BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DRIVING CAP/THREADED

    MDR report key: 6103523 · Received November 15, 2016

    Report

    Report Number
    2520274-2016-15396
    Event Type
    Malfunction
    Date Received
    November 15, 2016
    Date of Event
    October 24, 2016
    Report Date
    October 24, 2016
    Manufacturer
    SYNTHES USA
    Product Code
    LXH
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DEVICE IS AN INSTRUMENT AND IS NOT IMPLANTED / EXPLANTED. THE DEVICE WAS RECEIVED AND THE PRODUCT EVALUATION IS IN PROGRESS. NO CONCLUSION CAN BE DRAWN. DEVICE HISTORY RECORDS REVIEW COULD NOT BE COMPLETED WITHOUT LOT NUMBER. DEVICE 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

    AN INVESTIGATION SUMMARY WAS PERFORMED. THE INVESTIGATION OF THE COMPLAINT ARTICLES HAS SHOWN THAT: ONE DRIVING CAP (PART # 03.010.523, LOT # UNKNOWN) WAS RETURNED FOR INVESTIGATION. THE DRIVING CAP SHOWS REGULAR USE, WITH HAMMER MARKS AND GOUGES ON THE HEAD OF THE DEVICE CONSISTENT WITH HIGH IMPACT FORCE. THE DISTAL THREADED TIP OF THE OF THE DRIVING CAP IS BROKEN OFF AND WAS RETURNED. ALTHOUGH THE EXACT CAUSE FOR THE COMPLAINT CONDITION COULD NOT BE DETERMINED, THE DAMAGE APPEARS TO BE THE RESULT OF HAMMERING ON THE DEVICE BEFORE IT WAS FULLY SEATED AGAINST THE INSERTION HANDLE. DURING THE INVESTIGATION NO PRODUCT DESIGN ISSUES OR DISCREPANCIES WERE OBSERVED THAT MAY HAVE CONTRIBUTED TO THE COMPLAINT CONDITION. A VISUAL INSPECTION, COMPLAINT HISTORY REVIEW, DRAWING REVIEW, AND RISK ASSESSMENT REVIEW WERE PERFORMED AS PART OF THIS INVESTIGATION. NO PRODUCT DESIGN ISSUES OR DISCREPANCIES WERE OBSERVED. THIS COMPLAINT CONDITION IS CONFIRMED. DEVICE 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

    IT WAS REPORTED THAT ON (B)(6) 2016, A PATIENT UNDERWENT SURGERY FOR A MID-SHAFT DISTAL FEMUR FRACTURE OF THE RIGHT SIDE. WHILE THE SURGEON WAS INSERTING A RETROGRADE FEMORAL NAIL (13MM X 360 LENGTH), THE INSERTION HANDLE HIT THE DRIVING CAP AND THE TIP OF THE DRIVING CAP BROKE OFF INSIDE THE INSERTION HANDLE. THE SURGEON FINISHED THE PROCEDURE BY PLACING THE DRIVING CAP IN THE SAME HOLE OF THE INSERTION HANDLE WITH HIS HANDS AND WAS ABLE TO FULLY INSERT THE NAIL. THERE WAS NO SURGICAL TIME DELAY REPORTED. THERE WERE PLANNED X-RAYS TAKEN DURING THE PROCEDURE BUT ARE NOT AVAILABLE. THE SURGERY WAS SUCCESSFULLY COMPLETED. THE PATIENT OUTCOME WAS REPORTED AS GOOD. CONCOMITANT DEVICES REPORTED: RETROGRADE FEMORAL NAIL (13MM X 360 LENGTH) - PART# 04.013.752S, LOT# H132245, QUANTITY# 1. AIMING ARM - PART# UNKNOWN, LOT# UNKNOWN, QUANTITY# 1. RADIOLUCENT INSERTION HANDLE FOR EXPERT NAILS/100MM - PART# 03.010.486, LOT# 9102626, QUANTITY# 1. THIS REPORT IS FOR ONE (1) DRIVING CAP. THIS IS REPORT 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    752357 DRIVING CAP/THREADED MISC ORTHO SURGICAL INSTR LXH SYNTHES USA

    Patients

    Seq Age Sex Outcome Treatment
    1 21 YR ONE (1) UNKNOWN AIMING ARM| PART# 03.010.486, LOT# 9102626, QUANTITY# 1| PART# 04.013.752S, LOT# H132245, QUANTITY# 1