BEUDAMED
    FDA Adverse Event Injury Summary report: N

    2.7MM TI VA LCKNG SCR SLF-TPNG WITH T8 STARDRIVE RECESS 16MM

    MDR report key: 5110728 · Received September 29, 2015

    Report

    Report Number
    3000270450-2015-10191
    Event Type
    Injury
    Date Received
    September 29, 2015
    Date of Event
    September 17, 2015
    Report Date
    September 17, 2015
    Manufacturer
    SYNTHES SELZACH
    Product Code
    HRS
    PMA / PMN Number
    PK103243
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(6). PRODUCT INVESTIGATION SUMMARY: RECEIVED PARTS - 04.211.016S / 8893703 ¿ VARIABLE ANGLE - LOCKSCR 2.7 HEAD 2.4 SELF-TAP L16 TA; 04.117.103S / 9331888 ¿ VARIABLE ANGLE - LCP DHP 2.7/3.5 DORSO-LAT W/SUPP-LAT. AS RECEIVED CONDITION: THE SCREW IN QUESTION (04.211.016S) HAS HEAVY WEAR AND TEAR SIGNS ON THE OUTSIDE THREAD OF THE SCREW HEAD. THE PLATE (04.117.103S) WAS RECEIVED IN ONE PIECE. THERE ARE SCRATCHES AND NICKS VISIBLE ON THE SURFACE. SOME THREADED HOLES ARE DAMAGED. BASED ON THE PROVIDED CLINICAL INFORMATION, IT IS IMPOSSIBLE TO DETERMINE THE EXACT CAUSE OF THIS OCCURRENCE. THE MANUFACTURING REVIEW SHOWS THAT THE PRODUCTION PROCEDURE WAS ACCORDING TO THE SPECIFICATIONS AND THERE WERE NO ISSUES THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. IT IS LIKELY THAT THE SCREW HAD NOT BEEN POSITIONED APPROPRIATELY, SO THE THREAD AT THE SCREW HEAD BECAME DAMAGED DURING INSERTION. BECAUSE OF THE DAMAGE, THE COMPLAINT RELEVANT DIMENSIONS COULD NOT BE CHECKED FOR DIMENSIONAL ACCURACY. DUE TO THE WEAR AND TEAR SIGNS, THE CAUSE OF FAILURE IS NOT DUE TO ANY MANUFACTURING NON-CONFORMANCES. NO PRODUCT FAULT COULD BE DETECTED. DEVICE 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

    ADDITIONAL NARRATIVE: PATIENT INFORMATION IS UNKNOWN. ADDITIONAL PRODUCT CODE: HWC. DEVICE WAS NOT IMPLANTED/EXPLANTED. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. DHR REVIEW IS FOR STERILIZATION PROCEDURE: MANUFACTURING LOCATION: (B)(4). SUPPLIER: (B)(4). MANUFACTURING DATE: 20MARCH2014. EXPIRY DATE: 01MARCH2024. NON-STERILE PART: 04.211.016, LOT 7593940: MANUFACTURING LOCATION: (B)(4). MANUFACTURING DATE: 12FEBRUARY2014. NO NON-CONFORMANCE REPORTS WERE GENERATED DURING PRODUCTION. REVIEW OF THE DEVICE HISTORY RECORD(S) SHOWED THAT THERE WERE NO ISSUES DURING THE MANUFACTURE OF THE PRODUCT THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. 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

    ADDITIONAL NARRATIVE: THE DEVICE WAS RECEIVED, THE INVESTIGATION COULD NOT BE COMPLETED, AND NO CONCLUSION COULD BE DRAWN, AS PRODUCT IS ENTERING THE COMPLAINT SYSTEM. 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 (B)(4) REPORTS AN EVENT IN (B)(6) AS FOLLOWS: DURING A SURGERY, A SURGEON TRIED TO INSERT THE REPORTED VARIABLE ANGLE (VA) LOCKING SCREW INTO THE HOLE OF MOST DISTAL SIDE OF THE REPORTED VA-LCP DHP (VARIABLE ANGLE-LOCKING COMPRESSION PLATE DISTAL HUMERAL PLATE) TO LOCK. HOWEVER, THE SURGEON WAS UNABLE TO TIGHTEN THE SCREW AS IT KEPT IDLING. DESPITE THE FACT THAT THE SURGEON USED A VA DRILL SLEEVE 2.7 TO INSERT THE SCREWS IN VARIABLE ANGLE MODE FOLLOWING THE MANUAL, TWO VA LOCKING SCREWS IN THE DISTAL HOLES COULD NOT BE TIGHTENED. GRADUALLY, THE THREAD OF THE HOLES OF PLATE WERE SHAVED AND SOME METAL DEBRIS CAME OUT. THEREFORE, THE SURGEON REMOVED THE REPORTED PLATE AND REPLACED WITH A LONGER ONE (FOUR-HOLE PLATE). ALTHOUGH MOST VA LOCKING SCREWS WERE LOCKED THIS TIME, THE REPORTED VA LOCKING SCREW IN THE DISTAL HOLE OF THE LONGER PLATE KEPT IDLING AGAIN. THE SURGERY WAS EXTENDED FOR THIRTY (30) MINUTES. NO ADVERSE CONSEQUENCES WERE REPORTED. THE SAME THING HAPPENED WHEN THEY TRIED TO INSERT THE REPORTED VA SCREW TO THE REPORTED PLATE AFTER THE SURGERY; THE VA SCREW KEPT IDLING AGAIN. THIS IS REPORT 2 OF 2 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    641669 2.7MM TI VA LCKNG SCR SLF-TPNG WITH T8 STARDRIVE RECESS 16MM PLATE, FIXATION, BONE HRS SYNTHES SELZACH 8893703

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention