BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROTECT SLEEVE 16/11 F/PFNA BLADE

    MDR report key: 4036565 · Received August 26, 2014

    Report

    Report Number
    9612488-2014-10349
    Event Type
    Malfunction
    Date Received
    August 26, 2014
    Report Date
    July 29, 2014
    Manufacturer
    SYNTHES BETTLACH
    Product Code
    HWE
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. DEVICE IS AN INSTRUMENT AND IS NOT IMPLANTED/EXPLANTED. (B)(6). THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS THE PRODUCT IS ENTERING THE COMPLAINT SYSTEM. A REVIEW OF THE DEVICE HISTORY RECORDS WAS PERFORMED AND NO COMPLAINT RELATED ISSUES WERE FOUND. 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

    A MANUFACTURING EVALUATION WAS COMPLETED: THE PRESENT PROTECTION SLEEVES WERE AS FAR AS POSSIBLE ANALYZED FOR CONFORMANCE TO PRINT SPECIFICATIONS AS WELL AS THE DEVICE HISTORY RECORDS WERE RESEARCHED; NO ABNORMAL FINDINGS WERE IDENTIFIED. MANUFACTURING AND INSPECTION RECORDS INDICATED NO PROBLEMS WITH THE LOTS IN QUESTION. THE LOT 2241751 WAS MANUFACTURED IN FEBRUARY 2007 WITH A LOT SIZE OF (B)(4) PIECES. BASED ON THESE FINDINGS WE CONCLUDE THAT THE CAUSE OF FAILURE IS NOT DUE TO ANY MANUFACTURING NON-CONFORMANCES. OUR INVESTIGATION HAS SHOWN THAT THE TIP FROM THE SLEEVE WITH LOT 2241751 IS DEFORMED AND THAT THERE NO MATERIAL IS MISSING. BASED ON THE APPEARANCE OF THE DAMAGE WE ASSUME THAT EITHER A HIT WITH ANOTHER INSTRUMENT OR A DROP TO THE GROUND CAUSED THIS DEFORMATION. FURTHERMORE WE MADE AN ANALYSIS OF THE ENCLOSED PARTICLES. THE VISUAL INSPECTION WITH 10X MAGNIFICATION HAS SHOWN THAT THERE COMPARATIVELY LARGE DRILLING CHIPS ARE EMBEDDED IN A WHITISH MASS. AN ENERGY DISPERSIVE X-RAY ANALYSIS OF THESE PARTICLES WAS. BASED ON THE DETECTED ELEMENTS IT IS LIKELY THAT THE RESIDUES ARE BONE MATERIAL IN COMBINATION WITH TAN ((B)(4)) DRILLING CHIPS. THUS IT CAN BE EXCLUDED THAT THESE CHIPS ARE FROM THE PROTECTION SLEEVES BECAUSE THEY ARE MADE OUT OF STAINLESS STEEL. IT IS LIKELY THAT THE CHIPS ARE FROM AN EXCESSIVE CONTACT DURING THE HOLE PREPARATION FOR THE BLADE BETWEEN THE REAMER AND THE NAIL, WHICH IS MADE OUT TAN. NO PRODUCT FAULT COULD BE DETECTED. THE METAL SHAVINGS ARE NOT FROM THE SLEEVE THEREFORE THIS COMPLAINT IS UNCONFIRMED. 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

    DEVICE REPORT FROM SYNTHES (B)(4) REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT METAL SHAVINGS FOUND ON KIT. AN INSPECTION SHOWED THAT A PIECE OR THE TIP WAS BROKEN OFF OF THE KIT. THIS REPORT IS 1 OF 1 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    516266 PROTECT SLEEVE 16/11 F/PFNA BLADE INSTR,SURGICAL,ORTHOPEDIC,AC-POWERED MOTOR/ACCESS & ATTACH HWE SYNTHES BETTLACH 2241751

    Patients

    Seq Age Sex Outcome Treatment
    1