BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPIRAL BLADE INSERTER FOR TI HUMERAL NAILS

    MDR report key: 5107527 · Received September 28, 2015

    Report

    Report Number
    2530088-2015-10602
    Event Type
    Malfunction
    Date Received
    September 28, 2015
    Report Date
    September 16, 2015
    Manufacturer
    SYNTHES BRANDYWINE
    Product Code
    LXH
    PMA / PMN Number
    PEXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE IS AN INSTRUMENT AND IS NOT IMPLANTED/EXPLANTED. COMPLAINANT PART IS EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION, BUT HAS YET TO BE RECEIVED. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. DHR REVIEW ¿ DHR REVIEW FOR PART#358.696 LOT#4963299. RELEASE TO WAREHOUSE DATE: (B)(6) 2005. MANUFACTURED AT SYNTHES (B)(4) FACILITY. NO NCRS WERE GENERATED DURING PRODUCTION. REVIEW OF THE DEVICE HISTORY RECORD(S) SHOWED THAT THERE WERE NO ISSUES DURING THE MANUFACTURE OF THIS PRODUCT THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. 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

    PRODUCT INVESTIGATION SUMMARY: THE COMPLAINT CONDITION FOR THE SPIRAL BLADE INSERTER (PART 358.696 / LOT 4963299) WAS LIKELY CAUSED BY OVER TEN YEARS OF USE AND POSSIBLE ROUGH HANDLING DURING SURGERY OR STERILE PROCESSING; HOWEVER, THIS COMPLAINT IS NOT LIKELY A RESULT OF ANY DESIGN RELATED DEFICIENCY. THE SPIRAL BLADE INSERTER IS AN INSTRUMENT ROUTINELY USED IN THE TITANIUM CANNULATED HUMERAL NAIL SYSTEM PER THE TECHNIQUE GUIDE. THE DEVICE WAS RETURNED AND REPORTED THAT ONE OF THE TWO DISTAL PRONGS HAD BROKEN AND WAS MISSING. THIS CONDITION IS CONFIRMED - ONE OF THE TWO DISTAL PRONGS IS SHEARED OFF AND APPEARS TO HAVE BEEN POLISHED DOWN TO A SMOOTHENED HOMOGENOUS SURFACE. IT IS LIKELY THAT OVER TEN YEARS OF USE AND POSSIBLE ROUGH HANDLING DURING SURGERY OR STERILE PROCESSING HAS LED TO THIS COMPLAINT CONDITION. THE DEVICE WAS MANUFACTURED IN MARCH, 2005 AND IS OVER TEN YEARS OLD. THE BALANCE OF THE RETURNED DEVICE IS IN FAIRLY WORN CONDITION WITH SOME MARKINGS ALONG ITS LENGTH. THE ASSOCIATED DRAWING WAS REVIEWED AND DETERMINED TO BE SUITABLE FOR THE INTENDED DESIGN, APPLICATION, AND DIMENSIONAL CONFORMITY WHEN USED AS RECOMMENDED. DEVICE 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

    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 UPON INSPECTION OF THE FIELD EQUIPMENT SET, IT WAS NOTED THAT ONE OF THE TWO FINS WERE BROKEN FROM THE TIP OF THE BLADE INSERTER FOR EX HUMERAL NAIL. NO PATIENT INVOLVEMENT. THIS IS REPORT 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    639732 SPIRAL BLADE INSERTER FOR TI HUMERAL NAILS MISC ORTHO SURGICAL INSTR LXH SYNTHES BRANDYWINE 4963299

    Patients

    Seq Age Sex Outcome Treatment
    1