BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MEDULLARY REAMER Ø9 L385

    MDR report key: 2992092 · Received March 7, 2013

    Report

    Report Number
    1719045-2013-00456
    Event Type
    Malfunction
    Date Received
    March 7, 2013
    Date of Event
    February 6, 2013
    Report Date
    February 8, 2013
    Manufacturer
    SYNTHES MONUMENT
    Product Code
    HTO
    PMA / PMN Number
    K971544
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. DEVICE IS AN INSTRUMENT AND IS NOT IMPLANTED/EXPLANTED. SUBJECT DEVICE HAS BEEN RECEIVED AND IS CURRENTLY IN THE EVALUATION PROCESS. INVESTIGATION IS ON GOING; NO CONCLUSION COULD BE DRAWN.

    Additional Manufacturer Narrative · 1

    DEVICE IS USED FOR TREATMENT, NOT DIAGNOSIS THE DEVICE WAS RECEIVED WITH THE REAMER BROKEN OFF THE FLEXIBLE SHAFT, PERMANENT BENDS IN THE FLEXIBLE SHAFT, AND SCRATCHES ALONG THE FLEXIBLE SHAFT AND COUPLING. THE REAMER TIP IS NOT PRESENT. PRECIMED MANUFACTURED THE FLEXIBLE CANNULATED REAMER, 385MM, P/N 359.112, LOT 4817738. DUE TO AN UNKNOWN CAUSE, THE CANNULATED REAMER TIP BROKE OFF OF THE PART. THE MATERIAL OF THE FLEXIBLE SHAFT WAS DETERMINED TO DIFFER FROM THE SUPPLIERS SPECIFICATIONS. MATERIAL HARDNESS VALUES COULD NOT BE DETERMINED DUE TO PART GEOMETRY. THE INSTRUMENT CONFORMED TO ALL DIMENSIONAL SPECIFICATIONS AT THE TIME OF MANUFACTURING. THE REAMER WITHSTOOD THE SPECIFIED AMOUNT OF TORSIONAL FORCE. A CAPA DETERMINATION HAS BEEN OPENED.

    Additional Manufacturer Narrative · 1

    THIS DEVICE USED FOR TREATMENT AND NOT DIAGNOSIS. OUR INVESTIGATION HAS SHOWN THAT THE WELD CONNECTION BETWEEN THE FLEXIBLE SHAFT AND THE REAMER HEAD HAS BROKEN OFF DURING REAMING. THERE ARE NO OTHER DAMAGES VISIBLE. UNFORTUNATELY NO FURTHER DETAILS HAVE BEEN PROVIDED IN ORDER TO DETERMINE THE EXACT CAUSE WHICH HAS LEAD TO THIS DAMAGE. WE CAN ONLY SUPPOSE THAT TO MUCH MECHANICAL FORCE MAY HAVE BEEN THE CAUSE OF THIS BREAKAGE. NEVERTHELESS AS WE DID HAVE SIMILAR COMPLAINTS WITH OTHER ARTICLES OF THE SAME NATURE, WE DECIDED TO RETURN THIS INSTRUMENT BACK TO THE MANUFACTURER FOR A CLOSER INVESTIGATION. THE INVESTIGATION IS ONGOING.

    Additional Manufacturer Narrative · 1

    DEVICE USED FOR TREATMENT AND NOT DIAGNOSIS. A REVIEW OF SYNTHES DEVICE HISTORY RECORDS REVEALED THE FLEXIBLE CANNULATED REAMER WAS MANUFACTURED BY GREATBATCH MEDICAL. REVIEW OF THE DEVICE HISTORY RECORDS SHOWED THAT THERE WERE NO ISSUES DURING THE MANUFACTURE OF THE PRODUCT THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION.

    Description of Event or Problem · 1

    DEVICE REPORT FROM SYNTHES (B)(4) REPORTS AN EVENT IN (B)(6) AS FOLLOWS: ON (B)(6) 2013 IT WAS REPORTED THAT THE REAMER HEAD WAS FALLING OFF THE REAMER. THIS HAS OCCURRED 5 TIMES WITH THE SAME DEVICE. THIS IS 1 OF 4 REPORTS FOR THIS EVENT.

    Description of Event or Problem · 1

    THIS IS 1 OF 4 REPORTS FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    97792 MEDULLARY REAMER Ø9 L385 HTO SYNTHES MONUMENT 2210830001

    Patients

    Seq Age Sex Outcome Treatment
    1