BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOLDING SLEEVE-STANDARD FOR MATRIX

    MDR report key: 4120579 · Received September 26, 2014

    Report

    Report Number
    1719045-2014-10472
    Event Type
    Malfunction
    Date Received
    September 26, 2014
    Date of Event
    September 1, 2014
    Report Date
    September 1, 2014
    Manufacturer
    SYNTHES MONUMENT
    Product Code
    LXH
    PMA / PMN Number
    PEXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. DEVICE IS AN INSTRUMENT AND IS NOT IMPLANTED/EXPLANTED. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. 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.

    Additional Manufacturer Narrative · 1

    DEVICE USED FOR TREATMENT, NOT DIAGNOSIS. ADDITIONAL NARRATIVE: A MANUFACTURING EVALUATION WAS PERFORMED. THE THREADED END IS DAMAGED; FRAGMENTS ARE BROKEN OFF BUT NOT INCLUDED WITH THE COMPLAINT. DUE TO AN UNKNOWN CAUSE, THE DRIVER SLEEVE IN QUESTION SEPARATED FROM THE SCREW IN ITS INSERTION. THE SURGEON TRIED USING ANOTHER SCREW, BUT IT ALSO DID NOT WORK. THE OPERATION WAS COMPLETED WITH THE OTHER DRIVER SLEEVE. THE TIP OF FIRST DRIVER SLEEVE WAS BROKEN AND REMAINED IN THE SCREW HEAD. BESIDES, THE SECOND DRIVER SLEEVE WHICH COULD BE INSERTED WAS ALSO BROKEN AT THE TIP AND BROKEN PIECE WAS NOT FOUND. UPON RECEIPT, IT WAS FOUND THAT THE THREADED END IS DAMAGED; FRAGMENTS ARE BROKEN OFF BUT NOT INCLUDED WITH THE COMPLAINT. THE MATERIAL AND DIMENSIONS OF THE PART ARE PER SPECIFICATION EXCEPT FOR THE DAMAGED THREADED TIP. BASED ON THE EVALUATION AND THE UNKNOWN CAUSE, THIS COMPLAINT IS CONSIDERED CONFIRMED BUT IS NOT MANUFACTURING-RELATED. RELEASE TO WAREHOUSE DATES ARE JULY 29, 2011 AND DECEMBER 1, 2011. 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

    AN INVESTIGATION SUMMARY WAS PERFORMED. THE INVESTIGATION OF THE COMPLAINT ARTICLES HAS SHOWN THAT: THE SCREW (04.632.640) HAS NICKS AND SCRATCHES ON THE SURFACE. SOME ANODIZED AREAS ON THE MINOR DIAMETER OF INTERNAL THREAD ON BODY ARE DISAPPEARED. ALSO WE FOUND THAT A BROKEN TIP OF A HOLDING SLEEVE IS STUCK IN THE THREAD. THE HOLDING SLEEVES (03.632.001) WERE FOUND DAMAGED AT THE THREADED END. THE MANUFACTURING REVIEW, OF ALL INVESTIGATED ARTICLES, SHOWS THAT THE PRODUCTION PROCEDURE WAS ACCORDING TO THE SPECIFICATIONS AND THERE WERE NO ISSUES THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. WE ARE NOT ABLE TO DETERMINE THE EXACT CAUSE OF THIS OCCURRENCE AS NO DETAILED CLINICAL INFORMATION IS AVAILABLE. WE CAN ONLY ASSUME THAT THE BREAKAGE WAS CAUSED DUE TO A MECHANICAL OVERLOADING SITUATION DURING USE. THE FOR THE COMPLAINT RELEVANT DIMENSIONS WERE CHECKED AS FAR AS POSSIBLE AND FIND TO BE WITHIN SPECIFICATIONS. THEREFORE WE CAN ONLY ASSUME THAT THE SCREW WORKS CORRECTLY WHEN DISTRIBUTED. WE ARE NOT ABLE TO DETERMINE THE EXACT CAUSE OF THIS OCCURRENCE AS NO DETAILED CLINICAL INFORMATION IS AVAILABLE. 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 DEVICE WAS RECEIVED, THE INVESTIGATION COULD NOT BE COMPLETED, AND NO CONCLUSION COULD BE DRAWN, AS PRODUCT IS ENTERING THE COMPLAINT SYSTEM. A DEVICE HISTORY REVIEW WAS CONDUCTED. THE REPORT INDICATES THAT AVALIGN TECHNOLOGIES-NEMCOMED MANUFACTURED THE HOLDING SLEEVE-STANDARD FOR MATRIX, P/N 03.632.001, AND LOT NUMBER 6611820 ON PO #1248667 FOR 3 PIECES DATED JUNE 27, 2011. INITIALLY, THE PART CONFORMED TO THE CERTIFICATE OF COMPLIANCE, DATED JUNE 24, 2011, AND WAS SCRAPPED AT FINAL INSPECTION FOR PRODUCT DEVELOPMENT EVALUATION. 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 (B)(4) REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THE DRIVER SLEEVE SEPARATED FROM THE SCREW DURING INSERTION, THE SURGEON TRIED USING ANOTHER SCREW, BUT IT ALSO DID NOT WORK. THE OPERATION WAS COMPLETED WITH ANOTHER DRIVER SLEEVE. THE TIP OF THE FIRST DRIVER SLEEVE WAS BROKEN AND REMAINED IN THE SCREW HEAD. THE SECOND DRIVER SLEEVE WHICH COULD BE INSERTED WAS ALSO BROKEN AT THE TIP AND BROKEN PIECE WAS NOT FOUND. THE TIP OF THE SECOND SCREW WAS RECESSED YET NO BROKEN SCREWS WERE FOUND AND IT WAS CONFIRMED THROUGH X-RAY THAT THE SCREW WAS NOT IN THE PATIENTS BODY. NO SURGICAL DELAY WAS REPORTED OR ANY PATIENT HARM DUE TO THIS EVENT. THIS IS REPORT 2 OF 2 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    600449 HOLDING SLEEVE-STANDARD FOR MATRIX MISC ORTHO SURGICAL INSTR LXH SYNTHES MONUMENT 6611820

    Patients

    Seq Age Sex Outcome Treatment
    1