BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CABLE TENSIONER

    MDR report key: 4840331 · Received June 12, 2015

    Report

    Report Number
    1719045-2015-10376
    Event Type
    Malfunction
    Date Received
    June 12, 2015
    Report Date
    May 27, 2015
    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

    A DEVICE EVALUATION INVESTIGATION WAS PERFORMED: OUR INVESTIGATION SHOWS THAT IN THE INTERIOR OF THE INSTRUMENT A COUPLE OF RESIDUES (SINGLE STRANDS) OF A CABLE TO WOUND AROUND THE JAWS. MANUFACTURING AND INSPECTION RECORDS INDICATED NO PROBLEMS WITH THE LOT IN QUESTION (MANUFACTURED AUGUST 2011). THE FAILURE IS INDICATIVE OF INCORRECT MANIPULATION. IT IS NOTED WITHIN THE OP INSTRUCTIONS. "...TURN THE FLUTED KNOB AT THE END OF THE TENSIONER COUNTERCLOCKWISE AS FAR AS POSSIBLE, THUS THE INSERTION / REMOVAL OF THE CABLE IS GUARANTEED". FURTHER, WE CAN ONLY ASSUME THAT THIS INSTRUMENT WAS USED OFTEN WHICH CONTRIBUTES AS ANOTHER REASON FOR THE REPORTED PROBLEM (WEAR AND TEAR). 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.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 IS AN INSTRUMENT AND IS NOT IMPLANTED OR EXPLANTED. THE DEVICE WAS RECEIVED AT A DEPUY SYNTHES FACILITY IN (B)(4) ON AN UNKNOWN DATE. AT THIS TIME, THE DEVICE HAS NOT BE RECEIVED BY THE INVESTIGATING LOCATION. (B)(4). ADDITIONAL MANUFACTURING RELEASE DATES: AUGUST 24, 2011 SUBJECT DEVICE HAS BEEN RECEIVED BY A SYNTHES FACILITY, BUT IS STILL PENDING FOR RECEIPT AT THE INVESTIGATION SITE. THE EVALUATION HAS NOT YET BEGUN. DEVICE HISTORY REVIEW: PIONEER SURGICAL TECHNOLOGIES MANUFACTURED THE CABLE TENSIONER (PART 391.201 / LOT P1099483). THERE WERE THREE DEVICE HISTORY RECORDS (DHR) TO REVIEW: PURCHASE ORDER (PO) DATED (B)(4) 2011 FOR (B)(4) PARTS - THE PRODUCT CONFORMED TO ALL REQUIREMENTS AS INDICATED IN THE CERTIFICATE OF CONFORMANCE DATED (B)(4) 2011. THE LOT WAS INSPECTED AND CONFORMED TO THE SYNTHES INCOMING FINAL INSPECTION SHEET. THERE WERE NO MATERIAL RECORD REPORTS (MRR), NON-CONFORMANCE REPORTS (NCR), OR COMPLAINT-RELATED ISSUES WITH THIS LOT. (B)(4) PARTS WERE RELEASED TO THE WAREHOUSE ON (B)(4) 2011. PO DATED (B)(4) 2011 FOR (B)(4) PARTS - THE PRODUCT CONFORMED TO ALL REQUIREMENTS AS INDICATED IN THE CERTIFICATE OF CONFORMANCE DATED (B)(4) 2011. THE LOT WAS INSPECTED AND CONFORMED TO THE SYNTHES INCOMING FINAL INSPECTION SHEET. THERE WERE NO MRRS, NCRS, OR COMPLAINT-RELATED ISSUES WITH THIS LOT. (B)(4) PARTS WERE RELEASED TO THE WAREHOUSE ON (B)(4) 2011. PO DATED AUGUST 23, 2011 FOR 2 PARTS. THE PRODUCT CONFORMED TO ALL REQUIREMENTS AS INDICATED IN THE CERTIFICATE OF CONFORMANCE DATED AUGUST 19, 2011. THE LOT WAS INSPECTED AND CONFORMED TO THE SYNTHES INCOMING FINAL INSPECTION SHEET. THERE WERE NO MRRS, NCRS, OR COMPLAINT-RELATED ISSUES WITH THIS LOT. TWO (2) PARTS WERE RELEASED TO THE WAREHOUSE ON AUGUST 24, 2011. 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.

    Description of Event or Problem · 1

    DEVICE REPORT FROM SYNTHES EUROPE REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT A CABLE IS STUCK IN THE CABLE TENSIONER AND CANNOT BE REMOVED. 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
    385062 CABLE TENSIONER MISC ORTHO SURGICAL INSTR LXH SYNTHES MONUMENT P099483

    Patients

    Seq Age Sex Outcome Treatment
    1