BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PERIARTICULAR AIMING ARM FOR 4.5MM LCP PROX TIBIA PL-RT

    MDR report key: 4536530 · Received February 23, 2015

    Report

    Report Number
    3003875359-2015-10114
    Event Type
    Malfunction
    Date Received
    February 23, 2015
    Report Date
    February 9, 2015
    Manufacturer
    SYNTHES HAGENDORF
    Product Code
    FZX
    PMA / PMN Number
    PEXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE IS AN INSTRUMENT AND IS NOT IMPLANTED/EXPLANTED. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. A DEVICE HISTORY REVIEW WAS CONDUCTED. THE REPORT INDICATES THAT NO NCRS WERE GENERATED DURING PRODUCTION. REVIEW OF THE DEVICE HISTORY RECORD(S) SHOWED THAT THERE WERE NO ISSUES DURING THE MANUFACTURE OF THE PRODUCT THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. 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

    THIS DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. THE PRODUCT INVESTIGATION SHOWS, THE 03.120.001 LOT# 1802318 PERIARTICULAR AIMING ARM, RIGHT WAS RECEIVED INTACT. THE DEVICE IS APPROXIMATELY 7 YEARS OLD AND IS IN GOOD CONDITION ASIDE FROM SOME MODERATE SIGNS OF WEAR ON THE CONNECTING SCREW KNOB. THE AIMING HOLES AND INSERTION HANDLE CONNECTION POINT ARE CLEAN WITH NO BURRS OR SIGNS OF DAMAGE VISIBLE. THE PERIARTICULAR AIMING ARM IS FOR PLACEMENT OF SCREWS IN 4.5MM LCP PROXIMAL TIBIA PLATES. THE OLD (LOT #1797331) AND NEW (LOT # 3148907) VERSIONS OF THE PERIARTICULAR INSERTION HANDLE, LEFT (03.120.005) WERE TESTED WITH THE PERIARTICULAR AIMING ARM, LEFT (03.120.004). THE OLDER VERSION OF THE INSERTION HANDLE (LOT #1797331) FIT SECURELY WITH THE CONNECTION BOLT OF THE AIMING ARM AND FUNCTIONED APPROPRIATELY. THE NEWER VERSION OF THE INSERTION HANDLE (LOT # 3148907) INTERFERES WITH ONE OF THE MATING EDGES OF THE AIMING ARM AND AS A RESULT CANNOT BE SECURED TO THE AIMING ARM WITH THE CONNECTION BOLT. THE OLDER (LOT #1829294) AND NEWER (LOT #3156787) VERSIONS OF THE PERIARTICULAR INSERTION HANDLE, RIGHT (03.120.002) WERE TESTED WITH THE PERIARTICULAR AIMING ARM, RIGHT (03.120.001). THE OLDER VERSION OF THE INSERTION HANDLE MATED PROPERLY TO THE AIMING ARM, BUT THE NEWER VERSION INTERFERES WITH ONE OF THE MATING EDGES OF THE AIMING ARM AND CANNOT BE SECURED TO THE AIMING ARM USING THE CONNECTION BOLT. THE RADIUS WAS CHANGED ON THE MATING EDGE OF THE INSERTION HANDLE AND AIMING ARM FROM 10MM IN THE OLD DESIGN TO 8MM IN THE FULLY RELEASED VERSION. THIS RADIUS DIFFERENCE WAS CONFIRMED WITH THE RECEIVED PARTS USING AN OPTICAL COMPARATOR. THIS COMPLAINT IS CONFIRMED AND DESIGN RELATED. 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: DATE RETURNED TO MANUFACTURER. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS THE PRODUCT IS ENTERING THE COMPLAINT SYSTEM. A REVIEW OF THE DEVICE HISTORY RECORDS WAS PERFORMED AND NO COMPLAINT RELATED ISSUES WERE FOUND. 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 THERE IS A COMPLAINT-UNSPECIFIED) REGARDING 4 PARTS. NO PATIENT INVOLVEMENT. THERE ARE FOUR PARTS (PART #03.120.002-INSERTION HANDLE, #03.120.005-INSERTION HANDLE, #03.120.004-AIMING ARM, #03.120.001-AIMING ARM) THAT ARE 8 YEARS OLD AND TWO NEW PARTS (PART# 03.120.002, PART# 03.120.005) THAT WAS RECENTLY PURCHASED DUE TO PART AGE. THE NEW PARTS WERE RECEIVED 2 DAYS AGO. IT WAS REPORTED THAT THE NEW PARTS LOOKED DIFFERENT THAN THE OLD PARTS AND DID NOT FIT WITH TWO AIMING ARMS. PRODUCT DEVELOPMENT ENGINEERS WAS CONTACTED TO DETERMINE IF THE PART DESIGN HAD CHANGED, AND IT WAS CONFIRMED THAT IT WASN¿T. THERE WAS NO PATIENT INVOLVEMENT, AND ALL PARTS WILL BE RETURNED FOR EVALUATION. THIS IS REPORT 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    126723 PERIARTICULAR AIMING ARM FOR 4.5MM LCP PROX TIBIA PL-RT GUIDE FZX SYNTHES HAGENDORF 1802318

    Patients

    Seq Age Sex Outcome Treatment
    1