BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RETRACTOR BODY

    MDR report key: 10480287 · Received September 1, 2020

    Report

    Report Number
    8030965-2020-06536
    Event Type
    Malfunction
    Date Received
    September 1, 2020
    Report Date
    August 7, 2020
    Manufacturer
    OBERDORF SYNTHES PRODUKTIONS GMBH
    Product Code
    GAD
    UDI-DI
    07611819518605
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    DEPUY SYNTHES IS SUBMITTING THIS REPORT PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH DEPUY SYNTHES HAS NOT BEEN ABLE TO INVESTIGATE OR VERIFY PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY FDA, DEPUY SYNTHES OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE DEVICE, DEPUY SYNTHES, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. H10 ADDITIONAL NARRATIVE: H3, H4, H6 INVESTIGATION SUMMARY. VISUAL INSPECTION: THE DEVICE RECEIVED IN HAGENDORF SITE "RETRACTOR BODY" 03.816.001 WITH LOT NUMBER 8120144 IS IN PROPER CONDITIONS. NO SCRATCHES OR SIGNS OF HEAVY USE OR DAMAGE ARE PRESENT ON THE DEVICE. FUNCTIONAL TEST: FUNCTIONAL TESTS WERE PERFORMED ON THE DEVICE ("RETRACTOR BODY" 03.816.001 WITH LOT NUMBER 8120144) ACCORDING TO INSPECTION SHEET THE FOLLOWING FUNCTIONAL TESTS WERE PERFORMED: FUNCTIONAL TEST: ASSEMBLY AND DISASSEMBLY USING FUNCTION GAUGE . FUNCTIONAL TEST: THIRD ARM: ASSEMBLY AND DISASSEMBLY USING FUNCTION GAUGE . MANUAL/ VISUAL TEST: HANDLES MUST BE ABLE TO TURN FREELY AROUND THEIR OWN FIXING AXIS. MANUAL/ VISUAL TEST: WHEN THE HANDLES ARE PRESSED TOGETHER, THE SPEED NUT MUST ALLOW THE ADJUSTMENT OF THE HANDLES. SINCE THE DEVICE ANALYZED PASSED ALL THE TEST PERFORMED, THE COMPLAINT COULD NOT BE REPLICATED. THE BLADE HOLDER CAN BE PROPERLY CONNECTED WITH THE RETRACTOR. SUMMARY: THE COMPLAINT IS RATED AS UNCONFIRMED SINCE THE DEVICE IS FUNCTIONAL AS REQUIRED. IN HINDSIGHT, AND WITH THE PROVIDED INFORMATION, IT IS NOT POSSIBLE TO DETERMINE THE EXACT CAUSE OF THE COMPLAINED ISSUE. WE ONLY CAN ASSUME THAT DURING THE OPERATION AN APPLICATION ERROR MAY HAVE TAKEN PLACE. NO MANUFACTURING RELATED ISSUES COULD BE DETECTED. 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. THE ROOT CAUSE WAS IDENTIFIED DURING THE PERFORMED EVALUATION AND THEREFORE THE IN THE INVESTIGATION FLOWS LISTED REMAINING INVESTIGATION STEPS ARE NOT REQUIRED. ADDITIONAL MONITORING FOR ANY POTENTIAL SAFETY SIGNALS WILL BE CONDUCTED THROUGH COMPLAINT TRENDING AND OTHER POST MARKET SAFETY SURVEILLANCE ACTIVITIES. FOR THE DETAILED INVESTIGATION AND PICTURES PLEASE SEE IN THE ATTACHMENT DEVICE HISTORY: PRODUCT CODE: 03.816.001; LOT #: 8120144; MANUFACTURING SITE: HÄGENDORF; RELEASE TO WAREHOUSE DATE: 08. APRIL 2013. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE LOT NUMBER, AND NO NON-CONFORMANCES 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.

    Additional Manufacturer Narrative · 1

    REPORTER IS A SALES REPRESENTATIVE. THE DEVICE HAS BEEN RECEIVED, THE INVESTIGATION IS IN PROGRESS, NO CONCLUSION COULD BE DRAWN AT THE TIME OF FILING THIS REPORT. 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 DURING THE DEMO ON AN UNKNOWN DATE, THE BLADE HOLDER WAS NOT ENGAGING WITH THE BLADE AND SALES REP WAS UNABLE TO ACTUALLY PUT TOGETHER THE RETRACTOR. THERE WAS NO PATIENT INVOLVEMENT REPORTED. THIS REPORT IS FOR ONE (1) RETRACTOR BODY. THIS IS REPORT 2 OF 3 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    939805 RETRACTOR BODY RETRACTOR GAD OBERDORF SYNTHES PRODUKTIONS GMBH 8120144 07611819518605

    Patients

    Seq Age Sex Outcome Treatment
    1 BLADE HOLDER LE F/03.816.001| UNK - SCREWS