BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BLADE GUIDE SLEEVE FOR TROCHANTERIC FIXATION NAILS

    MDR report key: 5552876 · Received April 6, 2016

    Report

    Report Number
    2530088-2016-10099
    Event Type
    Malfunction
    Date Received
    April 6, 2016
    Report Date
    March 23, 2016
    Manufacturer
    SYNTHES BRANDYWINE
    Product Code
    FZX
    PMA / PMN Number
    PEXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL NARRATIVE: 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. UPON REVIEW OF THE DEVICE HISTORY RECORDS, NO NON-CONFORMANCE REPORTS RELEVANT TO THE COMPLAINT CONDITION WERE GENERATED. 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

    NO PATIENT INVOLVEMENT REPORTED. DEVICE IS AN INSTRUMENT AND IS NOT IMPLANTED/EXPLANTED. DATE RETURNED TO MANUFACTURER. 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 HISTORY RECORDS WAS CONDUCTED. THE REPORT INDICATES THAT THE MANUFACTURING LOCATION: (B)(4), INSTRUMENTS MANUFACTURING DATE: 27-JAN-2006 , PART #: 357.369, LOT#: 5060074 (NON-STERILE) - BLADE GUIDE SLEEVE FOR TROCHANTERIC FIXATION NAILS. QUANTITY (B)(4). LOT WAS RELEASE TO THE WAREHOUSE ON 27-JAN-2006. WORK ORDER NO. (B)(4) WAS ISSUED ON 08-AUG-2005 FOR QTY (B)(4). MRR NO: (B)(4) ISSUED ON 03-JAN-2006 FOR FAIL GO GAGE. REVIEW OF THE DEVICE HISTORY RECORD(S) SHOWED THAT THERE WERE NO OTHER ISSUES DURING THE MANUFACTURE OF THE PRODUCT THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. 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 1 OF 2 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    206591 BLADE GUIDE SLEEVE FOR TROCHANTERIC FIXATION NAILS GUIDE FZX SYNTHES BRANDYWINE 5060074

    Patients

    Seq Age Sex Outcome Treatment
    1