BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STERNAL ZIPFIX WITH NEEDLE STERILE/ 5 PACK

    MDR report key: 4027602 · Received August 21, 2014

    Report

    Report Number
    9612488-2014-10338
    Event Type
    Malfunction
    Date Received
    August 21, 2014
    Date of Event
    July 23, 2014
    Report Date
    July 25, 2014
    Manufacturer
    SYNTHES BETTLACH
    Product Code
    JDQ
    PMA / PMN Number
    PK110789
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL NARRATIVE: A PD EVALUATION WAS CONDUCTED. THE REPORT INDICATES THAT DEVICES WERE RETURNED (NEEDLE SECTION) SHOW A CLEAN SNAP FRACTURE LINE BEHIND THE NEEDLE COMPONENT OF THE DEVICES. NO BENDING OR CUTTING TOOL SEAMED TO HAVE BEEN USED PRIOR TO WEAKEN THE DEVICE. SIMILAR SNAP FRACTURES HAVE BEEN DOCUMENTED IN PREVIOUS COMPLAINTS (3 IN TOTAL) HOWEVER THE FRACTURE LINES ON THOSE IMPLANTS WAS CLOSER TO THE STEEL NEEDLE ITSELF. THE SNAP FRACTURE AT THESE TWO IMPLANTS CAN NOT BE EXPLAINED BY PRODUCT DEVELOPMENT. THERE HAVE BEEN MORE THEN (B)(4) IMPLANTS SOLD VS. (B)(4) IMPLANTS RETURNED WITH SIMILAR FRACTURES. THE PRODUCT DEVELOPMENT INVESTIGATION IS CLOSED AS IN-CONCLUSIVE. 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: A MANUFACTURING INVESTIGATION WAS CONDUCTED. THE REPORT INDICATES THAT NO ISSUES OCCURRED DURING THE MANUFACTURING OF ARTICLE #(B)(4)/ LOT#8780284. THE COMPLAINT FROM THE CUSTOMER COULD NOT BE RECONSTRUCTED. THE MANUFACTURING DOCUMENTATION DID NOT SHOW ANY ABNORMALITIES/ DEVIATIONS. 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

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. THE DEVICE WAS RECEIVED, THE INVESTIGATION COULD NOT BE COMPLETED, AND NO CONCLUSION COULD BE DRAWN, AS PRODUCT IS ENTERING THE COMPLAINT SYSTEM. NO NCRS WERE GENERATED DURING PRODUCTION. REVIEW OF THE DEVICE HISTORY RECORD(S) 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.

    Description of Event or Problem · 1

    DEVICE REPORT FROM SYNTHES (B)(4) REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT TWO OF THE IMPLANTS/NEEDLES BROKE/SNAPPED OFF AS THE SURGEON WAS TRYING TO PULL THEM AROUND THE SECOND HALF (DIRECTLY AT THE JUNCTION BETWEEN THE NEEDLE AND THE IMPLANT) OF THE STERNUM. THE THIRD ONE HE DID NOT IMPLANT BUT JUST PLAYED WITH IN HIS HAND TWISTING THE JUNCTION AREA AND AFTER 3 LIGHT TURNS THIS THIRD DEVICE BROKE IN THE SAME LOCATION. THREE OUT OF A PACK OF FIVE BROKE . THIS REPORT IS 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    506689 STERNAL ZIPFIX WITH NEEDLE STERILE/ 5 PACK CERCLAGE FIXATION JDQ SYNTHES BETTLACH 8780284

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR