BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CABLE TENSIONER

    MDR report key: 6244111 · Received January 11, 2017

    Report

    Report Number
    1719045-2017-10014
    Event Type
    Malfunction
    Date Received
    January 11, 2017
    Date of Event
    December 12, 2016
    Report Date
    December 20, 2016
    Manufacturer
    SYNTHES MONUMENT
    Product Code
    LXH
    UDI-DI
    10886982198204
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    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 USED FOR TREATMENT, NOT DIAGNOSIS. DEVICE IS EXPECTED TO BE RETURNED TO SYNTHES MANUFACTURER FOR EVALUATION /INVESTIGATION, BUT HAS YET TO BE RECEIVED. (B)(6). DEVICE HISTORY RECORDS REVIEW WAS CONDUCTED. THE REPORT INDICATES THAT: DHR REVIEW FOR: PART #391.201, LOT #P202935, RELEASE TO WAREHOUSE DATE: 03APR2015, EXPIRATION DATE: NA, SUPPLIER: (B)(4). 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. 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 PRODUCT INVESTIGATION WAS COMPLETED: OUR INVESTIGATION SHOWED THAT A CABLE IS COMPLETELY JAMMED IN THE CABLE TENSIONER. ALSO IT IS VISIBLE THAT SEVERAL CORDS FROM THE CABLE ARE JAMMED IN THE GRIPPING MECHANISM (CLAMPING JAWS). WHEN WE TURN THE FLUTED KNOB AT THE END OF THE TENSIONER COUNTERCLOCKWISE THE CABLE COULD NOT BE REMOVED EVEN WITH MUCH FORCE. MANUFACTURING AND INSPECTION RECORDS INDICATED NO PROBLEMS WITH THE LOT IN QUESTION. THE OCCURRENCE WAS LIKELY CAUSED BY AN INCORRECT MANIPULATION BY THE USER. COMPLAINT IS DISPOSED AS CONFIRMED DUE TO EVIDENCE THAT ON CABLE IS JAMMED, BUT IT'S CONSIDERED NOT VALID FOR MANUFACTURING STANDPOINT BECAUSE THERE IS NO EVIDENCE OF ISSUES MANUFACTURING RELATED. NO INDICATION FOR PRODUCT RELATED ISSUE WAS FOUND. 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 ON AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT A CABLE CANNOT BE REMOVED FROM THE CABLE TENSIONER AFTER SURGERY ON (B)(6) 2016. THERE WAS NO PATIENT INVOLVEMENT. COMPLAINT INVOLVES 1 PART. REPORTED CONCOMITANT DEVICES: CABLE (PART / LOT: UNKNOWN, QUANTITY: 1). THIS REPORT IS 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    22995 CABLE TENSIONER MISC ORTHO SURGICAL INSTRUMENT LXH SYNTHES MONUMENT P202935 10886982198204

    Patients

    Seq Age Sex Outcome Treatment
    1 CABLE (PART / LOT: UNKNOWN, QUANTITY: 1)