BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    14.0MM CANNULATED AWL

    MDR report key: 4110598 · Received September 23, 2014

    Report

    Report Number
    3003875359-2014-10277
    Event Type
    Malfunction
    Date Received
    September 23, 2014
    Date of Event
    August 6, 2014
    Report Date
    August 6, 2014
    Manufacturer
    SYNTHES HAGENDORF
    Product Code
    HWJ
    PMA / PMN Number
    PEXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE IS AN INSTRUMENT AND IS NOT IMPLANTED/EXPLANTED. A DEVICE HISTORY REVIEW WAS CONDUCTED. THE REPORT INDICATES THAT THERE ARE 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. SUBJECT DEVICE HAS BEEN RECEIVED AND IS CURRENTLY IN THE EVALUATION PROCESS. 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

    ADDITIONAL NARRATIVE: A PD EVALUATION WAS CONDUCTED. THE REPORT INDICATES THAT THE RETURNED AWL IS A DEVICE RECOMMENDED AS AN ALTERNATIVE TECHNIQUE FOR INITIAL OPENING OF THE MEDULLARY CANAL. GAGING BY THE PATIENTS AGE AND WEIGHT, IT IS LIKELY THAT AN ALFN PROCEDURE WAS PERFORMED. THE ADOLESCENT LATERAL FEMORAL NAIL (ALFN-EX) IS INDICATED FOR USE IN ADOLESCENT AND SMALL-STATURE ADULT PATIENTS TO STABILIZE: FRACTURES OF THE FEMORAL SHAFT, SUBTROCHANTERIC FRACTURES, IPSILATERAL NECK/SHAFT FRACTURES, IMPENDING PATHOLOGIC FRACTURES, NONUNIONS AND MALUNIONS. THE DEVICE IS ALSO RECOMMENDED FOR USE WITH RAFN, LFRN &LFN. THE RETURNED DEVICE SHOWS EVIDENCE OF SIGNIFICANT HAMMER MARKS TO THE MOST PROXIMAL LATERAL SURFACE OF THE HANDLE. HAMMERING OF THIS DEVICE IF PERFORMED IN THE EVIDENT DIAGONAL DIRECTION, SUCH ANGLED FORCE WOULD BE TRANSFERRED TO CANNULATED TIP CAUSING IT TO BREAK OFF. THE RETURNED DEVICE WAS MANUFACTURED ON 6/4/2007 AND IS APPROXIMATELY 7 YEARS OLD. THIS COMPLAINT IS CONFIRMED; HOWEVER WE ARE UNABLE TO DEFINITIVELY DETERMINE THE CAUSE OF THE COMPLAINT. INVESTIGATION SUMMARY: THIS MAY HAVE RESULTED IN THIS CONFIRMED COMPLAINT. 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

    AN EVALUATION WAS PERFORMED ON THE RETURNED DEVICE. AS PER RECEIVED CONDITION OF DEVICE; THE AWL WAS RECEIVED WITH A 15MM PIECE OF THE DISTAL TIP BROKEN OFF AND MISSING. PROXIMAL HANDLE CURVE SECTION CONTAINS SIGNIFICANT HAMMER MARKS ON THE MOST OUTBOARD SURFACE. THE RETURNED AWL IS A DEVICE RECOMMENDED TECHNIQUE GUIDE AS AN ALTERNATIVE TECHNIQUE FOR INITIAL OPENING OF THE MEDULLARY CANAL. THE ADOLESCENT LATERAL FEMORAL NAIL (ALFN)EX IS INDICATED FOR USE IN ADOLESCENT AND SMALL-STATURE ADULT PATIENTS TO STABILIZE: FRACTURES OF THE FEMORAL SHAFT, SUBTROCHANTERIC FRACTURES, IPSILATERAL NECK/SHAFT FRACTURES, IMPENDING PATHOLOGIC FRACTURES, NONUNIONS AND MALUNIONS. THE DEVICE IS ALSO RECOMMENDED FOR USE WITH TECHNIQUE GUIDES AS WELL. THE RETURNED DEVICE SHOWS EVIDENCE OF SIGNIFICANT HAMMER MARKS TO THE MOST PROXIMAL LATERAL SURFACE OF THE HANDLE. HAMMERING OF THIS DEVICE IS NOT RECOMMENDED AND IF PERFORMED IN THE EVIDENT DIAGONAL DIRECTION, SUCH ANGLED FORCE WOULD BE TRANSFERRED TO CANNULATED TIP CAUSING IT TO BREAK OFF. DRAWINGS WERE REVIEWED AND DETERMINED TO BE SUITABLE FOR THE INTENDED DESIGN, APPLICATION, DIMENSIONAL AND MATERIAL CONFORMITY AND SUITABLE FOR THE INTENDED USE WHEN USED AS RECOMMENDED. 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. 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

