BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SMALL HEXAGONAL SCREWDRIVER 2.5MM WIDTH ACROSS FLATS

    MDR report key: 8650093 · Received May 29, 2019

    Report

    Report Number
    8030965-2019-64628
    Event Type
    Malfunction
    Date Received
    May 29, 2019
    Report Date
    April 2, 2019
    Manufacturer
    OBERDORF SYNTHES PRODUKTIONS GMBH
    Product Code
    HXX
    UDI-DI
    07611819248465
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    INITIAL REPORTER IS SYNTHES SALES REPRESENTATIVE. DEVICE IS NOT DISTRIBUTED IN THE UNITED STATES, BUT IS SIMILAR TO DEVICE MARKETED IN THE USA. DEVICE HISTORY RECORDS REVIEW WAS COMPLETED FOR PART: 314.036, LOT: L210974. MANUFACTURING LOCATION: (B)(4), RELEASE TO WAREHOUSE DATE: DEC 29, 2016. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE LOT NUMBER, AND NO NON-CONFORMANCE WERE IDENTIFIED. PRODUCT INVESTIGATION WAS COMPLETED. THE DISTAL TIP OF THE COMPLAINED SCREWDRIVER IS BADLY WORN. BECAUSE OF THE DAMAGES, THE COMPLAINT RELEVANT DIMENSIONS CANNOT BE CHECKED TO PRINT SPECIFICATIONS ANYMORE. THE MANUFACTURING REVIEW SHOWS THAT THE PRODUCTION PROCEDURE WAS ACCORDING TO THE SPECIFICATIONS AND THERE WERE NO ISSUES THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. DUE TO THE WORN OUT TIP, THE COMPLAINT CONDITION IS RATED AS CONFIRMED. BECAUSE OF THE DAMAGE, IT IS NOT POSSIBLE TO MEASURE THE RELEVANT DIMENSION. THE DAMAGE IS CLEARLY CAUSED POST MANUFACTURING. DUE TO THE DAMAGE SIGNS WE CAN ASSUME THAT THIS PRODUCT WAS AN OFTEN AND INTENSIVE USED INSTRUMENT. THE DAMAGE AT THE TIP INDICATES THAT A MECHANICAL OVERLOADING SITUATION DURING ITS USE COULD LIKELY CAUSED THE DEFORMATION OF THE TIP. AS PER THE RELEVANT LEAFLET ¿IMPORTANT INFORMATION¿ : END OF LIFE OF A DEVICE IS NORMALLY DETERMINED BY WEAR AND DAMAGE DUE TO USE. EVIDENCE OF DAMAGE AND WEAR ON A DEVICE MAY INCLUDE BUT IS NOT LIMITED TO CORROSION (I.E. RUST, PITTING), DISCOLORATION, EXCESSIVE SCRATCHES, FLAKING, WEAR AND CRACKS. IMPROPERLY FUNCTIONING DEVICES, DEVICES WITH UNRECOGNIZABLE MARKINGS, MISSING OR REMOVED (BUFFED OFF) PART NUMBERS, DAMAGED AND EXCESSIVELY WORN DEVICES SHOULD NOT BE USED. BASED ON THE INVESTIGATION FINDINGS, IT HAS BEEN DETERMINED THAT NO CORRECTIVE AND/OR PREVENTATIVE ACTION IS PROPOSED AS NO PRODUCT RELATED ISSUE COULD BE DETECTED. 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

    DEVICE REPORT FROM (B)(6) REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON AN UNKNOWN DATE, A PATIENT UNDERWENT AN OSTEOSYNTHESIS SURGERY WITH THE PROXIMAL HUMERUS INTERNAL LOCKING SYSTEM (PHILOS) DUE TO A FRACTURE. DURING THE IMPLANTATION OF THE PROXIMAL HUMERAL PLATE, IT WAS IMPOSSIBLE TO REMOVE THE PLATE FROM THE INSERTION HANDLE. THE SURGEON REMOVED THE IMPLANTED PLATE DUE TO IT WAS IMPOSSIBLE TO DETACH THE INSERTION HANDLE AND ANOTHER PLATE WAS IMPLANTED BUT NOT MINI-INVASIVE. THERE WAS A SURGICAL DELAY OF AT LEAST 2 HOURS. PROCEDURE AND PATIENT OUTCOME ARE UNKNOWN. DUE TO SYSTEM LIMITATION, THIS EVENT IS CAPTURED UNDER THIS (B)(4). CONCOMITANT DEVICE: SCREW (PART UNKNOWN, LOT UNKNOWN, QUANTITY UNKNOWN). THIS REPORT IS FOR ONE (1) SCREWDRIVER. THIS IS REPORT 6 OF 10 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    444038 SMALL HEXAGONAL SCREWDRIVER 2.5MM WIDTH ACROSS FLATS SCREWDRIVERS HXX OBERDORF SYNTHES PRODUKTIONS GMBH L210974 07611819248465

    Patients

    Seq Age Sex Outcome Treatment
    1