BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    2.5MM REAMING ROD WITH BALL TIP/950MM-STERILE

    MDR report key: 5145581 · Received October 13, 2015

    Report

    Report Number
    2520274-2015-16613
    Event Type
    Malfunction
    Date Received
    October 13, 2015
    Date of Event
    September 29, 2015
    Report Date
    September 29, 2015
    Manufacturer
    SYNTHES MONUMENT
    Product Code
    HTO
    PMA / PMN Number
    PEXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT INVESTIGATION SUMMARY: THE COMPLAINT CONDITION FOR THE REAMING ROD (PART 351.706 / LOT 9815358) WAS LIKELY CAUSED BY BENDING THE DEVICE OUTSIDE EXPECTED CONDITIONS; HOWEVER, THIS COMPLAINT IS NOT LIKELY A RESULT OF ANY DESIGN RELATED DEFICIENCY. THE REAMING ROD IS AN INSTRUMENT ROUTINELY USED IN FLEXIBLE REAMERS FOR INTRAMEDULLARY NAILS SYSTEM. THE DEVICE WAS RETURNED AND REPORTED TO HAVE BEEN BROKEN WHILE BENDING PRE-OPERATIVELY. THIS CONDITION IS CONFIRMED; THREE SMALL FRAGMENTS WERE RECEIVED ALONG WITH A SEVERELY BENT REAMING ROD. THE REAMING ROD WAS BENT TO NEARLY A THIRTY DEGREE ANGLE AT APPROXIMATELY HALF THE LENGTH OF THE DEVICE. IT IS LIKELY THAT EXCESSIVE BENDING OUTSIDE EXPECTED CONDITIONS HAS LED TO THIS COMPLAINT CONDITION. THE DEVICE WAS MANUFACTURED IN AUGUST, 2015 AND IS LESS THAN A YEAR OLD. WITH THE EXCEPTION OF THE BEND AND FRAGMENTS, THE BALANCE OF THE RETURNED DEVICE IS NEAR NEW CONDITION WITHOUT ANY OTHER SIGNS OF WEAR. THE ASSOCIATED DRAWING NUMBER WAS REVIEWED AND DETERMINED TO BE SUITABLE FOR THE INTENDED DESIGN, APPLICATION, AND DIMENSIONAL CONFORMITY 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 EXCESSIVE BENDING OUTSIDE EXPECTED CONDITIONS HAS LED TO THIS COMPLAINT CONDITION. DEVICE HISTORY REVIEW: MANUFACTURING LOCATION: (B)(4) ¿ MANUFACTURING DATE: AUGUST 4, 2015 - EXPIRATION DATE: JUNE 30, 2024. 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 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 WAS USED FOR TREATMENT, NOT DIAGNOSIS. DEVICE IS AN INSTRUMENT AND IS NOT IMPLANTED/EXPLANTED. UNKNOWN IF DEVICE IS EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION, BUT HAS YET TO BE RECEIVED. 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A 90 DEGREE REAMING ROD BROKE DURING PREPARATIONS IN THE OPERATING SUITE PRIOR TO THE ONSET OF SURGERY. THE ROD WAS BROKEN WHEN THE SURGICAL STAFF PRACTICED FOR THE UPCOMING SURGERY. RATHER THAN USE THE REAMING ROD TO REAM THE PATIENT'S CANAL, THE SURGEON INTENDED TO USE THE REAMING ROD AS THE WIRE INSIDE AN ANTIBIOTIC NAIL WHICH REQUIRED THE DEVICE TO BE BENT MORE THAN WHEN USED FOR REAMING. IT WAS REPORTED THAT THE SURGEON HAD USED THE DEVICE IN THIS FASHION BEFORE WITH NO ISSUES. DUE TO THE DEVICE BREAKAGE, THE SURGEONS OPTED TO USE ANOTHER NON-SYNTHES DEVICE AND CONTINUED PRE-OPERATIVELY WITH BUILDING THE ANTIBIOTIC NAIL. THERE WERE NO SURGICAL DELAYS OR IMPACT TO THE SURGERY. THEY SURGERY WAS SUCCESSFULLY COMPETED WITH USE OF THE ALTERNATIVE DEVICE; THE PATIENT STATUS AT THE END OF SURGERY IS UNKNOWN. THIS REPORT IS 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    677189 2.5MM REAMING ROD WITH BALL TIP/950MM-STERILE REAMER HTO SYNTHES MONUMENT 9815358

    Patients

    Seq Age Sex Outcome Treatment
    1