BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LARGE BUTTRESS/COMPRESSION NUT FOR BLADE GUIDE SLEEVE TFN

    MDR report key: 3864040 · Received June 10, 2014

    Report

    Report Number
    3003787298-2014-10026
    Event Type
    Malfunction
    Date Received
    June 10, 2014
    Date of Event
    April 12, 2014
    Report Date
    April 12, 2014
    Manufacturer
    SYNTHES BRANDYWINE
    Product Code
    HST
    PMA / PMN Number
    PEXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE USED FOR TREATMENT, NOT DIAGNOSIS. DEVICE IS AN INSTRUMENT AND IS NOT IMPLANTED/EXPLANTED. SUBJECT DEVICE HAS BEEN RECEIVED AND IS CURRENTLY IN THE EVALUATION PROCESS. A REVIEW OF THE DEVICE HISTORY RECORD 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 WAS USED FOR TREATMENT, NOT DIAGNOSIS. ADDITIONAL NARRATIVE: AN EVALUATION WAS PERFORMED ON THE RETURNED DEVICE. AS PER RECEIVED CONDITION OF DEVICE SHOWS; THE LARGE BUTTRESS/COMPRESSION NUT, PART # SD357.371, WAS RECEIVED STUCK ON THE BLADE GUIDE SLEEVE. THERE ARE HAMMER DENTS AND SURFACE SCRATCHES OVER THE DEVICE. THE BALANCE IS IN GOOD CONDITION AND THE ETCHINGS ARE LEGIBLE. 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

    REVIEW OF THE DEVICE HISTORY RECORD SHOWS THAT THERE WERE NO ISSUES DURING THE MANUFACTURING OF THE PRODUCT THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION.(B)(4).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

    ADDITIONAL NARRATIVE: A PRODUCT DEVELOPMENT EVALUATION WAS COMPLETED: ONE 11.0MM/8.0MM PROTECTION SLEEVE, ONE LARGE BUTTRESS/COMPRESSION NUT, ONE BLADE GUIDE SLEEVE, AND ONE 130 DEGREE AIMING ARM WERE RECEIVED. THE RETURNED PROTECTION SLEEVE WAS RECEIVED WITH SURFACE SCRATCHES OVER THE WORKING LENGTH AND DENTS ON THE CIRCUMFERENCE OF THE PROXIMAL END. THE RETURNED AIMING ARM WAS RECEIVED INTACT WITH SIGNIFICANT DENTS TO THE SIDE THAT MATES WITH THE INSERTION HANDLE AND SMALLER DENTS OVER THE REMAINDER OF THE DEVICE. THE BUTTRESS/COMPRESSION NUT AND BLADE GUIDE SLEEVE WERE RECEIVED STUCK TOGETHER. BOTH SHOW DENTS AND SCRATCHES. THE BLADE GUIDE SLEEVE HAS DAMAGE TO THE THREADS SUCH THAT A FEW HAVE BEEN FLATTENED AND THERE ARE DENTS ON THE PROXIMAL END NEXT TO THE GROOVES INTENDED TO MATE WITH THE HELICAL BLADE INSERTER. THE COMPLAINT CONDITION CANNOT BE REPLICATED AS THE BLADE GUIDE SLEEVE AND BUTTRESS/COMPRESSION NUT ARE ALREADY JAMMED AND THE BLADE GUIDE SLEEVE, PROTECTION SLEEVE, AND AIMING ARM DO NOT JAM TOGETHER. THUS, THE PORTION OF THE COMPLAINT CONDITION FOR THE BUTTRESS/COMPRESSION NUT AND BLADE GUIDE SLEEVE JAMMING IS CONFIRMED BUT THE PORTION OF THE COMPLAINT CONDITION FOR THE BLADE GUIDE SLEEVE, PROTECTION SLEEVE, AND AIMING ARM JAMMING IS UNCONFIRMED. THE RETURNED CONDITION OF THESE DEVICES SHOWS EVIDENCE THAT REPEATED HAMMERING BLOWS, INCONSISTENT WITH THE SPECIFIED TECHNIQUE, HAVE CAUSED THE COMPLAINT CONDITION. THERE ARE NUMEROUS SUBSTANTIAL HAMMER MARKS ON THE PROTECTION SLEEVE, AIMING ARM, BLADE GUIDE SLEEVE, AND COMPRESSION NUT, ALL OF WHICH ARE NOT SPECIFIED TO BE HAMMERED. HAMMER BLOWS WOULD RESULT IN THE DAMAGED THREADS THAT HAVE LOCKED THE COMPRESSION NUT ONTO THE BLADE GUIDE SLEEVE. THEREFORE, IT IS LIKELY THAT THE METHOD OF USE HAS LED TO THIS COMPLAINT. THE RELEVANT DESIGN DRAWINGS WERE REVIEWED. THE DESIGNS WERE ALL FOUND TO BE SUFFICIENT FOR THEIR INTENDED USE AND THE DESIGN HISTORY DID NOT IMPACT THE COMPLAINT CONDITION. THEREFORE, THIS COMPLAINT CONDITION IS NOT THE RESULT OF A DESIGN DEFICIENCY. IN CONCLUSION, THE COMPLAINT CONDITION OF THE BUTTRESS/COMPRESSION NUT AND BLADE GUIDE SLEEVE JAMMING HAS BEEN CONFIRMED. HOWEVER, THE COMPLAINT CONDITION FOR THE BLADE GUIDE SLEEVE, PROTECTION SLEEVE, AND AIMING ARM JAMMING IS UNCONFIRMED. IT APPEARS THE METHOD OF USE RESULTED IN THIS COMPLAINT RATHER THAN ANY DESIGN DEFICIENCIES. THE DESIGNS FOR THESE DEVICES ARE DETERMINED TO BE SUITABLE FOR THEIR INTENDED USE. 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 THAT DURING A HIP FRACTURE PROCEDURE, THE AIMING ARM ALONG WITH THE DRILL SLEEVE /BLADE SLEEVE WERE FUSED. THE SURGEON USED A INSERTION HANDLE TO BE HIT WITH A HAMMER IN ORDER TO REMOVE STUCK AIMING ARM, DRILL SLEEVE AND BLADE SLEEVE. AFTER THE SURGERY THE DEVICES WERE INSPECTED BY THE SURGEON AND IT WAS DISCOVERED THAT BY HAMMERING ON THE INSERTION HANDLE TO FREE THE OTHER DEVICES, THE AIMING ARM, DRILL SLEEVE AND BLADE SLEEVE BECAME DAMAGED. THE SURGERY WAS COMPLETED, SUCCESSFULLY, WITH APPROXIMATELY 5-10 MINUTE DELAY. THERE WAS REPORTEDLY NO HARM TO THE PATIENT. THIS REPORT IS FOR PART SD357.371 WHICH IS ATTACHED TO (B)(4) FOR (B)(4).

    Description of Event or Problem · 1

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

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    340753 LARGE BUTTRESS/COMPRESSION NUT FOR BLADE GUIDE SLEEVE TFN TRACTION,APPARATUS,NON-POWERED HST SYNTHES BRANDYWINE 6083065

    Patients

    Seq Age Sex Outcome Treatment
    1 90 YR