BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PROTECT SLEEVE 11.5/8.5 F/A2FN YELL

    MDR report key: 10092548 · Received May 27, 2020

    Report

    Report Number
    8030965-2020-03723
    Event Type
    Malfunction
    Date Received
    May 27, 2020
    Date of Event
    May 14, 2020
    Report Date
    May 14, 2020
    Manufacturer
    OBERDORF SYNTHES PRODUKTIONS GMBH
    Product Code
    LXH
    UDI-DI
    07611819326804
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MY
    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. H3, H4, H6: PART NUMBER: 03.010.353, SYNTHES LOT NUMBER: 9945946, MANUFACTURING SITE: HÄGENDORF, RELEASE TO WAREHOUSE DATE: AUGUST 12, 2016. VISUAL INSPECTION: THE DEVICE SHOWS SIGNS OF USE ALL OVER ON THE SURFACE. MOST OF THE MECHANICAL DAMAGES ARE LOCATED AT THE BOTTOM AS WELL AS AT THE TOP OF THE DEVICE. FURTHERMORE, DEFORMATION AT THE BORE WITH A COUNTERSINK WAS DETECTED. ALL DAMAGES ARE CLEARLY CAUSED POST MANUFACTURING CONSIDERING THE EVIDENCE THAT ANODIZED LAYER IS PARTIALLY DISAPPEARED. THE OBSERVED DAMAGE IS CONSISTENT WITH THE REPORTED COMPLAINT CONDITION AS SUCH THE COMPLAINT CONDITION CAN BE CONFIRMED. ALL FEATURES RELATED TO THE REPORTED COMPLAINT CONDITION WERE REVIEWED AND NO OTHER ISSUES WERE IDENTIFIED. CONCLUSION: THE COMPLAINT CONDITION IS CONFIRMED DUE TO THE DAMAGES FOUND ON THE DEVICE AND THE RECEIVED PICTURES ATTACHED ON COMPLAINT LEVEL. BASED ON THE POST MANUFACTURING DAMAGES, A INADEQUATE HANDLING, SUCH AS EXCESSIVE FORCE APPLICATION, HAS MAINLY AFFECTED THE EQUIPMENT'S PERFORMANCE. DUE TO THE DEFORMATION AT THE INNER BORE PROPER FUNCTIONALITY OF THE DEVICE WAS NOT POSSIBLE ANYMORE. IN ADDITION, CONSIDERING THAT THIS INSTRUMENT IS A MULTIPLE USE INSTRUMENT, A POOR CONDITION OF THE DEVICE BEFORE SURGERY MAY ALSO HAVE CONTRIBUTED TO THE REPORTED MALFUNCTION. BECAUSE OF THAT WE WOULD LIKE TO DRAW YOUR ATTENTION ON PAGE 7 IN THE LEAFLET ¿IMPORTANT INFORMATION¿ CHECK INSTRUMENTS FOR SOUND SURFACES, AND CORRECT ADJUSTMENT AND FUNCTION. DO NOT USE SEVERELY DAMAGED INSTRUMENTS, INSTRUMENTS WITH UNRECOGNIZABLE MARKINGS, CORROSION, OR BLUNT CUTTING SURFACES. DURING THE INVESTIGATION, NO PRODUCT DESIGN OR MANUFACTURING ISSUES WERE OBSERVED THAT MAY HAVE CONTRIBUTED TO THE COMPLAINT CONDITION; THEREFORE, FURTHER CORRECTIVE AND/OR PREVENTIVE ACTION IS NOT REQUIRED. ADDITIONAL MONITORING FOR ANY POTENTIAL SAFETY SIGNALS WILL BE CONDUCTED THROUGH COMPLAINT TRENDING AND OTHER POST MARKET SAFETY SURVEILLANCE ACTIVITIES. THE ROOT CAUSE WAS IDENTIFIED DURING THE PERFORMED CUSTOMER QUALITY (CQ) EVALUATION AND THEREFORE THE IN THE INVESTIGATION FLOW LISTED REMAINING INVESTIGATION STEPS ARE NOT REQUIRED. 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 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.

