BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CABLE TENSIONER

    MDR report key: 5562739 · Received April 8, 2016

    Report

    Report Number
    1719045-2016-10300
    Event Type
    Malfunction
    Date Received
    April 8, 2016
    Report Date
    March 17, 2016
    Manufacturer
    SYNTHES MONUMENT
    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

    SERVICE AND REPAIR EVALUATION WAS PERFORMED. THE INVESTIGATION OF THE COMPLAINT ARTICLES HAS SHOWN THAT: THE CUSTOMER REPORTED THE TENSIONER WOULD NOT RELEASE THE CABLE. THE CAUSE OF THE ISSUE IS UNKNOWN. THE DEVICE WAS SENT TO THE VENDOR FOR REPAIR ON 11-APR-2016. THE VENDOR LUBRICATED THE INTERNAL SPRING AND RECALIBRATED THE DEVICE. THE VENDOR REPAIRED THE DEVICE PER THE VENDOR WORK INSTRUCTIONS. THE DEVICE WILL BE RETURNED TO THE CUSTOMER UPON COMPLETION OF THE SERVICE AND REPAIR PROCESS. THE COMPONENT WAS RE-CALIBRATED AND TESTED TO OPERATIONAL SPECIFICATIONS AND RETURNED TO THE CUSTOMER. NO CAUSE WAS OBSERVED; NO MANUFACTURING OR DESIGN ISSUES WERE NOTED. NO CORRECTIVE ACTION IS REQUIRED AT THIS TIME. THE EVALUATION WAS CONFIRMED. 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

    SUBJECT DEVICE HAS BEEN RECEIVED AND IS CURRENTLY IN THE EVALUATION PROCESS. INVESTIGATION IS ONGOING; 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.

    Additional Manufacturer Narrative · 1

    THE RESULTS OF THE DEVICE AND SERVICE HISTORY RECORD REVIEWS FOR BOTH OF THE POTENTIAL LOT NUMBERS WERE PROVIDED ON THE INITIAL MEDWATCH. NOW THAT THE MALFUNCTIONING DEVICE HAS BEEN IDENTIFIED, THE FOLLOWING ARE THE APPLICABLE RESULTS: DEVICE HISTORY RECORD REVIEW: RELEASE TO WAREHOUSE DATE: AUGUST 17, 2009. NO NON-CONFORMANCE REPORTS 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. SERVICE HISTORY RECORD REVIEW: NO SERVICE HISTORY REVIEW CAN BE PERFORMED AS PART 391.201 / LOT P053503 IS A LOT/BATCH CONTROLLED ITEM. THE MANUFACTURE DATE OF THIS ITEM IS AUGUST 17, 2009. THE SOURCE OF THE MANUFACTURE DATE IS THE RELEASE TO WAREHOUSE DATE. THE SERVICE HISTORY REVIEW IS UNCONFIRMED. 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

    PATIENT INFORMATION IS UNKNOWN. LOT NUMBERS P053504 AND P053503 PROVIDED; IT IS UNKNOWN WHICH DEVICE IS THE COMPLAINED DEVICE. (B)(4). 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. A SERVICE HISTORY REVIEW FOR BOTH POTENTIAL LOT NUMBERS WAS COMPLETED: NO SERVICE HISTORY REVIEW CAN BE PERFORMED AS PART NUMBER 391.201 WITH LOT NUMBER P053504 IS A LOT/BATCH CONTROLLED ITEM. THE MANUFACTURE DATE OF THIS ITEM IS JULY 31, 2009. THE SOURCE OF THE MANUFACTURE DATE IS THE RELEASE TO WAREHOUSE DATE. THE SERVICE HISTORY REVIEW IS UNCONFIRMED. NO SERVICE HISTORY REVIEW CAN BE PERFORMED AS PART NUMBER 391.201 WITH LOT NUMBER P053503 IS A LOT/BATCH CONTROLLED ITEM. THE MANUFACTURE DATE OF THIS ITEM IS AUGUST 17, 2009. THE SOURCE OF THE MANUFACTURE DATE IS THE RELEASE TO WAREHOUSE DATE. THE SERVICE HISTORY REVIEW IS UNCONFIRMED. A DEVICE HISTORY RECORD REVIEW FOR BOTH POTENTIAL LOT NUMBERS WAS COMPLETED: PART 391.201, LOT P053504: MANUFACTURING LOCATION: SUPPLIER - (B)(4). MANUFACTURING DATE: JULY 31, 2009. NO NON-CONFORMANCE REPORTS 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. PART 391.201, LOT P053503: RELEASE TO WAREHOUSE DATE: AUGUST 17, 2009. MANUFACTURING SITE IS (B)(4). NO NON-CONFORMANCE REPORTS 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.

    Description of Event or Problem · 1

    UPDATE: IT WAS CONFIRMED THAT THE MALFUNCTIONING DEVICE WAS PART 391.201 / LOT P053503.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN INITIAL TROCHANTERIC FIXATION NAIL-ADVANCED (TFN-A) IMPLANT PROCEDURE TO TREAT A FRACTURED FEMUR, THE CABLE TENSIONER DID NOT RELEASE THE CABLE. THE SURGEON WAS NOT ABLE TO RELEASE THE CABLE AND THEREFORE CUT THE CABLE FROM THE TENSIONER. THERE WAS A TWO MINUTE SURGICAL DELAY. A BACKUP TENSIONER WAS AVAILABLE AND THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THE PATIENT OUTCOME WAS REPORTED AS STABLE. THE TENSIONER WAS SENT TO STERILE PROCESSING WHERE THE CABLE WAS RELEASED. THE TENSIONER WAS PLACED BACK IN THE TRAY, ALONGSIDE A SECOND TENSIONER. IT IS UNKNOWN WHICH OF THE TWO TENSIONERS IN THE TRAY MALFUNCTIONED. THIS IS REPORT 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    219909 CABLE TENSIONER MISC ORTHO SURGICAL INSTR LXH SYNTHES MONUMENT P053503

    Patients

    Seq Age Sex Outcome Treatment
    1