BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    12.0MM/8.0MM PROTECTION SLEEVE188MM

    MDR report key: 6485831 · Received April 12, 2017

    Report

    Report Number
    3003875359-2017-10181
    Event Type
    Malfunction
    Date Received
    April 12, 2017
    Date of Event
    March 19, 2017
    Report Date
    March 20, 2017
    Manufacturer
    SYNTHES HAGENDORF
    Product Code
    LXH
    UDI-DI
    10886982067371
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. THIS COMPLAINT WAS NOT ABLE TO BE CONFIRMED AT CQ AS NO DEVICES WERE RETURNED FOR INVESTIGATION, AND NO PHOTOS OR X-RAYS WERE PROVIDED SHOWING THE REPORTED MISALIGNMENT CONDITION. THIS COMPLAINT WAS NOT ABLE TO BE REPLICATED AT CQ AS NO DEVICES WERE RETURNED FOR INVESTIGATION. NO NEW MALFUNCTIONS WERE IDENTIFIED AS A RESULT OF THE INVESTIGATION. PART#03.010.063 LOT#3431392, 12.0MM/8.0MM PROTECTION SLEEVE188MM. A VISUAL INSPECTION COULD NOT BE PERFORMED AT CQ BECAUSE THE DEVICE WAS NOT RETURNED. A FUNCTIONAL TEST COULD NOT BE PERFORMED AT CQ BECAUSE THE DEVICE WAS NOT RETURNED. A DIMENSIONAL INSPECTION COULD NOT BE PERFORMED AT CQ BECAUSE THE DEVICE WAS NOT RETURNED. DRAWINGS WERE REVIEWED DURING THIS INVESTIGATION. NO PRODUCT DESIGN ISSUES OR DISCREPANCIES WERE OBSERVED. A DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED. PER THE COMPLAINT DESCRIPTION "IT APPEARS THAT THE EQUIPMENTS WERE MISUSED BY THE SURGEON IN THE CASE. THE HOSPITAL DOES NOT THINK THAT THERE WERE ANY ISSUES WITH THE DEVICES. THE DEVICES WILL NOT BE RETURNED FOR EVALUATION." COMPLAINT IS UNCONFIRMED AND PER THE COMPLAINT DESCRIPTION "IT APPEARS THAT THE EQUIPMENTS WERE MISUSED BY THE SURGEON IN THE CASE. THE HOSPITAL DOES NOT THINK THAT THERE WERE ANY ISSUES WITH THE DEVICES. THE DEVICES WILL NOT BE RETURNED FOR EVALUATION." 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 USED FOR TREATMENT, NOT DIAGNOSIS. ADDITIONAL NARRATIVE: PATIENT INFORMATION NOT AVAILABLE FOR REPORTING. DEVICE IS AN INSTRUMENT AND IS NOT IMPLANTED/EXPLANTED. DEVICE IS NOT EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION. CONCOMITANT DEVICES REPORTED: THERAPY DATES: DRIVING CAP WITH HANDLE ADAPTER (PART# 03.010.047, LOT# 3432404, QTY 1). CANNULATED CONNECTING SCREW FOR STANDARD INSERTION HANDLE (PART# 03.010.044, LOT# U216997/U182107, QTY 1). CANNULATED CONNECTING SCREW FOR STANDARD INSERTION HANDLE (PART# 03.010.044, LOT# U182107, QTY 1). NAIL (PART# UNKNOWN, LOT# UNKNOWN, QTY 1). INSERTION HANDLE FOR ADOLESCENT LATERAL ENTRY FEMORAL NAIL-EX (PART# 03.010.226, LOT# 3036801, QTY 1). AIMING ARM FOR ADOLESCENT LATERAL ENTRY FEMORAL NAIL-EX (PART# 03.010.227, LOT# 3319931, QTY 1). DRILL (PART# UNKNOWN, LOT# UNKNOWN, QTY 1). (B)(6). DEVICE HISTORY RECORDS REVIEW WAS CONDUCTED. THE REPORT INDICATES THAT THE: MANUFACTURING LOCATION: (B)(4), MANUFACTURING DATE: 28 APRIL 2010. NO NCR'S WERE GENERATED DURING PRODUCTION THAT WOULD CONTRIBUTE TO THE COMPLAINT CONDITION. THE REVIEW OF THE DEVICE HISTORY RECORD SHOWS THAT THERE WERE NO ISSUES DURING THE MANUFACTURE OF THE PRODUCT THAT WOULD CONTRIBUTE TO THE COMPLAINT CONDITION. 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

