BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PELVREDUCFORCEPS ANGL Ø6.5 L200

    MDR report key: 3070028 · Received April 22, 2013

    Report

    Report Number
    8030965-2013-01783
    Event Type
    Malfunction
    Date Received
    April 22, 2013
    Report Date
    March 25, 2013
    Manufacturer
    SYNTHES GMBH
    Product Code
    HTD
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS DEVICE USED FOR TREATMENT AND NOT DIAGNOSIS. NO IRREGULARITIES WERE FOUND DURING THE DEVICE HISTORY RECORD REVIEW. HARDNESS OF THE MATERIAL IS CONFORMING AT 48 HRC. THE PRESENT PELVIC REDUCTION FORCEPS WAS ANALYZED FOR CONFORMANCE TO PRINT SPECIFICATIONS AS WELL AS THE DEVICE HISTORY RECORD WAS RESEARCHED; NO ABNORMAL FINDINGS WERE IDENTIFIED. MANUFACTURING AND INSPECTION RECORDS INDICATED NO PROBLEMS WITH THE LOT IN QUESTION. BASED ON THESE FINDINGS WE CONCLUDE THAT THE CAUSE OF FAILURE IS NOT DUE TO ANY MANUFACTURING NON-CONFORMANCES. WE ARE NOT ABLE TO DETERMINE THE EXACT CAUSE OF THIS OCCURRENCE AND CAN ONLY ASSUME THAT A MECHANICAL OVERLOAD CAUSED THE BREAKAGE OF THIS DEVICE.

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. SUBJECT DEVICE HAS BEEN RECEIVED AND IS CURRENTLY IN THE EVALUATION PROCESS. INVESTIGATION IS ON GOING; NO CONCLUSION COULD BE DRAWN. A REVIEW OF THE DEVICE HISTORY RECORDS HAS BEEN REQUESTED. PLACEHOLDER.

    Description of Event or Problem · 1

    DEVICE REPORT FROM SYNTHES (B)(4) REPORTS AN EVENT IN (B)(6) AS FOLLOWS: DURING A SIMPLE REDUCTION IN A SURGERY ON AN UNSPECIFIED DATE, THE ANGLED REDUCTION FORCEPS BROKE. REPORTEDLY THE PATIENT WAS NOT AFFECTED BY THIS EVENT, THE DELAY OF SURGERY WAS LESS THAN 20% AND THE INCIDENT DID NOT REQUIRE FURTHER TREATMENT. THIS IS 1 OF 1 REPORT FOR COMPLAINT #(B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    173104 PELVREDUCFORCEPS ANGL Ø6.5 L200 HTD SYNTHES GMBH T956861

    Patients

    Seq Age Sex Outcome Treatment
    1