BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SHAFT F/AWL F/04.630.135S

    MDR report key: 7512379 · Received May 14, 2018

    Report

    Report Number
    8030965-2018-53750
    Event Type
    Injury
    Date Received
    May 14, 2018
    Date of Event
    April 18, 2018
    Report Date
    April 18, 2018
    Manufacturer
    OBERDORF SYNTHES PRODUKTIONS GMBH
    Product Code
    HWJ
    UDI-DI
    07611819588028
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    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. 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. ADDITIONAL NARRATIVE: LOT NUMBER, CONCOMITANT MEDICAL PRODUCTS. DEVICE EVALUATED BY MFR, DEVICE MANUFACTURE DATE: PART: 03.630.144, LOT: 1502741: MANUFACTURING SITE: SELZACH. SUPPLIER: BAECHLER FEINTECH AG. RELEASE TO WAREHOUSE DATE: JULY 02, 2015. THE DEVICE HISTORY RECORD SHOWS THIS LOT OF DEVICES WAS PROCESSED THROUGH THE NORMAL MANUFACTURING AND INSPECTION OPERATIONS WITH NO REWORK OR NONCONFORMITIES NOTED. THIS LOT MET ALL DIMENSIONAL, VISUAL, MATERIAL AND HARDNESS 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. DEVICE EVALUATED BY MFR: A PRODUCT INVESTIGATION WAS COMPLETED: THE VISUAL INSPECTION HAS SHOWN THAT A PIECE OF ABOUT SIX (6) MILLIMETERS LENGTH IS BROKEN OFF. THE REMAINED OF THE AWL IS STRONGLY TWISTED IN CLOCKWISE DIRECTION. DUE TO THE ABOVE DESCRIBED DAMAGES THE RELEVANT DIMENSIONS CANNOT BE VERIFIED ANYMORE. NO DEVIATIONS REGARDING DIMENSION WERE FOUND DURING THE REVIEW OF THE MANUFACTURING DOCUMENTS. NO DEVIATIONS REGARDING MATERIAL OR HARDNESS WERE FOUND DURING THE REVIEW OF THE MANUFACTURING DOCUMENTS. THE FRACTURE FACE IS HOMOGENEOUS, WHICH INDICATES MATERIAL CONFORMITY, AND HAS THE TYPICAL VIEW OF A FORCED RUPTURE. THE COMPLAINT IS CONFIRMED AS THE AWL IS BROKEN AS COMPLAINED. BASED ON THE APPEARANCE OF THE AWL IT CAN BE CONCLUDED THAT THERE WAS A VERY STRONG METALLIC CONTACT DURING THE INSERTION. DUE TO THIS CONTACT THE AWL DID GET TWISTED FIRST AND FINALLY BROKE DUE TO A MECHANICAL OVERLOAD. ACCORDING TO THE COMPLAINT DESCRIPTION, THE REQUIRED HANDLE NOT AVAILABLE IN THE SET. BUT THERE WAS NO FURTHER INFORMATION PROVIDED HOW THE ISSUE WITH THE MISSING HANDLE WAS FINALLY SOLVED AND HOW THE AWL WAS INSERTED WITHOUT THE HANDLE. THEREFORE, IT IS LIKELY THAT THE MISSING HANDLE DID CONTRIBUTE TO THE COMPLAINED MALFUNCTION. 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 · 0

    IT WAS REPORTED THE SURGERY TIME WAS EXTENDED BUT IT IS UNKNOWN THE LENGTH OF THE DELAY.

    Additional Manufacturer Narrative · 1

    PATIENT INFORMATION WAS NOT PROVIDED FOR REPORTING. DEVICE IS AN INSTRUMENT AND IS NOT IMPLANTED / EXPLANTED. DEVICE IS EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION, BUT HAS NOT BEEN RECEIVED YET. REPORTER FACILITY CONTACT NUMBER WAS NOT PROVIDED. DEVICE IS NOT DISTRIBUTED IN THE UNITED STATES, BUT IS SIMILAR TO DEVICE MARKETED IN THE USA. DEVICE EVALUATION/INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN AS PRODUCT WAS NOT RETURNED TO MANUFACTURER. ADDITIONALLY, DEVICE HISTORY RECORDS REVIEW COULD NOT BE COMPLETED WITHOUT LOT NUMBER. 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, DURING THE SURGERY, IT WAS NOTED THAT THE HANDLE FOR THE AWL THAT PREPARES THE BONE BED FOR SCREW INSERTION WAS MISSING FROM THE LOAN TRAY. THE SURGEON SUBSEQUENTLY TRIED TO USE IT WITHOUT THE HANDLE BUT THE TIP OF THE SHAFT SNAPPED OFF IN PATIENT. THIS COULD NOT BE RETRIEVED AND WAS LEFT IN THE PATIENT. SURGERY AND PATIENT OUTCOME WERE NOT REPORTED. THIS REPORT IS FOR ONE (1) SHAFT F/AWL F/04.630.135S. THIS IS REPORT 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    354960 SHAFT F/AWL F/04.630.135S AWL HWJ OBERDORF SYNTHES PRODUKTIONS GMBH 1502741 07611819588028

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention