BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOLDING SLEEVE-LONG FOR MATRIX

    MDR report key: 4180680 · Received October 17, 2014

    Report

    Report Number
    1719045-2014-10516
    Event Type
    Malfunction
    Date Received
    October 17, 2014
    Date of Event
    September 4, 2014
    Report Date
    September 22, 2014
    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 HISTORY REVIEW WAS CONDUCTED. THE REPORT INDICATES THAT MAGNUM MANUFACTURING CENTER MANUFACTURED THE HOLDING SLEEVE LONG FOR MATRIX, P/N 03.632.036, AND LOT NUMBER 6565177 ON PO #1229143, FOR (B)(4) PIECES DELIVERED APRIL 26, 2011. INITIALLY, THE PART CONFORMED TO THE SUPPLIER¿S CERTIFICATE OF CONFORMANCE, DATED APRIL 22, 2011, AND SYNTHES FINAL INSPECTION SHEET # NS035211, REVISION ¿L¿. THE PARTS WERE RELEASED TO THE WAREHOUSE ON APRIL 27, 2011. THERE WERE NO MRR¿S, NCR¿S, OR COMPLAINT RELATED ISSUES WITH THIS LOT. THE HOLDING SLEEVE LONG FOR MATRIX WAS MADE TO THE SYNTHES DRAWING P/N 03.632.001, REVISION ¿G¿, RELEASED ON SEPTEMBER 17, 2010. 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. DEVICE IS AN INSTRUMENT AND IS NOT IMPLANTED/EXPLANTED. THE VISUAL INSPECTION OF THE RETURNED DEVICE PERFORMED AS PART OF THE MANUFACTURING INVESTIGATION REPORTED THE THREAD AT THE TIP DISTAL IS BROKEN. THE INVESTIGATION OF THE COMPLAINED RETAINING SLEEVE SHOWS THAT A PART OF THE PITCH FROM THREAD DISTAL BROKEN OFF. FURTHER INVESTIGATION OF DOCUMENTATION FOR PRODUCTION AND MATERIAL SHOWS CONFORMITY FOR THE PRODUCT MANUFACTURED IN APRIL 2011. WITHOUT FURTHER DETAILS IT IS NOT POSSIBLE TO DETERMINE THE EXACT CAUSE OF THIS OCCURRENCE . THE COMPLAINT CONDITION IS LIKELY THE RESULT OF A SHORT MECHANICAL OVERLOAD CAUSED THIS DAMAGE DURING SCREW INSERTION. THESE FORCES CAN BE THE RESULT OF, AS FOR EXAMPLE, STRONG SOFT TISSUE PUSH OR EXCESSIVE CORRECTION OF THE SCREW TRAJECTORY. THESE FORCES MAY OVERSTRESS THE MATERIAL WITH SUBSEQUENT FAILURE OF THE TIP OF THE RETAINING SLEEVE. ALTERNATIVELY THE CONNECTION BETWEEN RETAINER CARTRIDGE AND BONE SCREW COULD BE ACCIDENTALLY PARTIALLY DETACHED BY HOLDING THE GREEN KNOB WITHIN SCREWING. SYNTHES PROVIDES WITH THE LOCKABLE RETAINER CARTRIDGE (B)(4) AN ALTERNATIVE INSTRUMENT WHICH CAN BE USED TO HOLD ON THE KNOB BY SCREWING. A REVIEW OF THE DEVICE HISTORY RECORDS HAS BEEN REQUESTED. 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 THE THREAD AT THE DISTAL TIP OF THE HOLDING SLEEVE INSTRUMENT WAS BROKEN. ANOTHER INSTRUMENT WAS USED TO COMPLETE THE PROCEDURE, SURGERY WAS NOT EXTENDED DUE TO THE INCIDENT AND IT WAS REPORTED THERE WAS NO PATIENT HARM THIS IS REPORT 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    662722 HOLDING SLEEVE-LONG FOR MATRIX ORTHOPEDIC MANUAL SURGICAL INSTRUMENT LXH SYNTHES MONUMENT 6565177

    Patients

    Seq Age Sex Outcome Treatment
    1