BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STANDARD INSERTION HANDLE

    MDR report key: 6714521 · Received July 14, 2017

    Report

    Report Number
    3003875359-2017-10341
    Event Type
    Injury
    Date Received
    July 14, 2017
    Date of Event
    June 16, 2017
    Report Date
    June 16, 2017
    Manufacturer
    SYNTHES HAGENDORF
    Product Code
    LXH
    UDI-DI
    10886982067173
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL NARRATIVE CUSTOMER QUALITY INVESTIGATION OF RETURNED DEVICES A VISUAL INSPECTION , DHR REVIEW, AND DRAWING REVIEW WERE PERFORMED AS PART OF THIS INVESTIGATION. WHETHER THIS COMPLAINT CAN BE REPLICATED AT CUSTOMER QUALITY (CQ) IS NOT APPLICABLE FOR THIS COMPLAINT CONDITION AS THE RETURNED DEVICES ARE ALREADY MISSING COMPONENTS. THE 03.120.011, LOT NUMBER 1810703, PERIARTICULAR AIMING ARM FOR 4.5MM LCP CURVD CONDYLAR PL-LT WAS RETURNED WITH A MISSING COUPLING BOLT. THIS COMPLAINT IS CONFIRMED. THE BOLT WAS NOT RETURNED WITH THE INSTRUMENT. THE COUPLING BOLT SHEARED OFF FROM THE 8MM PIN. ALTHOUGH A DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED, IT IS LIKELY THAT THIS COMPLAINT CONDITION WAS DUE TO CONSISTENT/EXCESSIVE FORCE BEING APPLIED TO THE BOLT OVER THE PART¿S LIFETIME (9+ YEARS) LEADING TO THE BREAKAGE. THE 03.010.045, LOT NUMBER 1627067, STANDARD INSERTION HANDLE WAS RETURNED WITH THE TANG (ALIGNMENT TAB) BROKEN OFF. THIS COMPLAINT IS CONFIRMED. ALTHOUGH A DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED, IT IS LIKELY THAT THIS COMPLAINT CONDITION WAS DUE TO EXCESSIVE BENDING FORCES WHEN THE SURGEON WAS "ROTATING THE INSERTION HANDLE" CAUSING MATERIAL FATIGUE AND BREAKAGE OF THE TANG. THIS COMPLAINT CONDITION IS CONSISTENT WITH CONSTANT USAGE OVER THE PART¿S LIFETIME (10+ YEARS). DRAWING MFG TO CURRENT WERE REVIEWED AND DETERMINED TO BE SUITABLE FOR THE INTENDED DESIGN, APPLICATION AND DIMENSIONAL CONFORMITY WHEN USED AS RECOMMENDED. A DESIGN CHANGE TO IMPROVE THE STRENGTH OF TANG WAS IMPLEMENTED. THIS DESIGN CHANGE IS RELATED TO THIS COMPLAINT CONDITION AND CAN POSSIBLY HELP PREVENT FUTURE SIMILAR COMPLAINTS. THE DESIGN AND CLINICAL RISK MANAGEMENT (DCRM) DOCUMENT WAS REVIEWED AND FOUND TO ADEQUATELY ADDRESS THE HARM OF 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

    PATIENT AGE/DATE OF BIRTH AND WEIGHT WERE NOT PROVIDED FOR REPORTING. DEVICE IS AN INSTRUMENT AND IS NOT IMPLANTED / EXPLANTED. DEVICE HISTORY RECORDS REVIEW WAS COMPLETED FOR PART# 03.010.045, LOT# 1627067. MANUFACTURING LOCATION: (B)(4), MANUFACTURING DATE: MAR 05, 2007. NO NON CONFORMANCE REPORTS WERE GENERATED DURING PRODUCTION. REVIEW OF THE DEVICE HISTORY RECORDS SHOWED THAT THERE WERE NO ISSUES DURING THE MANUFACTURE OF THE PRODUCT THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. THE DEVICE WAS RECEIVED AND THE PRODUCT EVALUATION IS IN PROGRESS. NO CONCLUSION CAN BE DRAWN. 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

