BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AIM-ARM F/DFN COMBINED F/PAD

    MDR report key: 7633990 · Received June 25, 2018

    Report

    Report Number
    8030965-2018-54574
    Event Type
    Malfunction
    Date Received
    June 25, 2018
    Date of Event
    May 29, 2018
    Report Date
    May 29, 2018
    Manufacturer
    OBERDORF SYNTHES PRODUKTIONS GMBH
    Product Code
    FZX
    UDI-DI
    07611819286283
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PATIENT INFORMATION IS UNKNOWN. DEVICE IS AN INSTRUMENT AND IS NOT IMPLANTED/EXPLANTED. DEVICE IS NOT DISTRIBUTED IN THE UNITED STATES, BUT IS SIMILAR TO DEVICE MARKETED IN THE USA. THE DEVICE WAS RECEIVED, THE INVESTIGATION COULD NOT BE COMPLETED, AND NO CONCLUSION COULD BE DRAWN, AS PRODUCT IS ENTERING THE COMPLAINT SYSTEM. A REVIEW OF THE DEVICE HISTORY RECORDS HAS BEEN REQUESTED. 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

    A DEVICE HISTORY RECORD (DHR) REVIEW WAS CONDUCTED FOR PART: 357.136, LOT: 2221713: MANUFACTURING SITE: (B)(4), RELEASE TO WAREHOUSE DATE: 27.SEP.2006: THE DEVICE HISTORY RECORD SHOWS THIS LOT OF (B)(4) PIECES WAS PROCESSED THROUGH THE NORMAL MANUFACTURING AND INSPECTION OPERATIONS WITH NO REWORK OR NONCONFORMITIES NOTED. THIS LOT MET ALL DIMENSIONAL, VISUAL AND FUNCTIONAL CRITERIA AT THE TIME OF RELEASE WITH NO ISSUES DOCUMENTED DURING THE MANUFACTURING PROCESS. REVIEW OF THE DEVICE HISTORY RECORD SHOWED THAT THERE WERE NO ISSUES DURING THE MANUFACTURE OF THIS PRODUCT WHICH WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. A PRODUCT INVESTIGATION WAS CONDUCTED. VISUAL INSPECTION: ALL RECEIVED PARTS ARE IN VERY USED CONDITION AND ARE RATHER OLD. MANY SIGNS OF OFTEN USE CAN BE IDENTIFIED. SIGNS OF HITS WITH HAMMER AND WEAR AND TEAR IN GENERAL COULD BE DOCUMENTED. FUNCTIONAL TEST: THE FUNCTIONAL TEST SHOWS THAT THE PROXIMAL AIMING DEVICE COULD NOT BE ASSEMBLED TO THE AIMING ARM AS INTENDED. THE CONNECTING PIN OF THE PROXIMAL AIMING DEVICE IS OUT OF ITS ORIGINAL POSITION. THEREFORE IT CANNOT BE INSERTED INTO THE CONNECTING HOLE ANYMORE. THE AIMING ARM IT SELVES COULD BE ASSEMBLED AS INTENDED AND IS STILL IN USABLE CONDITION EVEN LONG TERM IN USE AND WEAR AND TEAR. THE COMPLAINT DESCRIPTION CAN BE REPLICATED. AS IT IS NOT POSSIBLE TO ASSEMBLE THE DEVICES, THIS COMPLAINT IS CLASSIFIED AS CONFIRMED. AS THE PARTS HAVE BEEN SO MANY YEARS IN USE AND BECAUSE OF THE IDENTIFIED SIGNS WE IDENTIFY WEAR AND TEAR DURING MANY YEARS OF USE AS ROOT CAUSE FOR THIS COMPLAINT. THE PULL OUT OF THE CONNECTING PIN WAS CAUSED POST MANUFACTURING. THESE FINDINGS AND THE OVERALL APPEARANCE OF THE DEVICES SPEAK AGAINST A MANUFACTURING RELATED ISSUE. AS RESULT OF THE DOCUMENTED FACTS, NO FURTHER INVESTIGATIONS ARE REQUIRED. NO PRODUCT FAULT COULD BE IDENTIFIED. BASED ON THE INVESTIGATION FINDINGS, IT HAS BEEN DETERMINED THAT NO CORRECTIVE AND/OR PREVENTATIVE ACTION IS PROPOSED. 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 EUROPE REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2018, THE SURGERY WAS PERFORMED FOR SUPRACONDYLAR FEMUR FRACTURE. DURING THE SURGERY, IT WAS FOUND THAT PROXIMAL AIMING DEVICE WAS NOT WELL CONNECTED WITH AIMING ARM, THUS A GAP WAS GENERATED BETWEEN THE TWO DEVICES. DUE TO THIS EVENT THE SURGEON DID NOT USE THE DEVICES IN QUESTION. AS A RESULT, LOCKING AT PROXIMAL END WAS PERFORMED BY HAND. THE SURGERY WAS SUCCESSFULLY COMPLETED WITH A LESS THAN THIRTY (30) MINUTE DELAY, AND THERE WAS NO ADVERSE CONSEQUENCE TO THE PATIENT. CONCOMITANT DEVICES REPORTED: INSERTION HANDLE (PART 357.112, LOT 1076287, QUANTITY 1); INSTRUMENT (PART/LOT UNKNOWN, QUANTITY 1). THIS IS REPORT 2 OF 2 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    477103 AIM-ARM F/DFN COMBINED F/PAD GUIDE FZX OBERDORF SYNTHES PRODUKTIONS GMBH 2221713 07611819286283

    Patients

    Seq Age Sex Outcome Treatment
    1