BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    2.0MM ANGLED AWL

    MDR report key: 4845597 · Received June 15, 2015

    Report

    Report Number
    2520274-2015-14477
    Event Type
    Malfunction
    Date Received
    June 15, 2015
    Report Date
    June 15, 2015
    Manufacturer
    SYNTHES HAGENDORF
    Product Code
    OVE
    PMA / PMN Number
    PK112459
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. NO PATIENT INVOLVEMENT . DEVICE IS AN INSTRUMENT AND IS NOT IMPLANTED/EXPLANTED. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. A REVIEW OF THE DEVICE HISTORY RECORDS HAS BEEN REQUESTED FOR: PART 03.617.993, LOT 3550003. 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: SUBJECT DEVICE HAS BEEN RECEIVED AND IS CURRENTLY IN THE EVALUATION PROCESS. INVESTIGATION IS ONGOING; NO CONCLUSION COULD BE DRAWN AS PRODUCT IS ENTERING THE COMPLAINT SYSTEM. A DEVICE HISTORY RECORDS WAS CONDUCTED. THE REPORT INDICATES THAT THE MANUFACTURING LOCATION: (B)(4), MANUFACTURING DATE: 09.SEP.2010, 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. 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

    PRODUCT INVESTIGATION SUMMARY: A 2.0MM ANGLED AWL (03.617.993 / LOT 3009347) AND A PROBE WITH 1.8MM CANNULA (03.600.033 / LOT 6835317) WERE RETURNED WITH BROKEN AND BENT TIPS RESPECTIVELY. THE INSTRUMENTS WERE NOT INVOLVED IN A SPECIFIC PROCEDURE. A DEFINITIVE ROOT CAUSE WAS UNABLE TO BE DETERMINED IN EITHER INSTANCE; HOWEVER, IN BOTH INSTANCES, METHOD OF USE RATHER THAN A DESIGN/MANUFACTURING DEFICIENCY LED TO THE COMPLAINT CONDITION. THE ANGLED AWL WAS RECEIVED UNDER THE COMPLAINT CONDITION ¿BROKEN ¿ INTRAOPERATIVELY.¿ THE INSTRUMENT WAS RETURNED WITH A SHEARED OFF TIP ON THE DISTAL END OF THE DEVICE. THE BROKEN OFF PIECE WAS NOT RETURNED. THE MATERIAL AT THE FRACTURE SITE APPEARS TO BE HOMOGENEOUS UNDER MAGNIFICATION; THEREFORE, IT IS UNLIKELY THAT A MATERIAL IMPERFECTION LED TO THE PART FAILURE. NO NON-CONFORMANCE REPORTS WERE GENERATED DURING PRODUCTION. THE APPLICATION OF EXCESSIVE AND/OR OFF-AXIS LOADING COULD CAUSE THE COMPLAINT CONDITION IN BOTH CASES. THE ASSOCIATED DRAWINGS FOR THE 2.0MM ANGLED AWL WERE REVIEWED, SPECIFICALLY THOSE RELATED TO THE SHAFT AND THE PENETRATING TIP. ADDITIONALLY THE TOP LEVEL DRAWING WAS REVIEWED. 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

    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 THE TIP IS BROKEN OFF OF AN ANGLED AWL. ALSO, IT WAS REPORTED A CANNULATED PROBE IS BENT. NO PROCEDURE OR PATIENT INVOLVEMENT. THESE WERE IDENTIFIED DURING INSPECTION OF FIELD EQUIPMENT. NO ADDITIONAL INFORMATION. THIS REPORT IS 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    389633 2.0MM ANGLED AWL INTERVERTEBRAL FUSION DEVICE W/INTEGRATED FIXATION,CERVICAL OVE SYNTHES HAGENDORF 3550003

    Patients

    Seq Age Sex Outcome Treatment
    1