BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    14.0MM CANNULATED AWL

    MDR report key: 6193328 · Received December 21, 2016

    Report

    Report Number
    3003875359-2016-10655
    Event Type
    Malfunction
    Date Received
    December 21, 2016
    Report Date
    November 30, 2016
    Manufacturer
    SYNTHES HAGENDORF
    Product Code
    HWJ
    UDI-DI
    10886982067142
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL NARRATIVE: DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. NO PATIENT INVOLVEMENT. IT IS UNKNOWN WHEN BREAKAGE OCCURRED. DEVICE IS AN INSTRUMENT AND IS NOT IMPLANTED/EXPLANTED. A REVIEW OF THE DEVICE HISTORY RECORDS HAS BEEN COMPLETED. MANUFACTURING LOCATION: (B)(4), MANUFACTURING DATE: AUGUST 28, 2006. NO NON-CONFORMANCE RECORDS 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. 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

    PRODUCT DEVELOPMENT INVESTIGATION WAS PERFORMED ON THE RETURNED SUBJECT DEVICE (14.0MM CANNULATED AWL, PART # 03.010.041, LOT # 1544254). THE COMPLAINT CONDITION IS CONFIRMED AS THE AWL WAS RECEIVED WITH A SMALL SEMI-CIRCULAR PORTION, APPROXIMATELY 2.5MM ACROSS AND 1.5MM DEEP, BROKEN FROM THE DISTAL TIP OF THE DEVICE. THE BROKEN PORTION WAS NOT RECEIVED. A DEVICE HISTORY RECORD (DHR) REVIEW, VISUAL INSPECTION, AND DRAWING REVIEW WERE PERFORMED AS PART OF THIS INVESTIGATION. THE RETURNED PART WAS DETERMINED TO BE SUITABLE FOR THE INTENDED USE WHEN EMPLOYED AS RECOMMENDED. THE RETURNED AWL (03.010.041) IS INCLUDED IN A VARIETY OF TRAUMA NAIL SETS, INCLUDING THE TITANIUM CANNULATED RETROGRADE/ANTEGRADE FEMORAL NAIL (RAFN), TITANIUM CANNULATED ADOLESCENT LATERAL ENTRY FEMORAL NAIL, AND THE TITANIUM CANNULATED LATERAL ENTRY FEMORAL RECON NAIL SYSTEMS. THE TECHNIQUE GUIDE FOR THE TITANIUM CANNULATED RAFN STATES THAT THE AWL (03.010.041) IS USED OVER A GUIDE WIRE AND IS AN ALTERNATIVE INSTRUMENT DESIGNED TO MANUALLY OPEN THE MEDULLARY CANAL FOR 9.0MM TO 13.0MM NAILS. THE AWL WAS RECEIVED WITH A SMALL SEMI-CIRCULAR PORTION, APPROXIMATELY 2.5MM ACROSS AND 1.5MM DEEP, BROKEN FROM THE DISTAL TIP OF THE DEVICE. THE BROKEN PORTION WAS NOT RECEIVED. THE FOUR (4) DISTAL SHARP EDGES SHOW WEAR AND SMALL NICKS OVER THE FULL LENGTH. ON THE PROXIMAL END AN AREA OF FLATTENING WAS OBSERVED CONSISTENT WITH LIGHT IMPACT. THUS, THE COMPLAINT CONDITION IS CONFIRMED AND CONSISTENT WITH THE REPORTED CONDITION. REPLICATION OF THE COMPLAINT CONDITION IS NOT APPLICABLE AS THE DEVICE IS ALREADY BROKEN. BASED ON THE DATE OF MANUFACTURED (28.AUG.2006) THE DRAWINGS 14MM CANNULATED AWL AND AWE TIP (COMPONENT), REFLECTING THE CURRENT AND MANUFACTURED REVISION, WERE REVIEWED. DURING THE INVESTIGATION NO PRODUCT DESIGN ISSUES OR DISCREPANCIES WERE OBSERVED THAT MAY HAVE CONTRIBUTED TO THE COMPLAINT CONDITION. THE RETURNED PART WAS DETERMINED TO BE SUITABLE FOR THE INTENDED USE WHEN EMPLOYED AS RECOMMENDED. NO DEFINITIVE ROOT CAUSE WAS ABLE TO BE DETERMINED AS CIRCUMSTANCES SURROUNDING THE EVENT AND OVER THE DEVICES ROUGHLY 10+ YEAR LIFESPAN ARE UNKNOWN. THE RETURNED PART WAS DETERMINED TO BE SUITABLE FOR THE INTENDED USE WHEN EMPLOYED 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 AN AWL WAS DISCOVERED BROKEN IN A STORAGE WAREHOUSE OUTSIDE OF HOSPITAL. NO PATIENT INVOLVEMENT WAS REPORTED. THIS IS REPORT 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    843277 14.0MM CANNULATED AWL AWL HWJ SYNTHES HAGENDORF 1544254 10886982067142

    Patients

    Seq Age Sex Outcome Treatment
    1