BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ROD INTRODUCTION PLIERS FOR SIDE-OPENING IMPLANTS

    MDR report key: 3967003 · Received July 30, 2014

    Report

    Report Number
    9680938-2014-10045
    Event Type
    Malfunction
    Date Received
    July 30, 2014
    Date of Event
    June 27, 2014
    Report Date
    July 1, 2014
    Manufacturer
    SYNTHES TUTTLINGEN
    Product Code
    HTC
    PMA / PMN Number
    PEXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE IS AN INSTRUMENT AND IS NOT IMPLANTED/EXPLANTED. ADDITIONAL MANUFACTURE DATE: APRIL 26, 2013. REVIEW OF THE DEVICE HISTORY RECORD SHOWED THAT THERE WERE NO ISSUES DURING THE MANUFACTURE OF THE PRODUCT THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. THE RAW MATERIAL WHICH WAS DELIVERED AS LOT 221302 IS CORRESPONDING TO THE SPECIFICATIONS. THE HARDNESS WAS MEASURED AT THE TIME OF THE MANUFACTURING AND WAS FOUND TO BE GOOD. SERVICE HISTORY REVIEW: LOT #T952448 NO SERVICE HISTORY REVIEW CAN BE PERFORMED AS THIS IS A LOT CONTROLLED ITEM. 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

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. ADDITIONAL NARRATIVE: AN EVALUATION WAS PERFORMED ON THE RETURNED DEVICE. THE CUSTOMER REPORTED THE COLLAR HOLDING TIPS WAS BROKEN OFF. LOOSE COMPONENT IS THE REASON FOR REPAIR. THE CAUSE OF THE ISSUE IS UNKNOWN. THIS ITEM WAS REPAIRED, PASSED FINAL INSPECTION AND RETURNED TO THE CUSTOMER. 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 SEVERAL INSTRUMENTS MALFUNCTIONED DURING A T10-ILIUM POSTERIOR LUMBAR FUSION FOR LEG PAIN AND DEFORMITY CORRECTION. IT WAS REPORTED THAT, DURING SET UP OF THE CASE PRIOR TO INCISION, ONE OF THE COLLAR HOLDING TIPS WAS BROKEN OFF A UNIVERSAL SPINE SYSTEM PERSUADER. IT WAS REPORTED THAT THE TIP OF A COUNTER TORQUE BROKE OFF DURING FINAL TIGHTENING. NO HARM WAS DONE TO THE PATIENT OR IMPLANTS FROM THIS TORQUE. THE FRAGMENT WAS REMOVED AND THE TORQUE WRENCH WAS USED WITH ANOTHER INSTRUMENT TO FINISH THE CASE. IT WAS REPORTED THAT THE TIP OF THE HEXAGONAL SCREWDRIVER WAS BROKE OFF DURING SCREW ADJUSTMENT. THE FRAGMENT FROM THE BROKEN SCREWDRIVER WAS FOUND AND NO HARM WAS DONE TO THE PATIENT OR IMPLANT. ANOTHER SCREWDRIVER WAS USED TO ADJUST THE SCREWS. NO PATIENT HARM WAS REPORTED. NO TIME DELAY WAS REPORTED. THIS IS REPORT 1 OF 3 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    444223 ROD INTRODUCTION PLIERS FOR SIDE-OPENING IMPLANTS PLIERS, SURGICAL HTC SYNTHES TUTTLINGEN T952448

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR