BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SHAFT FOR 90° SCREWDRIVER

    MDR report key: 5068112 · Received September 10, 2015

    Report

    Report Number
    2520274-2015-15783
    Event Type
    Malfunction
    Date Received
    September 10, 2015
    Date of Event
    August 31, 2015
    Report Date
    August 31, 2015
    Manufacturer
    SYNTHES OBERDORF
    Product Code
    DZI
    PMA / PMN Number
    PK082649
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT INVESTIGATION SUMMARY: THE RETURNED INSTRUMENT WAS EVALUATED AND THE COMPLAINT CONDITION WAS ABLE TO BE CONFIRMED AS THE INNER-SHAFTS WERE DAMAGED. LOT 8062742 WAS RETURNED WITH A DAMAGED PROXIMAL BEARING. A DEFINITIVE ROOT CAUSE WAS UNABLE TO BE DETERMINED; HOWEVER, THE COMPLAINT CONDITION IS CONSISTENT USING A DRIVE UNIT WITH TOO HIGH SPEED (RPM). THE SHAFT FOR 90 DEGREE SCREWDRIVER (PART 03.505.003) IS A COMPONENT OF THE 90 DEGREE SCREWDRIVER ASSEMBLY, WHICH CAN BE UTILIZED FOR PRE-DRILLING AND SCREW INSERTION IN AREAS WHERE SPACE IS LIMITED: ORAL AND MAXILLOFACIAL SURGERY. THE RETURNED INSTRUMENTS WERE EVALUATED AND THE COMPLAINT CONDITION WAS ABLE TO BE CONFIRMED IN EACH INSTANCE AS BOTH RETURNED INNER-SHAFTS WERE DAMAGED. THE RELEVANT DRAWINGS FOR THE RETURNED INSTRUMENT WERE REVIEWED. THE DESIGN, MATERIALS, AND FINISHING PROCESSES WERE FOUND TO BE APPROPRIATE FOR THE INTENDED USE OF THESE DEVICES. A DEVICE HISTORY REVIEW WAS PERFORMED FOR THE RETURNED INSTRUMENT¿S LOT NUMBER AND NO MATERIAL RECORD REPORTS, NON-CONFORMANCE REPORTS, OR COMPLAINT-RELATED ISSUES WERE IDENTIFIED. DEVICE HISTORY RECORD REVIEW: MANUFACTURING LOCATION: (B)(4) - MANUFACTURING DATE: DECEMBER 11, 2006. NO NON-CONFORMANCE REPORTS 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 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 LOT NUMBER OF 8062752 WAS PROVIDED; HOWEVER, IT APPEARS TO BE INVALID BASED ON THE REPORTED PART NUMBER FOR THE DEVICE. DEVICE IS AN INSTRUMENT AND IS NOT IMPLANTED OR EXPLANTED. THE COMPLAINANT PART HAS NOT BEEN RECEIVED FOR MANUFACTURER REVIEW/INVESTIGATION. THE DEVICE IS ALSO LISTED AS BEING ¿EXEMPT.¿ SINCE A 510K NUMBER WAS PROVIDED, IT HAS BEEN REPORTED IN THE ASSOCIATED FIELD. INVESTIGATION COULD NOT BE COMPLETED AND NO CONCLUSION COULD BE DRAWN AS NO DEVICE WAS RETURNED. WITHOUT A VALID LOT NUMBER, THE DEVICE HISTORY RECORD REVIEW COULD NOT BE REQUESTED. DEVICE HISTORY REVIEW: COMPLETION OF A RECORD REVIEW COULD NOT BE DONE DUE TO THE INVALID PART/LOT NUMBER COMBINATION. 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

    THE DEVICE WAS RECEIVED, THE INVESTIGATION COULD NOT BE COMPLETED, AND NO CONCLUSION COULD BE DRAWN, AS PRODUCT IS ENTERING THE COMPLAINT SYSTEM. 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

    PERFORMED SURGICAL PROCEDURE: OPEN REDUCTION INTERNAL FIXATION (ORIF).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A BACKUP SCREWDRIVER SHAFT WAS USED DURING A SURGICAL PROCEDURE ON (B)(6) 2015. THE BRACKET ON THIS DEVICE WAS BROKEN, BUT NO FRAGMENTS WERE LEFT IN THE PATIENT. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH A ONE (1) MINUTE SURGICAL DELAY. THIS REPORT IS 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    600864 SHAFT FOR 90° SCREWDRIVER DRILL, BONE, POWERED DZI SYNTHES OBERDORF 8062742

    Patients

    Seq Age Sex Outcome Treatment
    1 38 YR