BEUDAMED
    FDA Adverse Event Injury Summary report: N

    5.0MM FLEXIBLE SHAFT

    MDR report key: 4799392 · Received May 27, 2015

    Report

    Report Number
    9612488-2015-10295
    Event Type
    Injury
    Date Received
    May 27, 2015
    Date of Event
    May 4, 2015
    Report Date
    May 5, 2015
    Manufacturer
    SYNTHES BETTLACH
    Product Code
    HTO
    PMA / PMN Number
    PEXEMPT
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. ADDITIONAL NARRATIVE: A PRODUCT DEVELOPMENT INVESTIGATION WAS PERFORMED FOR THE SUBJECT DEVICE (PART NUMBER 352.040, LOT NUMBER 7771080, 5.0MM FLEXIBLE SHAFT). THE SUBJECT DEVICE WAS RETURNED WITH THE COMPLAINT CONDITION OF ¿WHILE REAMING THE PROXIMAL TIBIA WITH THE FLEXIBLE REAMING SHAFT (352.040 LOT 7771080 MANUFACTURING DATE 2/2012) AND 13MM REAMING BIT UNDER POWER, THE REAMING BIT BROKE APART AND THE REAMING SHAFT WAS DEFORMED WHERE THE BIT ATTACHED, IN THE MEDULLARY CANAL OF THE TIBIA. REAMING SHAFT WAS REMOVED. ATTEMPTED REMOVAL OF FRAGMENTS FROM THE REAMING BIT WAS SUCCESSFUL FOR THE MOST PART, HOWEVER NOT COMPLETELY. THE ATTEMPT TO RETRIEVE THE BROKEN PART CAUSED A SURGICAL DELAY BUT THE ACTUALLY TIME DELAY IS UNKNOWN." THE ASSOCIATED REAMER HEAD WAS NOT RETURNED. THE RETURNED INSTRUMENT WAS EVALUATED AND THE COMPLAINT CONDITION OF DEFORMED WAS ABLE TO BE CONFIRMED AS THE PRONGS ON THE DISTAL TIP OF THE INSTRUMENT WERE TWISTED. THE DEFORMATION IS CONSISTENT WITH WHAT WOULD BE EXPECTED IF THE CUTTING HEAD BECAME STUCK DURING THE REAMING PROCESS; THE TIP OF THE FLEXIBLE SHAFT WOULD TWIST. IT IS UNKNOWN FROM THE COMPLAINT DESCRIPTION IF PROPER TECHNIQUE WAS FOLLOWED, I.E. 8.5MM HEAD THROUGH 13MM HEAD WITH 0.5MM INCREMENTS. THE SYSTEM¿S MEDULLARY REAMER HEADS RANGE IN SIZES FROM 8.5-19MM IN 0.5MM INCREMENTS. THE 8.5MM HEAD IS FRONT CUTTING AND THE REMAINDERS ARE SIDE CUTTING. THE FLEXIBLE REAMERS FOR IM NAILS TECHNIQUE STATES ¿TO REDUCE THE LIKELIHOOD OF THE REAMER HEAD JAMMING INTRAOPERATIVELY, DO NOT SKIP REAMER HEAD SIZES¿. IN THIS INSTANCE IT IS LIKELY THAT THE 13MM REAMER HEAD GOT STUCK AFTER PARTIALLY COMPLETING THE REAMING WHICH CAUSED THE DISTAL END OF THE INSTRUMENT TO EXPERIENCE A HEAVY TORQUE LOAD LEADING TO THE FAILURE. A DEFINITIVE ROOT CAUSE WAS UNABLE TO BE DETERMINED HOWEVER THE FLEXIBLE SHAFT FAILURE IS CONSISTENT WITH A STUCK REAMER HEAD WHICH COULD BE THE RESULT OF HARD BONE OR SKIPPING HEAD SIZES DURING REAMING. THIS LIKELY CAUSED THE REAMER HEAD TO BECOME LODGED IN THE IM CANAL WHICH ALLOWED THE SHAFT TO EXPERIENCE AN EXTREME AMOUNT OF TORQUE ON THE DISTAL TIP. AS PREVIOUSLY REPORTED, THE 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. A DEFINITIVE ROOT CAUSE WAS UNABLE TO BE DETERMINED; HOWEVER, BASED ON THE COMPLAINT DESCRIPTION, THE FAILURE IS THE RESULT OF EXCESSIVE LOAD APPLIED TO THE DEVICE. 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: PATIENT INFORMATION WAS NOT PROVIDED BY REPORTER. DEVICE IS AN INSTRUMENT AND IS NOT IMPLANTED/EXPLANTED. (B)(4) -FOR ADDITIONAL INTERVENTION NEEDED TO REMOVE REAMER SHAFT AND UNKNOWN SURGICAL DELAY (POSSIBLE EXTENDED SEDATION). A DEVICE HISTORY RECORD REVIEW WAS PERFORMED FOR THE SUBJECT DEVICE LOT. THE REVIEW SHOWED THAT THERE WERE NO ISSUES DURING THE MANUFACTURE OF THE PRODUCT THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. NO NON-CONFORMANCES WERE GENERATED DURING THE PRODUCTION OF THE SUBJECT DEVICE. THE SUBJECT DEVICE HAS BEEN RECEIVED AND IS CURRENTLY IN THE EVALUATION PROCESS. 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 MALE PATIENT PRESENTED WITH AN INFECTION RELATED TO HIS UNKNOWN KNEE REPLACEMENT PROSTHESIS. IT IS NOT KNOWN IF THE KNEE PROSTHESIS IS A SYNTHES PRODUCT. ADDITIONAL PATIENT HISTORY WAS NOT MADE AVAILABLE. THE SURGEON SURGICALLY REMOVED THE PROSTHETIC KNEE REPLACEMENT TO PREPARE THE JOINT FOR FUSION. WHILE REAMING THE PROXIMAL TIBIA WITH THE FLEXIBLE REAMING SHAFT AND 13MM REAMING BIT UNDER POWER, THE REAMING BIT (REAMER HEAD) BROKE APART IN THE MEDULLARY CANAL OF THE TIBIA. THE REAMING SHAFT BECAME DEFORMED WHERE THE BIT ATTACHED. THE REAMING SHAFT WAS REMOVED. MOST OF THE FRAGMENTS OF THE BROKEN REAMING BIT WERE REMOVED, BUT NOT ALL WERE ABLE TO BE RETRIEVED. THE ATTEMPT TO RETRIEVE THE BROKEN FRAGMENTS CAUSED A SURGICAL DELAY BUT THE ACTUAL DURATION OF THE DELAY IS UNKNOWN. THE PROCEDURE WAS SUCCESSFULLY COMPLETED AND PATIENT WAS NOT HARMED. THIS COMPLAINT ADDRESSES THE FLEXIBLE REAMER SHAFT AND THE REAMER HEAD. THIS REPORT IS 1 OF 2 FOR (B)(4)

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    343825 5.0MM FLEXIBLE SHAFT REAMER HTO SYNTHES BETTLACH 7771080

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention