BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BUTTRESS/COMPRESSION NUT FOR 357.369

    MDR report key: 5135543 · Received October 8, 2015

    Report

    Report Number
    2520274-2015-16496
    Event Type
    Malfunction
    Date Received
    October 8, 2015
    Date of Event
    September 27, 2015
    Report Date
    September 28, 2015
    Manufacturer
    SYNTHES MONUMENT
    Product Code
    HST
    PMA / PMN Number
    PEXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE HISTORY RECORD REVIEW FOR PART 357.371, SYNTHES LOT 6064459/SUPPLIER LOT TI01759: RELEASE TO WAREHOUSE DATE: 15JANUARY2009. SUPPLIER- TROUTMAN INDUSTRIES INC. NO NON-CONFORMANCE REPORTS 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. 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

    AN INVESTIGATION SUMMARY WAS PERFORMED. THE INVESTIGATION OF THE COMPLAINT ARTICLES HAS SHOWN THAT:THE COMPLAINT CONDITION FOR THE 357.377 LOT NUMBER 6606044 HELICAL BLADE COUPLING SCREW, 357.371 LOT NUMBER TI01759 BUTTRESS/COMPRESSION NUT, AND 357.369 LOT NUMBER 6320172 BLADE GUIDE SLEEVE WAS LIKELY CAUSED BY EXCESSIVE AND OFF ANGLE MALLETING DURING SURGERY; HOWEVER, THIS COMPLAINT IS NOT LIKELY A RESULT OF ANY DESIGN RELATED DEFICIENCY. IT IS LIKELY THAT THE INNER THREADING OF THE BUTTRESS/COMPRESSION NUT OR THE THREADING OF THE BLADE GUIDE SLEEVE HAS BECOME DEFORMED CAUSING THE DEVICES TO STICK TOGETHER LEADING TO THIS COMPLAINT CONDITION. NO PRODUCT ISSUE WAS ALLEGED OR IDENTIFIED UPON EXAMINATION OF THE RETURNED 357.372 LOT NUMBER 6510303 HELICAL BLADE INSERTER. THIS INVESTIGATION SUMMARY IS APPROVED. LOT NUMBER DISCOVERED TO BE TI01759, WAS THE CORRECT, VALID LOT NUMBER.. 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

    SUBJECT DEVICE HAS BEEN RECEIVED AND IS CURRENTLY IN THE EVALUATION PROCESS. INVESTIGATION IS ONGOING; NO CONCLUSION COULD BE DRAWN AS PRODUCT IS ENTERING THE COMPLAINT SYSTEM. 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/EXPLANTED. COMPLAINANT PART IS EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION, BUT HAS YET TO BE RECEIVED. (B)(6). WITHOUT A VALID LOT NUMBER THE DEVICE HISTORY RECORDS REVIEW COULD NOT BE COMPLETED. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. 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) REPORTED A HELICAL BLADE COUPLING SCREW BROKE DURING A PROXIMAL FEMORAL FRACTURE. THE PROXIMAL END OF THE COUPLING SCREW BROKE AS THE SURGEON WAS HAMMERING IN THE HELICAL BLADE; BOTH PIECES WERE ACCOUNTED FOR; NO FRAGMENTS WERE GENERATED, AND NONE OF THE PIECES FELL INTO THE PATIENT. AS A RESULT OF THE COUPLING SCREW BREAKING, IT WAS NECESSARY TO MALLET ON THE BLADE GUIDE SLEEVE AND THE BUTTRESS/COMPRESSION NUT TO BACK OUT THE HELICAL BLADE THUS, DISCONNECTING THE BROKEN CONNECTING SCREW. BOTH PARTS WERE DAMAGED BEYOND REPAIR. THE SURGEON SUCCESSFULLY REMOVED THE HELICAL BLADE FROM THE BROKEN HELICAL BLADE COUPLING SCREW, PRIOR TO INSERTING A NEW ONE. THERE WAS NO REPORTED HARM TO THE PATIENT. THERE WAS NO SURGICAL DELAY REPORTED. THIS IS REPORT 2 OF 4 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    666946 BUTTRESS/COMPRESSION NUT FOR 357.369 TRACTION, APPARATUS, NON-POWERED HST SYNTHES MONUMENT TI01759

    Patients

    Seq Age Sex Outcome Treatment
    1