    Description of Event or Problem · 0

    CONCOMITANT DEVICES REPORTED: HIP SCREW (PART NUMBER UNKNOWN, LOT UNKNOWN, QUANTITY 1), JIG (PART NUMBER UNKNOWN, LOT UNKNOWN, QUANTITY 1), DEPTH GAUGE FOR LOCKING SCREWS TO 100MM FOR IM NAILS (PART NUMBER 03.010.072, LOT UNKNOWN, QUANTITY 1) DRILL SLEEVE 8.5/3.2 (PART NUMBER 03.010.354, LOT 9832091 QUANTITY 1).

    Additional Manufacturer Narrative · 1

    ADDITIONAL NARRATIVE: COMPLAINANT PART IS EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION BUT HAS YET TO BE RECEIVED. REPORTER IS A SYNTHES EMPLOYEE. WITHOUT A LOT NUMBER THE DEVICE HISTORY RECORDS REVIEW COULD NOT BE COMPLETED. PRODUCT WAS NOT RETURNED. BASED ON THE INFORMATION AVAILABLE, IT HAS BEEN DETERMINED THAT NO CORRECTIVE AND/OR PREVENTATIVE ACTION IS PROPOSED. THIS COMPLAINT WILL BE ACCOUNTED FOR AND MONITORED VIA POST MARKET SURVEILLANCE ACTIVITIES. IF ADDITIONAL INFORMATION IS MADE AVAILABLE, THE INVESTIGATION WILL BE UPDATED AS APPLICABLE. DEVICE IS NOT DISTRIBUTED IN THE UNITED STATES, BUT IS SIMILAR TO DEVICE MARKETED IN THE USA. 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) 2020, DURING THE REMOVAL OF THE GOLDEN RECON SLEEVE, AFTER INSERTING THE 6.5 HIP SCREW, THE GOLDEN RECON SLEEVE WAS STUCK TOGETHER WITH THE HIP SCREW AND COULD NOT BE REMOVED FROM THE JIG. SURGEON STRUGGLED TO REMOVE BOTH THE GOLDEN SLEEVE AND HIP SCREW. THE HIP SCREW WAS BEING FORCED OUT BY TURNING ANTICLOCKWISE AND IT WAS NOTICED THAT THE END OF THE GOLDEN RECON SLEEVE WAS DISTORTED. THE DISTORTED SLEEVE CAUSED THE HEAD OF THE RECON HIP SCREW TO BECOME STUCK INSIDE THE SLEEVE, WHICH PREVENTED THE SLEEVE FROM COMING OUT THE JIG. ALSO, THE SURGEON FOUND THAT THE OUTER PART OF THE DEPTH GAUGE WAS HARD TO PUSH AND PULL, WHICH WAS POSSIBLY DUE TO DISTORTION. THERE WAS AN UNKNOWN SURGICAL DELAY REPORTED. NO FRAGMENTS WERE GENERATED. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. CONCOMITANT DEVICE REPORTED: NAIL HEAD ELEMENTS: HIP SCREW (PART NUMBER UNKNOWN, LOT UNKNOWN, QUANTITY 1), JIG (PART NUMBER UNKNOWN, LOT UNKNOWN, QUANTITY 1), JIG (PART NUMBER UNKNOWN, LOT UNKNOWN, QUANTITY 1), DEPTH GAUGE FOR LOCKING SCREWS TO 100MM FOR IM NAILS (PART NUMBER 03.010.072, LOT UNKNOWN, QUANTITY 1). THIS REPORT INVOLVES ONE (1) PROTECT SLEEVE 11.5/8.5 F/A2FN YELL. THIS IS REPORT 1 OF 2 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    555665 PROTECT SLEEVE 11.5/8.5 F/A2FN YELL MISC ORTHO SURGICAL INSTRUMENT LXH OBERDORF SYNTHES PRODUKTIONS GMBH 9945946 07611819326804

    Patients

    Seq Age Sex Outcome Treatment
    1 DEPTH GAUGE F/LOCK-SCR MEAS-RANGE-110 F/| DEPTH GAUGE F/LOCK-SCR MEAS-RANGE-110 F/| UNK - JIG| UNK - JIG| UNK - NAIL HEAD ELEMENTS: HIP SCREW| UNK - NAIL HEAD ELEMENTS: HIP SCREW| DEPTH GAUGE F/LOCK-SCR MEAS-RANGE-110 F/| UNK - JIG| UNK - NAIL HEAD ELEMENTS: HIP SCREW