BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    REDUCTION FORCEPS W/SERRATED JAW-LARGE HANDLE-SOFT RATCHET

    MDR report key: 3802526 · Received May 9, 2014

    Report

    Report Number
    3009417901-2014-10015
    Event Type
    Malfunction
    Date Received
    May 9, 2014
    Report Date
    April 11, 2014
    Manufacturer
    SYNTHES SALZBURG
    Product Code
    HTD
    PMA / PMN Number
    PEXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. DEVICE IS AN INSTRUMENT AND IS NOT IMPLANTED/EXPLANTED. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. 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. 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: A MANUFACTURING INVESTIGATION WAS CONDUCTED. THE REPORT INDICATES THAT THE LOCKING TEETH OF THE SOFT LOCK SYSTEM ARE WORN OUT. 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. WE ARE NOT ABLE TO DETERMINE THE EXACT CAUSE OF THE REPORTED PROBLEM. 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 SUCH DAMAGES MIGHT HAVE BEEN CREATED DUE TO CONTINUOUS MECHANICAL LOADINGS ON WHICH THE LOADING CAP IS SUBJECTED TO. 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

    IT WAS REPORTED THAT A PAIR OF REDUCTION FORCEPS WILL NOT HOLD COMPRESSION. THE RATCHET PORTION OF THE DEVICE IS WORN OUT AND THE RATCHET IS NOT GRIPPING THE CLAMP. THIS EVENT IS NOT RELATED TO ANY SPECIFIC CASE OR PATIENT. THIS REPORT IS 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    281625 REDUCTION FORCEPS W/SERRATED JAW-LARGE HANDLE-SOFT RATCHET FORCEPS HTD SYNTHES SALZBURG 5901903

    Patients

    Seq Age Sex Outcome Treatment
    1