BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    135 DEG DHS PLATE-STD BARREL 10 HOLES/174MM-STERILE

    MDR report key: 5419240 · Received February 9, 2016

    Report

    Report Number
    3003506883-2016-10026
    Event Type
    Malfunction
    Date Received
    February 9, 2016
    Date of Event
    December 15, 2015
    Report Date
    December 15, 2015
    Manufacturer
    SYNTHES SELZACH
    Product Code
    KTT
    PMA / PMN Number
    PK791619
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL NARRATIVE: PATIENT IDENTIFIER AND WEIGHT ARE UNKNOWN. ADDITIONAL PRODUCT CODES FOR THIS REPORT INCLUDE HRS. (B)(4). THE COMPLAINANT PART HAS NOT BEEN EXPLANTED AT THIS TIME. THE COMPLAINANT PART IS NOT EXPECTED TO BE RETURNED MANUFACTURER REVIEW/INVESTIGATION. (B)(6). THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN AS NO PRODUCT WAS RECEIVED. A REVIEW OF THE DEVICE HISTORY RECORDS HAS BEEN REQUESTED AND IS PENDING COMPLETION. 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

    DEVICE HISTORY RECORDS WAS CONDUCTED. THE REPORT INDICATES THAT THE: PRODUCT MANUFACTURE DATE: JANUARY 24, 2005, PART EXPIRY DATE: N/A ¿ NON-STERILE PART, THE (DHR) SHOWS THIS LOT OF DHS PLATES WAS PROCESSED THROUGH THE NORMAL MANUFACTURING AND INSPECTION OPERATIONS. PRODUCT MANUFACTURE DATE: JANUARY 24, 2005PART EXPIRY DATE: N/A ¿ NON-STERILE PART A REVIEW OF THE DEVICE HISTORY RECORD (DHR) REVEALED TWO MATERIAL REVIEW RECORDS (MRR) WERE WRITTEN ON THE LOT OF 135 DEG DHS PLATE-STANDARD BARREL 10 HOLES/174MM (LOT 4920005). BOTH MRRS WERE FOR THE SUPPLIER¿S BAGS NOT BEING SEALED AT THE PERFORATED END. THE DISPOSITION WAS TO REWORK TO SEAL THE PERFORATED END OF THE BAG PRIOR TO PACKAGING THE PART. THE (DHR) SHOWS THIS LOT OF DHS PLATES WAS PROCESSED THROUGH THE NORMAL MANUFACTURING AND INSPECTION OPERATIONS. THIS ORDER MET ALL DIMENSIONAL AND VISUAL CRITERIA AT THE TIME OF RELEASE WITH NO ISSUES DOCUMENTED DURING THE MANUFACTURE THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. A REVIEW OF THE RAW MATERIAL DEVICE HISTORY RECORD REVEALED ONE MRR WRITTEN FOR THIS LOT. THE MRR WAS WRITTEN BECAUSE THE SUPPLIER CERTIFICATE DID NOT LIST AN ACTUAL SURFACE ROUGHNESS VALUE. THIS LOT WAS DISPOSITIONED AS ¿USE AS IS¿ AFTER MEASURING THE SURFACE ROUGHNESS WITH A PROFILOMETER AND FINDING THE MEASUREMENT TO BE ACCEPTABLE. THIS ISSUE REVIEWED WOULD CONTRIBUTE TO THE COMPLAINT CONDITION. DEVICE HISTORY RECORDS WAS CONDUCTED FOR THE STERILE PART. THE REPORT INDICATES THAT THE: MANUFACTURING SITE: (B)(4), SUPPLIER: (B)(4), MANUFACTURING DATE: 16. MAR. 2005 EXPIRY DATE: 01. MAR. 2015 DEVICE WAS MANUFACTURED UNSTERILE IN ELMIRA AND AFTERWARDS STERILIZED AT THE (B)(4) VIA SYNTHES (B)(4). THIS REVIEW IS FOR THE PACKAGING AND LABEL OF THE FINISHED STERILE PART. NO NCRS WERE GENERATED DURING PRODUCTION. REVIEW OF THE DEVICE HISTORY RECORD SHOWED THAT THERE WERE NO ISSUES DURING THE PACKAGING OF THE PRODUCT THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. AS VISIBLE ON THE ATTACHED LABEL VERIFICATION OF THIS LOT WAS THE LABEL BACK THEN CORRECT, THE EXPIRY DATE WAS WRITTEN ON THE LABEL AND DISPLAYED IN THE BAR CODE. SYNTHES MANUFACTURING LOCATION WAS DISCOVERED. 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 A DYNAMIC HIP SCREW (DHS) WAS IMPLANTED AFTER THE EXPIRATION DATE OF THE DEVICE. THE PATIENT IS CURRENTLY NOTED TO BE ¿FINE.¿ NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME. THIS REPORT IS 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    82478 135 DEG DHS PLATE-STD BARREL 10 HOLES/174MM-STERILE APPLIANCE, FIXATION, NAIL KTT SYNTHES SELZACH 4920005

    Patients

    Seq Age Sex Outcome Treatment
    1 84 YR