BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    12.0MM CANNULATED AWL

    MDR report key: 5180851 · Received October 27, 2015

    Report

    Report Number
    3003875359-2015-10445
    Event Type
    Malfunction
    Date Received
    October 27, 2015
    Date of Event
    October 12, 2015
    Report Date
    October 12, 2015
    Manufacturer
    SYNTHES HAGENDORF
    Product Code
    HWJ
    PMA / PMN Number
    PEXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. DEVICE IS AN INSTRUMENT AND IS NOT IMPLANTED/EXPLANTED. A DEVICE HISTORY RECORD REVIEW WAS PERFORMED FOR THE SUBJECT DEVICE LOT. THE REVIEW SHOWED THAT THERE WERE NO ISSUES DURING THE MANUFACTURE OF THE PRODUCT THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. NO NON-CONFORMANCES WERE GENERATED DURING THE PRODUCTION OF THE SUBJECT DEVICE. THE 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

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS: A PRODUCT DEVELOPMENT INVESTIGATION WAS PERFORMED FOR THE SUBJECT DEVICE (12.0 MM CANNULATED AWL, PART NUMBER: 03.010.040, LOT NUMBER: 1776074, MANUFACTURING DATE: 16 NOV 2007) WAS RECEIVED WITH THE FOLLOWING COMPLAINT DESCRIPTION: ¿THE TIP OF A 12MM AWL FOR THE TIBIA NAIL SET WAS FOUND TO BE CHIPPED DURING THE STERILIZATION PROCESS¿. UPON VISUAL INSPECTION OF THE COMPLAINT DEVICE IT CAN BE SEEN THAT ON THE DISTAL END OF THE DEVICE THERE IS A SMALL CHIP ON THE AWL TIP OF THE INSTRUMENT, THUS CONFIRMING THE COMPLAINT DESCRIPTION. THE 12MM CANNULATED CAN BE UTILIZED IN SEVERAL DIFFERENT SYSTEMS INCLUDING TITANIUM CANNULATED TIBIAL NAILING SYSTEM; WHICH IS INDICATED TO STABILIZE FRACTURES OF THE PROXIMAL AND DISTAL TIBIA AND THE TIBIAL SHAFT, OPEN AND CLOSED TIBIAL SHAFT FRACTURES, CERTAIN PRE AND POSTISTHMIC FRACTURES, AND TIBIAL MALUNIONS AND NONUNIONS. THE AWL IS USED TO OPEN THE MEDULLARY CANAL PRIOR TO NAIL INSERTION PER THE TECHNIQUE GUIDE. THE DEVICE DRAWING WAS REVIEWED AS PART OF THE INVESTIGATION. THE DESIGN HISTORY WAS FOUND TO NOT IMPACT THE COMPLAINT CONDITION. 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 AND MAINTAINED AS RECOMMENDED. THE DEVICE HISTORY RECORD REVIEW (AS PREVIOUSLY REPORTED) REVEALED THAT NO NCRS WERE GENERATED DURING PRODUCTION. THE 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. THE RETURNED PART WAS DETERMINED TO BE SUITABLE FOR THE INTENDED USE WHEN EMPLOYED AND MAINTAINED AS RECOMMENDED. DURING THE INVESTIGATION NO PRODUCT DESIGN ISSUES OR DISCREPANCIES WERE OBSERVED THAT MAY HAVE CONTRIBUTED TO THE COMPLAINT CONDITION. A ROOT CAUSE COULD NOT BE DETERMINED, MOST LIKELY ROUGH HANDLING OR THE USE OF EXCESSIVE FORCE DURING SURGERIES OVER THE DEVICE¿S 8 YEAR LIFESPAN LED TO THE COMPLAINT DESCRIPTION. EVENT DATE: UNKNOWN. THE DATE OF THIS REPORT WAS MISTAKENLY POPULATED AS THE EVENT DATE ON THE INITIAL MEDWATCH REPORT AND WAS OCT 12, 2015. REPORT WAS INITIALLY SUBMITTED ON NOV 24, 2014 BUT THE REPORT DID NOT PASS THE FIRST ACKNOWLEDGEMENT IN THE FDA PORTAL. ADVISED BY FDA ON DECEMBER 9, 2015 TO RESUBMIT MEDWATCH. 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 TIP OF A 12MM AWL FOR THE TIBIA NAIL SET WAS FOUND TO BE CHIPPED DURING THE STERILIZATION PROCESS. IT IS UNKNOWN WHEN THE AWL BECAME CHIPPED. THERE WAS NO REPORT OF PATIENT/SURGICAL INVOLVEMENT. THIS REPORT IS 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    710359 12.0MM CANNULATED AWL AWL HWJ SYNTHES HAGENDORF 1776074

    Patients

    Seq Age Sex Outcome Treatment
    1