    HOLD FOR JEWEL 11/15/17

    Description of Event or Problem · 1

    IT WAS REPORT THAT THE PATIENT HAD ORIGINAL SURGERY ON (B)(6) 2017 FOR TREATMENT OF A POLY-TRAUMA TO THE RIGHT FEMUR BONE DUE TO A (MVA) MOTOR VEHICLE ACCIDENT. PATIENT WAS IMPLANTED WITH A ONE (1) 12 MM LATERAL ENTRY FEMORAL RECONSTRUCTION EXPERT (EX) NAIL, TWO (2) 6.5 MM RECONSTRUCTION SCREWS AND ONE (1) 5.0 MM LOCKING SCREW TO TREAT THE PATIENT¿S BROKEN MEDSHAFT FRACTURE. PATIENT WAS ALSO IMPLANTED WITH ONE (1) 4.5 MM LOCKING COMPRESSION PLATE (LCP®) CURVED CONDYLAR PLATE, WITH A UNKNOWN QUANTITY OF VARIOUS LENGTHS OF CANNULATED LOCKING SCREWS TO ADDRESS THE PATIENTS DISTAL FEMUR FRACTURE. DURING THE PROCEDURE, WHILE THE SURGEON WAS IMPLANTING THE LATERAL ENTRY FEMORAL NAIL, WHILE HE WAS DRILLING THROUGH THE NAIL AND ROTATING THE INSERTION HANDLE, THE ALIGNMENT METAL TAB TO THE INSERTION HANDLE BROKE OFF. ADDITIONAL IMAGES WERE TAKEN TO LOCATE THIS 2 MM BY 3 MM IN SIZE FRAGMENT, BUT IT COULD NOT BE LOCATED. SURGEONS CHOSE ANOTHER INSERTION HANDLE THAT WAS AVAILABLE IN THE OPERATING ROOM TO COMPLETE THE SURGERY. DUE TO THIS EVENT AN ADDITIONAL 15-MINUTE DELAY WAS ADDED TO OPERATING ROOM TIME. SURGEON COMPLETED THE NAIL INSERTION AND CONTINUED WITH THE DISTAL COMPRESSION PLATE AND SCREWS PORTION OF THE PROCEDURE. DURING THE PLATE AND SCREW INSERTION SEGMENT OF THE PROCEDURE, AS THE SURGEON WAS TIGHTENING DOWN WITH THE AIMING ARM INSTRUMENT TO CONNECT THE CONDYLAR PLATE, THE BOLT THAT IS A COMPONENT OF THE AIMING ARM INSTRUMENT SHEARED OFF AND LANDED ON THE OPERATING ROOM FLOOR. THIS BOLT IS 20 MM IN SIZE AND WAS EASILY RETRIEVED. SURGEON DISCONNECTED THE AIMING ARM INSTRUMENT AND CONTINUED THE PROCEDURE BY USING A STANDARD DRILL GUIDE THAT WAS AVAILABLE IN THE OPERATING ROOM. DUE TO THIS EVENT AN ADDITIONAL 10-MINUTE DELAY WAS ADDED TO OPERATING ROOM TIME. SURGERY WAS COMPLETED SUCCESSFULLY WITH A 25-MINUTE TOTAL TIME DELAY DUE TO BOTH EVENTS. THE PATIENT WAS REPORTED IN STABLE CONDITION. CONCOMITANT DEVICES REPORTED: 12 MM TI LATERAL ENTRY FEMORAL RECONSTRUCTION NAIL EX400MM/RIGHT STERILE (PART# 04.003.560S, QUANTITY 1). 6.5 MM TI RECONSTRUCTION SCREW WITH T25 STARDRIVE 105 MM-STERILE (PART # 04.003.031S, QUANTITY 1). 6.5 MM TI RECONSTRUCTION SCREW WITH T25 STARDRIVE 100 MM-STERILE (PART# 04.003.030S, QUANTITY 1). 5.0 MM TI LOCKING SCREW W/T25 STARDRIVE 44 MM FOR NAILS (PART# 04.005.534S, QUANTITY 1) 4.5 MM LCP® CURVED CONDYLAR PLATE 16H/350 MM LEFT STERILE (PART# 02.001.306S, QUANTITY 1) 7.3 MM CANNULATED LOCKING SCREW (VARIOUS SCREW LENGTHS). THIS REPORT IS FOR ONE (1) STANDARD INSERTION HANDLE. THIS IS REPORT 2 OF 2 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    496347 STANDARD INSERTION HANDLE MISC ORTHO SURGICAL INSTR LXH SYNTHES HAGENDORF 1627067 10886982067173

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention PART # 04.003.031S, LOT# UNKNOWN, QUANTITY 1| PART# 02.001.306S, LOT# UNKNOWN, QUANTITY 1| PART# 04.003.030S, LOT# UNKNOWN, QUANTITY 1| PART# 04.003.560S, LOT# UNKNOWN, QUANTITY 1| PART# 04.005.534S, LOT# UNKNOWN, QUANTITY 1| UNKNOWN QUANTITY OF UNKNOWN 7.3MM LOCKING SCREWS