BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BOLT CUTTER HEAD FOR 5.0MM FIXATION PINS XL

    MDR report key: 3997588 · Received August 10, 2014

    Report

    Report Number
    3003875359-2014-10232
    Event Type
    Malfunction
    Date Received
    August 10, 2014
    Date of Event
    July 10, 2014
    Report Date
    July 14, 2014
    Manufacturer
    SYNTHES HAGENDORF
    Product Code
    FZT
    PMA / PMN Number
    PEXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. ADDITIONAL COMMON DEVICE NAMES: HTZ, FZT. NO NONCONFORMANCE REPORTS WERE GENERATED DURING PRODUCTION. REVIEW OF THE DEVICE HISTORY RECORD SHOWED THAT THERE WERE NO ISSUES DURING THE MANUFACTURE OF THE PRODUCT THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS THE PRODUCT IS ENTERING THE COMPLAINT SYSTEM 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: DEVICE IS AN INSTRUMENT AND IS NOT IMPLANTED/EXPLANTED. A MANUFACTURING EVALUATION WAS COMPLETED: THE DEVICE WAS PRODUCED AND DISTRIBUTED IN OCTOBER 2004. A PIECE OF THE INSTRUMENT AT THE CUTTER HEAD SLEEVE IS BROKEN OFF. THE CUTTER SHOWS SCRATCHES ON THE SURFACE AND VISIBLE WEAR AND TEAR MARKS. THE BROKEN OFF PART IS MISSING. THE MANUFACTURING REVIEW SHOWS THAT THE CORRECT MATERIAL WAS USED AT THE TIME OF THE MANUFACTURING. WE CANNOT DETERMINE THE EXACT ROOT CAUSE OF THIS COMPLAINT. IT IS LIKELY THAT AN INCORRECT POSITIONING OF THE BOLT IN THE CUTTING HEAD CAUSED TOO MUCH TENSION DURING THE CUTTING PROCESS. THIS EVENT IN COMBINATION WITH A HIGH MECHANICAL FORCE APPLICATION COULD FINALLY LEAD TO THE BREAKAGE. BECAUSE OF THE AGE OF THE DEVICE IT IS LIKELY, THAT THE INSTRUMENTS WORKED CORRECTLY WHEN DISTRIBUTED. NO FURTHER INVESTIGATION NEEDED BECAUSE THE DAMAGE WAS CLEARLY CAUSED POST MANUFACTURING. 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

    A PD EVALUATION WAS CONDUCTED. THE REPORT INDICATES THAT THE BOLT CUTTER HEAD FOR IS A COMPONENT OF THE USS FRACTURE SYSTEM INSTRUMENT AND TITANIUM IMPLANT SET. THE USS SYSTEM IS UTILIZED FOR INTERNAL FIXATION FOR VERTEBRAL FRACTURES IN THE THORACOLUMBAR SPINE. THE BOLT CUTTER IS SPECIFICALLY UTILIZED TO CUT THE SHAFTS OF THE SCHANZ SCREWS OFF AFTER FINAL TIGHTENING OF THE ASSEMBLY. THE FOLLOWING DRAWINGS FOR THE INSTRUMENT USED AT THE TIME OF MANUFACTURER WERE REVIEWED. THE DRAWINGS WERE REVIEWED AND FOUND TO BE SUITABLE. THE RECEIVED BOLT CUTTER HEAD WAS FOUND TO HAVE MET THE DRAWING SPECIFICATIONS. THE DEVICE WAS RECEIVED UNDER THE COMPLAINT CATEGORY ¿TIP BROKEN INTRAOPERATIVELY¿. AFTER EXAMINING THE RETURNED INSTRUMENT, THE COMPLAINT CONDITION WAS CONFIRMED, AS APPROXIMATELY ½ OF THE DISTAL END OF THE SLEEVE WAS BROKEN OFF. THE FRACTURE SITE WAS EXAMINED UNDER MAGNIFICATION AND THE MATERIAL WAS FOUND TO BE HOMOGENOUS. ADDITIONALLY NO ISSUES DURING THE MANUFACTURING PROCESS WERE IDENTIFIED DURING THE DEVICE HISTORY RECORD (DHR). A MANUFACTURING EVALUATION WAS UNABLE TO DEFINITIVELY DETERMINE A ROOT CAUSE FOR THE COMPLAINT. THE FAILURE MODE IS CONSISTENT WITH ¿INCORRECT POSITIONING OF THE BOLT IN THE CUTTING HEAD [WHICH] CAUSED TOO MUCH TENSION DURING THE CUTTING PROCESS¿. THIS APPLICATION IN CONJUNCTION WITH A HIGH MECHANICAL FORCE APPLICATION COULD LEAD TO THE FAILURE MODE SEEN IN THIS DEVICE. THE BOLT CUTTING HEAD WAS RECEIVED WITH A BROKEN PORTION OFF THE DISTAL TIP OF THE SLEEVE. NO DESIGN OR MANUFACTURING DEFICIENCIES WERE IDENTIFIED WHICH COULD CONTRIBUTE TO THE COMPLAINT CONDITION OBSERVED IN THE RETURNED DEVICE. NO ROOT CAUSE WAS IDENTIFIED. AS THE CALCULATED OCCURRENCE RATE IS ACCEPTABLE UNDER THE SYSTEM RISK ASSESSMENT, NO ADDITIONAL TASKS ARE REQUIRED. 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 THE SURGEON WAS PERFORMING A POSTERIOR THORACOLUMBAR FUSION ON A PATIENT WITH A THORACOLUMBAR SPINE FRACTURE USING THE TITANIUM USS FRACTURE SYSTEM AND DURING THE FINAL STAGES WHILE CUTTING THE SCHANTZ PINS THE TIP OF THE BOLT CUTTER HEAD BROKE OFF. THE FRAGMENT CAME OFF THE TIP AND SIDE OF THE CUTTER HEAD AND WAS ABOUT 15 X 20MM¿S. THE FRAGMENT WAS RETRIEVED, AND THE SURGEON COMPLETED THE PROCEDURE USING ANOTHER BOLT CUTTER HEAD. THERE WAS NO REPORTED DELAY TO THE PROCEDURE OR FRAGMENTS LEFT IN THE PATIENT THIS IS REPORT 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    474428 BOLT CUTTER HEAD FOR 5.0MM FIXATION PINS XL CUTTER, WIRE FZT SYNTHES HAGENDORF 1296818

    Patients

    Seq Age Sex Outcome Treatment
    1 20 YR