    A PD EVALUATION WAS CONDUCTED. THE REPORT INDICATES THAT THE RETURNED AWL IS A DEVICE RECOMMENDED AS AN ALTERNATIVE TECHNIQUE FOR INITIAL OPENING OF THE MEDULLARY CANAL. GAGING BY THE PATIENTS AGE AND WEIGHT, IT IS LIKELY THAT AN ALFN PROCEDURE WAS PERFORMED. THE ADOLESCENT LATERAL FEMORAL NAIL (ALFN)EX IS INDICATED FOR USE IN ADOLESCENT AND SMALL-STATURE ADULT PATIENTS TO STABILIZE: FRACTURES OF THE FEMORAL SHAFT, SUBTROCHANTERIC FRACTURES, IPSILATERAL NECK/SHAFT FRACTURES, IMPENDING PATHOLOGIC FRACTURES, NONUNIONS AND MALUNIONS. THE DEVICE IS ALSO RECOMMENDED FOR USE WITH RAFN, LFRN &LFN AS WELL. THE RETURNED DEVICE SHOWS EVIDENCE OF SIGNIFICANT HAMMER MARKS TO THE MOST PROXIMAL LATERAL SURFACE OF THE HANDLE. HAMMERING OF THIS DEVICE IS NOT RECOMMENDED AND IF PERFORMED IN THE EVIDENT DIAGONAL DIRECTION, SUCH ANGLED FORCE WOULD BE TRANSFERRED TO CANNULATED TIP CAUSING IT TO BREAK OFF. THE RETURNED DEVICE WAS MANUFACTURED ON 6/4/2007 AND IS APPROXIMATELY 7 YEARS OLD. DRAWINGS WERE REVIEWED AND DETERMINED TO BE SUITABLE FOR THE INTENDED DESIGN, APPLICATION, DIMENSIONAL AND MATERIAL CONFORMITY AND SUITABLE FOR THE INTENDED USE WHEN USED AS RECOMMENDED. 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

    IT WAS REPORTED THAT A PRODUCT DEVELOPMENT ENGINEER REPORTS THAT THE SALES CONSULTANT CONTACTED HIM TO ASK FOR THE OVERALL LENGTH AND WIDTH OF THE 14MM CANNULATED AWL. THE SALES CONSULTANT TOLD HIM THAT THE AWL HAD BROKEN AND THE HOSPITAL REQUIRED THE LENGTH AND THE WIDTH OF THE ITEM. IT WAS REPORTED THAT A 14 MM CANNULATED AWL TIP BROKE OFF WHILE OPENING THE CANAL DURING SURGERY. PATIENT INVOLVEMENT AND THE 14MM CANNULATED AWL TIP REMAINED IN THE PATIENT. THE DOCTOR WAS PERFORMING A WIGGLING MOTION WITH THE 14MM CANNULATED AWL AND EVEN USED A MALLET WITH VERY SLIGHT TAPS UNTIL THE AWL BROKE. PATIENT OUTCOME AS EXPECTED DESPITE THE TIP OF THE AWL REMAINING IN THE PATIENT. NO SURGICAL DELAY. NO PATIENT DISCOMFORT OR PAIN. THIS IS REPORT NUMBER 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    589981 14.0MM CANNULATED AWL AWL HWJ SYNTHES HAGENDORF 1693318

    Patients

    Seq Age Sex Outcome Treatment
    1 14 YR