BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    IVORY CLAMP

    MDR report key: 2837127 · Received October 11, 2012

    Report

    Report Number
    1925223-2012-00190
    Event Type
    Malfunction
    Date Received
    October 11, 2012
    Report Date
    September 14, 2012
    Manufacturer
    HERAEUS KULZER LLC
    Product Code
    EEF
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    PULLING THE RUBBER DAM OVER THE CLAMP PLACES EXCESSIVE STRESS ON THE RUBBER DAM CLAMP BOX THAT COULD CAUSE THE CLAMP BOW TO FRACTURE. CONCLUSION: DEVICE WAS SUBJECTED TO EXTREME OVEREXTENSION BY THE USER. THE ASSISTANT HAS STATED THAT NO ONE WAS INJURED DURING THE INCIDENCE. ANALYSIS OF RETURNED BROKEN CLAMP. EVAL DATE: 10/10/2012. DOCUMENT NO: (B)(4). ITEM EVALUATED: CLAMP STYLE 13A. LOT NO: Y1. MFR DATE: 06/2011. RECEIPT DATE: 10/08/2012. COMPLAINT: BRAND NEW CLAMP BROKE IN PT'S MOUTH. EVAL SUMMARY: THE CLAMP IS DISTORTED FROM ITS ORIGINAL SHAPE. WHEN REASSEMBLED IT WAS OBVIOUSLY PERMANENTLY DEFORMED, VASTLY UNABLE TO RETURN TO ITS ORIGINAL FORMED SHAPE AND JAW PROXIMITY. A PURPLE BAND HAS APPARENTLY BEEN HEAT SHRANK OR COOKED AROUND THE BOW OF THE CLAMP BY THE END USER. EFFECT ON THE CLAMP BY THIS TAPE IS POTENTIALLY DAMAGING TO THE CLAMPS ORIGINAL HEAT TREATED AND TEMPERED (BCT) MARTENSITIC LATTICE STRUCTURE, AS WELL AS CONCENTRATING OF TENSION IN THE AREA OF THE TAPE. THERE IS ALSO A COATING OF A WHITISH CHEMICAL ON THIS CLAMP THAT WOULD NEED MORE EXTENSIVE ANALYSIS TO DETERMINE IF THIS COATING HAS ADDED CORROSION OR PITTING TO THE CLAMPS SURFACE. CAUSE OF BREAKAGE: MISUSE. CONCLUSION: OVEREXTENSION AND FOREIGN MATERIAL ATTACHED TO THE CLAMP CAUSED PERMANENT DEFORMATION TO THE CLAMP AND SUBSEQUENTLY BREAKAGE OF THE CLAMP. DUE TO THE AFOREMENTIONED FACT THAT THIS WAS CUSTOMER MISUSE, NO FURTHER ACTION IS DEEMED NECESSARY AT THIS TIME. THE INVESTIGATION IS CLOSED. CAPA MEASURES ARE NOT PROPOSED OR INITIATED.

    Description of Event or Problem · 1

    DEALER RETURNED CLAMP FOR CREDIT. CONTACTED THE DENTAL OFFICE. SPOKE TO AN ASSISTANT. SHE SAID THAT THEY PLACE THE LIGATED CLAMP ON TO EITHER A LOWER LEFT OR UPPER RIGHT MOLAR. THE DENTIST PULLS THE RUBBER DAM OVER THE CLAMP. SHE SAID THAT IS WHEN THE CLAMP BROKE IN HALF. SHE SAID THAT IS WHEN THE UNLIGATED SIDE SHOT OUT FROM UNDER THE DAM AND ONTO THE FLOOR. SHE SAID THAT THE LIGATED SIDE WAS IN THE PT'S MOUTH. SHE SAID THAT PIECE WAS SPLIT OUT BY THE PT. SHE SAID IT WAS WEIRD BECAUSE IT WAS A BRAND NEW CLAMP. SHE SAID THAT NO INJURIES OCCURRED DUE TO THE BREAKAGE AND EVERYONE WAS FINE. SHE DID NOT PROVIDE PT INFO OR INCIDENT DATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 IVORY CLAMP EEF CLAMP, RUBBER DAM EEF HERAEUS KULZER LLC SS 13A REG MOLAR Y1

    Patients

    Seq Age Sex Outcome Treatment
    1