BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CONICAL EXTRACTION SCREW FOR 3.5MM SCREWS

    MDR report key: 8651511 · Received May 29, 2019

    Report

    Report Number
    8030965-2019-64656
    Event Type
    Malfunction
    Date Received
    May 29, 2019
    Report Date
    April 30, 2019
    Manufacturer
    OBERDORF SYNTHES PRODUKTIONS GMBH
    Product Code
    HWB
    UDI-DI
    07611819204409
    PMA / PMN Number
    EXEMPT
    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. UPON VISUAL INSPECTION, THE DISTAL TIP OF THE DEVICE HAD STRIPPED THREADS. THERE WAS ALSO DISCOLORATION NOTED. THERE REMAINING OF THE DEVICE SHOWED SURFACE WEAR CONSISTENT WITH USE WHICH WOULD NOT IMPACT THE FUNCTIONALITY OF THE DEVICE. 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 STRIPPED THREAD, 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. 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 HISTORY LOT, PART: 309.521, LOT: 9771187, MANUFACTURING SITE: (B)(4), RELEASE TO WAREHOUSE DATE: 29. FEB. 2016. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE LOT NUMBER, AND NO NON-CONFORMANCE'S WERE IDENTIFIED. 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 SYNTHES REPORTS AN EVENT IN (B)(6) 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. CONCOMITANT DEVICE: UNKNOWN SCREW (PART# UNKNOWN, LOT# UNKNOWN, QUANTITY# UNKNOWN). THIS REPORT IS FOR ONE (1) CONICAL EXTRACTION SCREW FOR 3.5MM SCREWS. THIS IS REPORT 3 OF 4 FOR (B)(4). THIS COMPLAINT HAS BEEN UPDATED WITH THE 4 OF 14 DEVICES. PLEASE SEE THE LINKED COMPLAINT (B)(4) FOR THE ADDITIONAL TEN DEVICES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    445747 CONICAL EXTRACTION SCREW FOR 3.5MM SCREWS EXTRACTOR HWB OBERDORF SYNTHES PRODUKTIONS GMBH 9771187 07611819204409

    Patients

    Seq Age Sex Outcome Treatment
    1