem · 1

    THIS REPORT IS FOR THE THREE (3) UNKNOWN BROKEN 2.7MM VA LOCKING SCREWS THAT BROKE DURING REMOVAL. CONCOMITANT DEVICE REPORTED: 2.7MM VA LOCKING SCREWS. (PART # UNKNOWN, LOT # UNKNOWN, QUANTITY 2).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    698662 SCREW FIXATION BONE HWC SYNTHES USA

    Patients

    Seq Age Sex Outcome Treatment
    1