BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BUTTRESS/COMPRESSION NUT FOR 357.369

    MDR report key: 5552878 · Received April 6, 2016

    Report

    Report Number
    2520274-2016-11994
    Event Type
    Malfunction
    Date Received
    April 6, 2016
    Report Date
    March 23, 2016
    Manufacturer
    SYNTHES USA
    Product Code
    HST
    PMA / PMN Number
    PEXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT INVESTIGATION SUMMARY: THE COMPLAINT CONDITION FOR THE BLADE GUIDE SLEEVE (PART 357.369 / LOT 5060074) AND BUTTRESS/COMPRESSION NUT (PART 357.371 / LOT UNKNOWN) WAS LIKELY CAUSED BY NUMEROUS YEARS OF USE AND POSSIBLE ROUGH HANDLING DURING SURGERY OR STERILE PROCESSING. HOWEVER, THIS COMPLAINT IS NOT LIKELY THE RESULT OF ANY DESIGN RELATED DEFICIENCY. THE BLADE GUIDE SLEEVE AND BUTTRESS/COMPRESSION NUT ARE INSTRUMENTS ROUTINELY USED IN THE TITANIUM TROCHANTERIC FIXATION NAIL SYSTEM. THE DEVICES WERE RETURNED AND REPORTED TO HAVE DAMAGED THREADS. THIS CONDITION IS CONFIRMED; THE BUTTRESS/COMPRESSION NUT IS COMPLETELY STUCK AT THE PROXIMAL END OF THE BLADE GUIDE SLEEVE. THE THREADING OF THE BLADE GUIDE SLEEVE SHOWS SOME SEVERELY DEFORMED THREADS. THE NUT IS LIKELY STUCK DUE TO SIMILARLY DEFORMED THREADS ON THE SLEEVE BENEATH THE NUT. IT IS LIKELY THAT NUMEROUS YEARS OF USE AND POSSIBLE ROUGH HANDLING DURING SURGERY OR STERILE PROCESSING LED TO THE COMPLAINT CONDITION. THE SLEEVE WAS MANUFACTURED IN JANUARY, 2006 AND IS OVER TEN (10) YEARS OLD. THE BALANCE OF EACH OF THE RETURNED DEVICES IS IN FAIRLY WORN CONDITION WITH SEVERAL MARKINGS AND OTHER SIGNS OF WEAR. THE RELEVANT DRAWINGS WERE REVIEWED AND DETERMINED TO BE SUITABLE FOR THEIR INTENDED DESIGNS, APPLICATIONS, AND DIMENSIONAL CONFORMITIES WHEN USED AS RECOMMENDED. THE CONDITION OF THE RETURNED DEVICE DOES AGREE WITH THE COMPLAINT DESCRIPTION. WHETHER THE COMPLAINT CONDITION FOR THIS DEVICE CAN BE REPLICATED IS NOT APPLICABLE FOR THIS CONDITION. IT IS LIKELY THAT NUMEROUS YEARS OF USE AND POSSIBLE ROUGH HANDLING DURING SURGERY OR STERILE PROCESSING HAS LED TO THIS COMPLAINT CONDITION. 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.

    Additional Manufacturer Narrative · 1

    (B)(4). DEVICE IS AN INSTRUMENT AND IS NOT IMPLANTED/EXPLANTED. 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. SUBJECT DEVICE HAS NOT BEEN RECEIVED. WITHOUT A LOT NUMBER, THE DEVICE HISTORY RECORD REVIEW AND THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. 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

    DISREGARD VERBIAGE: SUBJECT DEVICE HAS NOT BEEN RECEIVED, TYPO - DEVICE HAS BEEN RECEIVED AND LOT NUMBER NOT WAS NOT PROVIDED. 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

    IT WAS REPORTED BY A SALES CONSULTANT THAT DURING A ROUTINE INSPECTION OF HIS FIELD REQUIREMENT HE NOTICE THAT THE COMPRESSION NUT WOULDN'T LOCK ONTO THE BLADE GUIDE SLEEVE. HE STATED THAT THE THREADS ARE DAMAGED NOT ALLOWING ENGAGEMENT INTO THE AIMING ARM. SALES CONSULTANT CONFIRMS NO PATIENT INVOLVEMENT. THERE ARE 2 DEVICES IN THIS COMPLAINT. THIS REPORT IS 2 OF 2 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    206983 BUTTRESS/COMPRESSION NUT FOR 357.369 TRACTION,APPARATUS,NON-POWERED HST SYNTHES USA

    Patients

    Seq Age Sex Outcome Treatment
    1