BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    114.0MM CANNULATED AWL

    MDR report key: 4361361 · Received December 24, 2014

    Report

    Report Number
    8030965-2014-10840
    Event Type
    Malfunction
    Date Received
    December 24, 2014
    Report Date
    November 26, 2014
    Manufacturer
    SYNTHES HAGENDORF
    Product Code
    HWJ
    PMA / PMN Number
    PEXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. DEVICE IS AN INSTRUMENT AND IS NOT IMPLANTED/EXPLANTED. SYNTHES (B)(4) SUPPLIED THE 14MM CANNULATED AWL, PART #03.010.040, AND LOT #1466389 ON PO #(B)(4) DELIVERED (B)(6) 2006 FOR (B)(4) PIECES TO SYNTHES LOT #5248603 AND ON PO #(B)(4) DELIVERED (B)(6) 2006 FOR (B)(4) PIECES TO SYNTHES LOT #5248606. INITIALLY, THE PARTS CONFORMED TO THE SYNTHES FINAL INSPECTION SHEET #(B)(4), REVISION ¿(B)(4)¿. THE PARTS WERE RELEASED TO THE WAREHOUSE ON (B)(6) 2006 (LOT #5248606) AND ON (B)(6) 2006 (LOT #5248603). THERE WERE NO MATERIAL REVIEW REPORTS, NON-CONFORMANCE REPORTS, OR COMPLAINT RELATED ISSUES WITH THIS LOT. THE 14MM CANNULATED AWL WAS MADE TO THE SYNTHES DRAWING P/N (B)(4), REVISION ¿(B)(4)¿, RELEASED ON (B)(6) 2005. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. 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 HISTORY RECORDS WAS CONDUCTED. THE REPORT INDICATES THAT THE: MANUFACTURING LOCATION: (B)(4), MANUFACTURING DATE: 09 MAY 2006, 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. 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

    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 PRODUCT DEVELOPMENT EVALUATION WAS PERFORMED FOR THE SUBJECT DEVICE. THE RETURNED 14MM CANNULATED AWL (03.010.041) (1466389) WAS RECEIVED SHOWING EVIDENCE OF APPARENT HAMMER MARKS ON THE HANDLE, ALSO THE EDGES OF ITS TIP INDICATED SOME DAMAGE, AND A PORTION OF ITS TIP WAS BROKEN OFF. THE RETURNED AWL IS INCLUDED IN A VARIETY OF TRAUMA NAIL SETS, INCLUDING THE TITANIUM CANNULATED/RETROGRADE/ANTEGRADE FEMORAL NAIL, TITANIUM CANNULATED ADOLESCENT LATERAL ENTRY FEMORAL NAIL, AND THE TITANIUM CANNULATED LATERAL ENTRY FEMORAL RECON NAIL SYSTEMS. THE TECHNIQUE GUIDE FOR THE TITANIUM CANNULATED RETROGRADE/ANTEGRADE FEMORAL NAIL) STATES THAT THE AWL (03.010.041) IS USED AS AN ALTERNATIVE INSTRUMENT DESIGNED TO MANUALLY OPEN THE MEDULLARY CANAL FOR 9.0MM TO 13.0MM NAILS. THE RETURNED AWL WAS MANUFACTURED IN 05/2006, THEREFORE THE ASSOCIATED DRAWINGS WERE REVIEWED AND DETERMINED TO BE SUITABLE FOR THE INTENDED DESIGN, APPLICATION, AND DIMENSIONAL CONFORMITY WHEN USED AND HANDLED AS RECOMMENDED. HAMMER MARKS WERE NOTICED ON THREE DIFFERENT AREAS OF THE AWL HANDLE. HAMMERING OF THE RETURNED AWL IS NOT RECOMMENDED. UNINTENDED FORCES FROM HAMMERING, ESPECIALLY OFF-AXIS STRIKES, COULD BE TRANSFERRED TO THE CANNULATED TIP OF THE AWL WHICH CAN CAUSE IT TO BREAK OFF AS IT DID IN THE SUBJECT COMPLAINT. THE REPORTED COMPLAINT CONDITION WAS CONFIRMED. ADDITIONAL MANUFACTURING DATE FOR SUPPLIER LOT NUMBER 1466389 IS MAY 20, 2006. A REVIEW OF THE DEVICE HISTORY RECORDS WAS PERFORMED AND REVEALED 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.

    Additional Manufacturer Narrative · 1

    DEVICE RETURNED TO MANUFACTURER ON JANUARY 5, 2015; PENDING INVESTIGATION. SUBJECT DEVICE HAS BEEN RECEIVED AND IS CURRENTLY IN THE EVALUATION PROCESS. INVESTIGATION IS ONGOING; NO CONCLUSION COULD BE DRAWN. 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 THE 14.0MM CANNULATED AWL SMALL TIP BROKE OFF IN SURGERY. REPORTEDLY THERE WAS NO PATIENT HARM, NO DELAY IN SURGERY AND NO FRAGMENTS LEFT IN THE MALE PATIENT THIS IS REPORT 1 OF 1 FOR COM-(B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    849328 114.0MM CANNULATED AWL AWL HWJ SYNTHES HAGENDORF 1466389

    Patients

    Seq Age Sex Outcome Treatment
    1