BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LCP® DHHS(TM) INSERTER GUIDE

    MDR report key: 3093595 · Received May 6, 2013

    Report

    Report Number
    2530088-2013-00776
    Event Type
    Injury
    Date Received
    May 6, 2013
    Date of Event
    April 9, 2013
    Report Date
    April 9, 2013
    Manufacturer
    SYNTHES BRANDYWINE
    Product Code
    FZX
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE IS USED FOR TREATMENT, NOT DIAGNOSIS INVESTIGATION IS ON-GOING. SUBJECT DEVICE HAS BEEN RECEIVED AND IS CURRENTLY IN THE EVALUATION PROCESS. NO CONCLUSION CAN BE DRAWN. REVIEW OF MANUFACTURING RECORDS HAS BEEN REQUESTED.

    Additional Manufacturer Narrative · 1

    ADDITIONAL NARRATIVE: DEVICE IS LABELED FOR MULTIPLE DEVICE. A PRODUCT DEVELOPMENT EVENT EVALUATION WAS CONDUCTED. THE REPORT RECEIVED INDICATES THE RISK ANALYSIS INCLUDES THE HAZARD OF GENERAL INSTRUMENT BREAKAGE AND OF COUPLING SCREW BREAKAGE. THE RISK ANALYSIS WILL REQUIRE SUBSEQUENT UPDATING TO ADDRESS THE INCREASE IN THE RATE OF OCCURRENCE. THE HELIX BLADE IS MADE FROM IMPLANT GRADE 316L, A COMMONLY USED MATERIAL FOR IMPLANTS. THE INSTRUMENTS ARE MADE FROM COMMON MATERIALS WITH APPROPRIATE TREATMENTS. THE DHHS WAS RELEASED IN 2005 WITH OVER SEVEN YEARS OF SUCCESSFUL FIELD SERVICE. IN ADDITION, THE INSERTER GUIDE WAS MANUFACTURED IN 2006 INDICATING MANY YEARS OF UNEVENTFUL, SUCCESSFUL SERVICE. THE HELIX BLADE IS SCRATCHED AND GOUGED, INDICATING POTENTIAL MISUSE OR IMPROPER TIGHTENING OF THE COUPLING SCREW. THE FACT THAT TWO INSTRUMENTS BROKE DURING THE SAME SURGERY ALSO LEADS TO QUESTIONS REGARDING THE SURGICAL TECHNIQUE. HOWEVER, THE INCREASED RATE OF OCCURRENCE IS CAUSE FOR CONCERN. WITH ALL OF THESE COMPETING FACTORS, IT IS DIFFICULT TO DETERMINE WHETHER OR NOT THE DESIGN PLAYED A ROLE IN THE DEVICE FAILURE.

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS.(B)(4)

    Additional Manufacturer Narrative · 1

    ADDITIONAL NARRATIVE: DEVICE IS USED FOR TREATMENT, NOT DIAGNOSIS A REVIEW OF THE DHR INDICATES THERE WAS (B)(4) FOR: L2 OVERSIZE ON 1 PART, AND FOUR VISUAL NONCONFORMANCES - TOTAL (B)(4) PARTS WITH VISUAL NONCONFORMANCES. THE ONE PART FOR L2 WAS SCRAPPED. TWO OF THE PARTS WITH VISUAL NONCONFORMANCES WERE SCRAPPED. FIVE PARTS WITH VISUAL NONCONFORMANCES WERE DISPOSITIONED AS CONFORMS WITH RATIONALE THAT THEY ARE ACCEPTABLE AND A VISUAL STANDARD WILL BE CREATED. FOUR PARTS WITH VISUAL NONCONFORMANCE OF NICKS WERE NOT DISPOSITIONED. IT CANNOT BE DETERMINED IF THE COMPLAINT PART HAS UNACCEPTABLE NICKS UNTIL IT IS RETURNED. THERE WERE NO ANOMALIES WHICH COULD HAVE CAUSED OR CONTRIBUTED TO THIS COMPLAINT. ALL OTHER RECORDS INDICATE THE PRODUCT WAS MANUFACTURED TO SPECIFICATIONS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A SURGERY FOR A TROCHANTERIC FEMUR FRACTURE, IN THE MIDDLE OF INSERTION OF THE HELICAL BLADE WITH THE LCP COUPLING SCREW THE SCREW BROKE INSIDE OF THE HELICAL BLADE. THE ORIGINAL HELICAL BLADE WAS DISCARDED AND ANOTHER CHOSEN FROM THE SET. THE SECOND HELICAL BLADE WAS IMPLANTED WITHOUT USE OF THE COUPLING SCREW. AT THE BACK TABLE, WHILE THE TECH WAS ASSEMBLING THE HELIX BLADE INSERTER, THE BLADE INSERTER BROKE IN HALF. WITH SOME MANIPULATION OF THE INSERTER THE SURGEON WAS ABLE TO CONTINUE USING THE SYSTEM TO FINISH THE IMPLANTING THE BLADE. THIS REPORT IS #2 OF 3 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    197080 LCP® DHHS(TM) INSERTER GUIDE FZX SYNTHES BRANDYWINE 4997221

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR Required Intervention