BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    2.7MM/3.5MM VA-LCP LAT DSTL HUM PL 2H/LT/82MM MED-STER

    MDR report key: 9933369 · Received April 7, 2020

    Report

    Report Number
    8030965-2020-02682
    Event Type
    Malfunction
    Date Received
    April 7, 2020
    Date of Event
    March 7, 2020
    Report Date
    March 10, 2020
    Manufacturer
    OBERDORF SYNTHES PRODUKTIONS GMBH
    Product Code
    HRS
    UDI-DI
    07611819506114
    PMA / PMN Number
    K120070
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # (B)(4). DEPUY SYNTHESE IS SUBMITTING THIS REPORT PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH DEPUY SYNTHESE HAS NOT BEEN ABLE TO INVESTIGATE OR VERIFY PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY FDA, DEPUY SYNTHESE OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE DEVICE, DEPUY SYNTHESE, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. H10 ADDITIONAL NARRATIVE: D4: EXP. DATE H3, H4, H6: A REVIEW OF THE DEVICE HISTORY RECORD. DEVICE HISTORY LOT DEVICE HISTORY REVIEW DONE BY GABRIELLE TRUONG ON (B)(6) 2020. PART NUMBER: 02.117.902S LOT NUMBER: H863540 PART MANUFACTURE DATE: 18 APR 2019 MANUFACTURING LOCATION: ELMIRA PART EXPIRATION DATE: 01 APR 2029 NONCONFORMANCE NOTED: N/A DHR RECORD REVIEW: A REVIEW OF THE DEVICE HISTORY RECORD REVEALED NO COMPLAINT RELATED ANOMALIES. THE DEVICE HISTORY RECORD SHOWS THIS LOT OF 2.7MM/3.5MM VA-LCP LATERAL DISTAL PLATES WAS PROCESSED THROUGH THE NORMAL MANUFACTURING AND INSPECTION OPERATIONS WITH NO NON-CONFORMANCE'S OR REWORK NOTED. THE LOT QUANTITY OF 29 PIECES MET ALL DIMENSIONAL, VISUAL AND PACKAGING CRITERIA AT THE TIME OF RELEASE WITH NO ISSUES DOCUMENTED DURING THE MANUFACTURE THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. A REVIEW OF THE DEVICE HISTORY RECORD FOR THE RAW MATERIAL REVEALED NO COMPLAINT RELATED ANOMALIES. THE DEVICE HISTORY RECORD SHOWS THIS LOT MET ALL REQUIREMENTS AT THE TIME OF RELEASE WITH NO ISSUES DOCUMENTED DURING THE MANUFACTURE THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. DEVICE HISTORY BATCH NULL, DEVICE HISTORY REVIEW THE LOT QUANTITY OF 29 PIECES MET ALL DIMENSIONAL, VISUAL AND PACKAGING CRITERIA AT THE TIME OF RELEASE WITH NO ISSUES DOCUMENTED DURING THE MANUFACTURE THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. H3, H6: INVESTIGATION SUMMARY BACKGROUND: AN ELBOW FRACTURE. AFTER REDUCING AND INSERTING THE IMPLANTS ¿ AN INTER-OPERATIVE X-RAY WAS TAKEN ¿ THE PLATE LOOKS STRANGE. THE REMOVED THE IMPLANT A VISUAL INSPECTED IT. AND THE PLATE HAD A DEFORMITY ON IT. THE TOOK A NEW IMPLANT AND USE THAT TO TREAD THE PATIENT. CONCOMITANT DEVICE REPORTED: UNKNOWN SCREWS (PART # UNKNOWN, LOT # UNKNOWN, QUANTITY # UNKNOWN). THIS COMPLAINT INVOLVES ONE (1) DEVICE INVESTIGATION FLOW: DAMAGE VISUAL INSPECTION: THE VA-LCP DHP 2.7/3.5 LAT LE MED 2HO L82 SS (P/N: 02.117.902S, LOT #: H863540) WAS RETURNED AND RECEIVED AT US CQ. UPON VISUAL INSPECTION, THE DEVICE WAS OBSERVED TO BE BENT INWARDS. THERE WERE SCRATCHES ON THE DEVICE BUT HAVE NO IMPACT ON DEVICE FUNCTIONALITY. NO OTHER DEFECTS WERE IDENTIFIED WITH THE RETURNED DEVICE. DIMENSIONAL INSPECTION: THE DIMENSIONAL INSPECTION WAS PERFORMED ON THE RETURNED DEVICE NEAR THE BENT PORTION. THE WIDTH OF THE PLATE WAS MEASURED AND WITHIN THE SPECIFICATION. DOCUMENT/SPECIFICATION REVIEW BASED ON THE DATE OF MANUFACTURE, CURRENT AND MANUFACTURED REVISION OF DRAWINGS WERE REVIEWED THE DEVICE RECEIVED WAS BENT. HENCE CONFIRMING THE ALLEGATION. INVESTIGATION CONCLUSION THE COMPLAINT CONDITION IS CONFIRMED FOR THE VA-LCP DHP 2.7/3.5 LAT LE MED 2HO L82 SS (P/N: 02.117.902S, LOT #: H863540). THERE IS NO INDICATION THAT A DESIGN OR MANUFACTURING ISSUE HAS CAUSED THE ISSUE AND HENCE THE ROOT CAUSE CANNOT BE DETERMINED. THE POTENTIAL CAUSE COULD BE DUE TO UNINTENDED FORCES APPLIED TO THE DEVICE. BASED ON THE INVESTIGATION FINDINGS, IT HAS BEEN DETERMINED THAT NO CORRECTIVE AND/OR PREVENTATIVE ACTION IS PROPOSED. ADDITIONAL MONITORING FOR ANY POTENTIAL SAFETY SIGNALS WILL BE CONDUCTED THROUGH COMPLAINT TRENDING AND OTHER POST-MARKET SAFETY SURVEILLANCE ACTIVITIES. 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. 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

    (B)(4). ADDITIONAL PRO-CODE: HWC. DEVICE AVAILABLE FOR EVALUATION: DEVICE RETURNED. (B)(6). THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN AT THE TIME OF FILING THIS REPORT. A REVIEW OF THE DEVICE HISTORY RECORD 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.

    Description of Event or Problem · 1

    DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT A PATIENT HAS A ELBOW FRACTURE. IT WAS ALSO REPORTED THAT AFTER REDUCING AND INSERTING THE IMPLANTS, A INTRAOPERATIVE X-RAY WAS TAKEN ¿ THE PLATE LOOK STRANGE. THE IMPLANT WAS REMOVED AND VISUAL INSPECTED. IT WAS NOTICED THAT THE PLATE HAD A DEFORMITY ON IT. A NEW IMPLANT WAS USED TO COMPLETE THE SURGERY. SURGERY WAS DELAYED DUE TO THE REPORTED EVENT 30 MINUTES: CONCOMITANT DEVICE REPORTED: UNKNOWN SCREWS (PART # UNKNOWN, LOT # UNKNOWN, QUANTITY # UNKNOWN). THIS COMPLAINT INVOLVES ONE (1) DEVICE THIS REPORT IS 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    396691 2.7MM/3.5MM VA-LCP LAT DSTL HUM PL 2H/LT/82MM MED-STER PLATE, FIXATION, BONE HRS OBERDORF SYNTHES PRODUKTIONS GMBH H863540 07611819506114

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK - SCREWS: TRAUMA| VA-LCP DHP 2.7/3.5 LAT LE MED 2HO L82 SS| UNK - SCREWS: TRAUMA| VA-LCP DHP 2.7/3.5 LAT LE MED 2HO L82 SS