BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    REDUC-FORCEPS TOOTHED SOFTLO L250

    MDR report key: 3171640 · Received June 15, 2013

    Report

    Report Number
    8030965-2013-03402
    Event Type
    Malfunction
    Date Received
    June 15, 2013
    Report Date
    June 3, 2011
    Manufacturer
    SYNTHES GMBH
    Product Code
    HTD
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SYNTHES IS SUBMITTING THIS REPORT AS A RESULT OF REMEDIATION ACTIVITIES RELATED TO FDA WARNING LETTER DATED FEBRUARY 2012. THE DEVICE LISTED IN THIS REPORT IS USED FOR TREATMENT, NOT DIAGNOSIS. ANY ADDITIONAL INFORMATION RECEIVED REGARDING THIS EVENT AFTER FILING THIS REPORT SHALL BE FILED ON A SUPPLEMENTAL MDR. ACTUAL EVENT DATE NOT KNOWN. THE DEVICE WAS RETURNED FOR INSPECTION AND THE EVENT WAS CONFIRMED. THE EVALUATION OF THE RETURNED DEVICE REVEALED THAT THE LOCKING TEETH OF THE SOFT LOCK SYSTEM ARE INDEED COMPLETELY WORN OUT. THE TEETH ARE BROKEN OFF DUE TO A HIGH MECHANICAL LOADING WHILE IN USE. WE ARE NOT ABLE TO DETERMINE THE EXACT CAUSE OF THE REPORTED PROBLEM. CONCLUSION: WE KNOW THAT THIS LOCKING MECHANISM IS RATHER DELICATE; NEVERTHELESS WE DO SUPPOSE THAT THE LOCKING EDGES BROKE OFF DUE TO TOO HIGH MECHANICAL FORCES WHICH WERE APPLIED DURING PROCEDURES. PLEASE NOTE THAT WHILE SUCH DAMAGES MIGHT HAVE BEEN CREATED DUE TO CONTINUOUS MECHANICAL LOADINGS ON WHICH THE LOADING CAP IS SUBJECTED TO, WE ARE NOT ABLE TO DETERMINE THE EXACT CAUSE OF THIS OCCURRENCE AND THE COMPLAINT CONDITION REMAINS UNKNOWN. A REVIEW OF THE DEVICE HISTORY RECORDS HAS BEEN REQUESTED.

    Additional Manufacturer Narrative · 1

    SYNTHES IS SUBMITTING THIS REPORT AS A RESULT OF REMEDIATION ACTIVITIES RELATED TO FDA WARNING LETTER DATED FEBRUARY 2012. THE DEVICE LISTED IN THIS REPORT IS USED FOR TREATMENT, NOT DIAGNOSIS. ANY ADDITIONAL INFORMATION RECEIVED REGARDING THIS EVENT AFTER FILING THIS REPORT SHALL BE FILED ON A SUPPLEMENTAL MDR.

    Additional Manufacturer Narrative · 1

    SYNTHES IS SUBMITTING THIS REPORT AS A RESULT OF REMEDIATION ACTIVITIES RELATED TO FDA WARNING LETTER DATED FEBRUARY 2012. DEVICE(S) LISTED IN THIS REPORT IS (ARE) USED FOR TREATMENT, NOT DIAGNOSIS. ANY ADDITIONAL INFORMATION RECEIVED REGARDING THIS EVENT AFTER FILING THIS REPORT SHALL BE FILED ON A SUPPLEMENTAL MDR. A REVIEW OF DEVICE HISTORY RECORDS FOR MANUFACTURING REVEALED NO COMPLAINT RELATED ISSUES.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DEVICE IS NOT WORKING WELL AND IS INHIBITED. NO FURTHER INFORMATION WAS PROVIDED. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    272520 REDUC-FORCEPS TOOTHED SOFTLO L250 HTD SYNTHES GMBH 5801884

    Patients

    Seq Age Sex Outcome Treatment
    1