BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EXTRACTSCR F/PFNA BLADE

    MDR report key: 7224675 · Received January 29, 2018

    Report

    Report Number
    8030965-2018-50648
    Event Type
    Malfunction
    Date Received
    January 29, 2018
    Date of Event
    December 2, 2017
    Report Date
    January 7, 2018
    Manufacturer
    OBERDORF : SYNTHES PRODUKTIONS GMBH
    Product Code
    HWB
    UDI-DI
    07611819349483
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NZ
    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

    A DEVICE HISTORY RECORD (DHR) REVIEW WAS PERFORMED FOR PART NO.: 03.010.411, LOT NO.: 8890043: MANUFACTURING LOCATION: BETTLACH, RELEASE TO WAREHOUSE DATE: 07.MAY.2014: NO NON-CONFORMANCE REPORTS (NCRS) WERE GENERATED DURING PRODUCTION. REVIEW OF THE DEVICE HISTORY RECORD(S) SHOWED THAT THERE WERE NO ISSUES DURING THE MANUFACTURE OF THE PRODUCT THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. A PRODUCT INVESTIGATION WAS PERFORMED. DEVICE WAS RECEIVED FOR INVESTIGATION. UPON VISUAL INSPECTION OF THE COMPLAINT DEVICE IT CAN BE SEEN THAT TIP (AT THE THREAT SECTION) IS BROKEN OFF, THIS THUS CONFIRMING THE COMPLAINT DESCRIPTION. FURTHERMORE, THE ARTICLE HAS SIGNS ALL OVER THE SURFACE. DURING INVESTIGATION THE DIAMETER AND DIAMETER WAS MEASURED PER RELEVANT DRAWING, THE MEASURE RESULT IS WITHIN ACCURACY. FURTHERMORE, THE COMPLAINT RELEVANT DIMENSIONS CANNOT BE CHECKED FOR DIMENSIONAL ACCURACY, BECAUSE OF THE DAMAGE. BASED TO THE MENTIONED FINDINGS, NO FURTHER INVESTIGATION WILL BE DONE FOR RAW MATERIAL AND HARDNESS. UNFORTUNATELY, WE ARE NOT ABLE TO DETERMINE THE EXACT REASON FOR THIS OCCURRENCE, BUT WE HAVE TO ASSUME THAT DURING THE OPERATION AN APPLICATION ERROR MAY HAVE TAKEN PLACE. TO PREVENT SUCH PROBLEMS, IT IS NECESSARY WORN OR DAMAGED INSTRUMENTS TO REPLACE AND/OR TO OPERATE ACCORDING TO THE TECHNIQUE GUIDE ¿NOTE: IF THE REMOVAL OF THE PFNA/PFNA-II BLADE IS NOT POSSIBLE WITH THE STANDARD INSTRUMENTS USE THE SPECIAL INSTRUMENTS FROM THE PNFA/PFNA-II BLADE EXTRACTION SET AND THE CORRESPONDING SURGICAL TECHNIQUE. 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

    INITIAL REPORTER TELEPHONE: (B)(6), 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

    ADDITIONAL NARRATIVE: DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. PATIENT INFORMATION NOT AVAILABLE FOR REPORTING. DEVICE IS AN INSTRUMENT AND IS NOT IMPLANTED/EXPLANTED. COMPLAINANT PART IS EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION, BUT HAS YET TO BE RECEIVED. REPORTER LAST NAME AND PHONE NUMBER NOT AVAILABLE FOR REPORTING. DEVICE IS NOT DISTRIBUTED IN THE UNITED STATES, BUT IS SIMILAR TO DEVICE MARKETED IN THE USA. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. 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 DURING AN INITIAL PROXIMAL FEMORAL NAIL ANTIROTATION (PFNA) PROCEDURE ON (B)(6) 2017 THE PFNA EXTRACTION SCREW BROKE INTRAOPERATIVELY. THE SURGEON HAD DIFFICULTY INSERTING THE ORIGINAL BLADE. THE ORIGINAL BLADE WAS REMOVED AND A NEW BLADE WAS INSERTED. THE SCREW BROKE IN THE PROCESS OF REMOVING THE BLADE. SURGICAL DELAY IS UNKNOWN AND WAS NOT REPORTED. PATIENT STATUS IS UNKNOWN. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    69722 EXTRACTSCR F/PFNA BLADE EXTRACTOR HWB OBERDORF : SYNTHES PRODUKTIONS GMBH 8890043 07611819349483

    Patients

    Seq Age Sex Outcome Treatment
    1