    (B)(6) REPORTED THE FOLLOWING EVENT: IT WAS REPORTED THAT THE DRILL SLEEVE, DRILL GUIDE, AND DRILL BIT DID NOT LINE UP WITH THE HOLES IN THE NAIL DURING A FRACTURE FEMUR PROCEDURE ON (B)(6) 2017. THE CONSTRUCT WHICH CONSISTED OF THE AIMING ARM, INSERTION HANDLE, CONNECTING SCREW, DRILL SLEEVE, DRILL GUIDE, AND DRILL BIT WAS CHECKED WITH THE NAIL PRIOR TO DRILLING AND EVERYTHING LINED UP. THE NAIL WAS INSERTED. DURING DRILLING, IT WAS FOUND THAT THE THREE DEVICES (DRILL SLEEVE, DRILL GUIDE, AND DRILL BIT) DID NOT ALIGN PROPERLY WITH THE HOLES IN THE NAIL. AFTER SEVERAL FAILED ATTEMPTS, SURGEON HAD TO DRILL FREEHANDEDLY. THE SAME NAIL WAS IMPLANTED. THERE WAS A TWENTY MINUTES SURGICAL DELAY DUE TO THE SEVERAL ATTEMPTS. NO OTHER MEDICAL INTERVENTION WAS REQUIRED. PATIENT OUTCOME/STATUS WAS REPORTED AS STABLE. NO PATIENT HARM REPORTED. THE HOSPITAL BELIEVED THAT THE DRILL SLEEVE WAS NOT FAR IN ENOUGH CAUSING THE DRILL BIT TO BE PUSHED DOWN BY THE SOFT TISSUE. IT APPEARS THAT THE EQUIPMENTS WERE MISUSED BY THE SURGEON IN THE CASE. THE HOSPITAL DOES NOT THINK THAT THERE WERE ANY ISSUES WITH THE DEVICES. THE DEVICES WILL NOT BE RETURNED FOR EVALUATION. SINCE THE DRILL SLEEVE, DRILL GUIDE, AND DRILL BIT DID NOT LINE UP WITH THE HOLES IN THE NAIL, SURGEON EXCHANGED THE CONNECTING SCREW. HOWEVER, THERE WAS STILL A MISALIGNMENT BETWEEN THE DRILL SLEEVE, DRILL GUIDE, AND DRILL BIT. NO ISSUES WITH THE CONNECTION OR WITH BOTH CONNECTING SCREWS. TWO DRILL BITS WERE USED USING SURGERY AND THEY BOTH DID NOT LINE UP. PROCEDURE WAS SUCCESSFULLY COMPLETED. THIS COMPLAINT INVOLVES FOUR DEVICES. CONCOMITANT DEVICES REPORTED: DRIVING CAP WITH HANDLE ADAPTER (PART# 03.010.047, LOT# 3432404, QTY 1); CANNULATED CONNECTING SCREW FOR STANDARD INSERTION HANDLE (PART# 03.010.044, LOT # U216997/U182107, QTY 1) ;CANNULATED CONNECTING SCREW FOR STANDARD INSERTION HANDLE (PART# 03.010.044, LOT# U182107, QTY 1); NAIL (PART# UNKNOWN, LOT# UNKNOWN, QTY 1) INSERTION HANDLE FOR ADOLESCENT LATERAL ENTRY FEMORAL NAIL-EX (PART# 03.010.226, LOT# 3036801, QTY 1) AIMING ARM FOR ADOLESCENT LATERAL ENTRY FEMORAL NAIL-EX (PART# 03.010.227, LOT# 3319931, QTY 1) DRILL (PART# UNKNOWN, LOT# UNKNOWN, QTY 1). THIS REPORT IS 1 OF 4 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    266582 12.0MM/8.0MM PROTECTION SLEEVE188MM MISC ORTHO SURGICAL INSTRUMENT LXH SYNTHES HAGENDORF 3431392 10886982067371

    Patients

    Seq Age Sex Outcome Treatment
    1