BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CANN SCREW MEASURING DEVICE FOR 6.5MM & 7.3MM CANN SCREWS

    MDR report key: 8038129 · Received November 5, 2018

    Report

    Report Number
    8030965-2018-57913
    Event Type
    Injury
    Date Received
    November 5, 2018
    Report Date
    October 18, 2018
    Manufacturer
    OBERDORF SYNTHES PRODUKTIONS GMBH
    Product Code
    HTJ
    UDI-DI
    07611819064850
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    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. IF THE INFORMATION IS UNKNOWN, NOT AVAILABLE OR DOES NOT APPLY, THE SECTION/FIELD OF THE FORM IS LEFT BLANK. DEVICE HISTORY LOT. PART: 391.700. LOT: 8871942. MANUFACTURING SITE: (B)(4). RELEASE TO WAREHOUSE DATE: 28.MAR.2014. THE DEVICE HISTORY RECORD SHOWS THIS LOT 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. VISUAL INSPECTION: THE RECEIVED DIRECT MEASURING DEVICE IS IN USED BUT STILL FAULTLESS CONDITION. FUNCTIONAL TEST: CARRIED OUT FUNCTIONAL TEST WAS PASSED SUCCESSFULLY THE RECEIVED DEVICE IS IN COMPLETE FAULTLESS CONDITION AND SHOWS CORRECT SCREW LENGTH. NO PRODUCT FAULT COULD BE IDENTIFIED. THEREFORE WE CANNOT REPLICATE THE COMPLAINED CONDITION. THIS COMPLAINT IS CLASSIFIED AS NOT CONFIRMED. NO FURTHER INVESTIGATIONS ARE REQUIRED. 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.

    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. CORRECTED DATA: INITIAL REPORTER TITLE AND NAME. 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

    THE DEVICE WAS 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 ON (B)(6) 2018, DURING AN OPEN REDUCTION INTERNAL FIXATION PROCEDURE, THE DIRECT MEASURING DEVICE SHOWED A DISCREPANCY IN MEASUREMENT. THE GUIDE WIRE INSERTED INTO THE PATIENT¿S BODY WAS MEASURED WITH A DIRECT MEASURING DEVICE. THE INDICATION ON THE MEASURING DEVICE WAS 5MM LONGER THAN THE ACTUAL (CORRECT) LENGTH. AN IMPLANT WAS SELECTED BASED ON THE MEASURED VALUE AND INSERTED INTO THE PATIENTS BODY. HOWEVER, DUE TO THE DISCREPANCY BETWEEN THE ACTUAL AND MEASURED VALUES, THE IMPLANT WAS LONGER THAN THE PROPER LENGTH. THUS, THE SURGEON HAD TO REPLACE THE IMPLANT WITH ANOTHER ONE OF CORRECT SIZE. THE SURGERY WAS COMPLETED WITH A 30-MINUTE SURGICAL DELAY. THERE WAS NO ADVERSE CONSEQUENCE TO THE PATIENT. CONCOMITANT DEVICE REPORTED: UNKNOWN GUIDE WIRE (PART #: UNKNOWN, LOT #: UNKNOWN, QUANTITY: 1). THIS REPORT IS FOR ONE (1) CANN SCREW MEASURING DEVICE FOR 6.5MM & 7.3MM CANN SCREWS. THIS IS REPORT 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    879999 CANN SCREW MEASURING DEVICE FOR 6.5MM & 7.3MM CANN SCREWS GAUGE,DEPTH HTJ OBERDORF SYNTHES PRODUKTIONS GMBH 8871942 07611819064850

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention