BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOOK OR SCREW HOLDER

    MDR report key: 3070551 · Received April 22, 2013

    Report

    Report Number
    3003787298-2013-10080
    Event Type
    Malfunction
    Date Received
    April 22, 2013
    Report Date
    September 12, 2011
    Manufacturer
    SYNTHES JENNERSVILLE
    Product Code
    LXH
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    SYNTHES IS SUBMITTING THIS REPORT AS A RESULT OF REMEDIATION ACTIVITIES RELATED TO FDA WARNING LETTER DATED FEBRUARY 2012. DEVICE(S) LISTED IN THIS REPORT IS (ARE) USED FOR TREATMENT, NOT DIAGNOSIS. ANY ADDITIONAL INFORMATION RECEIVED REGARDING THIS EVENT AFTER FILING THIS REPORT SHALL BE FILED ON A SUPPLEMENTAL MDR. MANUFACTURING EVALUATION REPORTS THAT THE PART WAS RECEIVED. THE DEVICE IS COMPRISED OF 2 PIECES THAT CAN BE SEPARATED FROM EACH OTHER AND ARE IDENTIFIED AS STEM AND SLEEVE. THE THREADED PORTION BROKEN OFF THE STEM. THE STEM WAS REVIEWED FOR THIS COMPLAINT. THE SLEEVE WAS NOT DAMAGED AND ASSEMBLED WITH THE STEM AS REQUIRED. THE STEM COMPONENT MEETS ALL THE MANUFACTURING SPECIFICATIONS REVIEWED. A REVIEW OF THE DEVICE HISTORY RECORD DID NOT SHOW CONDITIONS THAT COULD HAVE CONTRIBUTED TO THE REPORTED EVENT PRODUCT DEVELOPMENT EVENT EVALUATION REVEALS, AS THIS INSTRUMENT IS USED AS ON OF THE OPTIONS FOR FINAL TIGHTENING A PEDICLE SCREW IT IS POSSIBLE FOR THIS INSTRUMENT TO SEE EXTREMELY HIGH, OR OFF AXIS LOADS DURING TIGHTENING. WHEN USED PROPERLY THE SLOTTED TABS ON THE INSTRUMENT/IMPLANT INTERFACE WILL WITH STAND THOSE LOADS. IF THE THREADS BROKE OFF DURING TIGHTENING IT IS LIKELY THAT THIS INSTRUMENT WAS NOT FULLY LOCKING INTO THE IMPLANT AND SEVERE AND/OR OFF AXIS LOADS WERE APPLIED. IT IS NOT CLEAR WHAT INSTRUMENTS WERE USED TO COMPLETE THIS TIGHTENING. FROM A DESIGN STAND POINT, THIS INSTRUMENT IS APPROPRIATE FOR THE USE FOR WHICH IT IS RECOMMENDED. THIS COMPLAINT IS DEEMED INDETERMINATE.

    Additional Manufacturer Narrative · 1

    SYNTHES IS SUBMITTING THIS REPORT AS A RESULT OF REMEDIATION ACTIVITIES RELATED TO FDA WARNING LETTER DATED FEBRUARY 2012. DEVICE(S) LISTED IN THIS REPORT IS (ARE) USED FOR TREATMENT, NOT DIAGNOSIS. ANY ADDITIONAL INFORMATION RECEIVED REGARDING THIS EVENT AFTER FILING THIS REPORT SHALL BE FILED ON A SUPPLEMENTAL MDR. ADDITIONAL INFORMATION: ORIGINAL AWARENESS DATE IS (B)(6) 2011. PLACEHOLDER.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING SCREW INSERTION, THE TIP OF THE GUIDE STICK BROKE OFF INTO THE HEAD OF THE SCREW. THE SURGEON USED ANOTHER INSTRUMENT TO REMOVE THE SCREW, ANOTHER GUIDE STICK AND NEW SCREW WAS USED TO COMPLETE THE PROCEDURE WITHOUT FURTHER INCIDENT. NO FRAGMENTS REMAINED IN THE PATIENT.

    Description of Event or Problem · 1

    THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    171889 HOOK OR SCREW HOLDER LXH SYNTHES JENNERSVILLE 6082131

    Patients

    Seq Age Sex Outcome Treatment
    1