BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DEPTH GAUGE FOR LOCKING SCREWS TO 100MM FOR IM NAILS

    MDR report key: 10092559 · Received May 27, 2020

    Report

    Report Number
    8030965-2020-03724
    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
    HTJ
    UDI-DI
    07611819760943
    PMA / PMN Number
    EXEMPT
    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:03.010.072, LOT:8110423, MANUFACTURING SITE:HÄGENDORF, RELEASE TO WAREHOUSE DATE: NOVEMBER 9, 2012. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE LOT NUMBER, AND NO NON-CONFORMANCES WERE IDENTIFIED. VISUAL INSPECTION: THE RETURNED INSTRUMENT IS IN A VERY USED CONDITION. THE SLIDING MECHANISM IS ROUGH-RUNNING AND THE TIP WAS FOUND SLIGHTLY BENT. THE OBSERVED DAMAGE IS CONSISTENT WITH THE REPORTED COMPLAINT CONDITION AS SUCH THE COMPLAINT CONDITION CAN BE CONFIRMED. FURTHERMORE THE ANODIZED SURFACE IS FADED AWAY. ALL FEATURES RELATED TO THE REPORTED COMPLAINT CONDITION WERE REVIEWED AND NO OTHER ISSUES WERE IDENTIFIED. FUNCTIONAL TEST THE RETURNED DEPTH GAUGE WAS TESTED AND THE COMPLAINT CONDITION COULD BE CONFIRMED, AS IT IS ROUGH RUNNING AS REPORTED. THE INSTRUMENT WAS LUBRICATED WITH SYNTHES SPECIAL OIL DURING THE INVESTIGATION AND WAS THEN FREELY MOVABLE AS REQUIRED. DIMENSIONAL INSPECTION: A DIMENSIONAL TEST IS NOT APPROPRIATE, SINCE ALL COMPLAINT-RELEVANT DIMENSIONS CAN NO LONGER CORRESPOND TO THE VALID TECHNICAL DRAWINGS SPECIFICATIONS DUE TO THE DAMAGE INCURRED. DOCUMENT/ SPECIFICATION REVIEW: THE MANUFACTURING REVIEW SHOWS THAT THE PRODUCTION PROCEDURE WAS ACCORDING TO THE SPECIFICATIONS AND THERE WERE NO ISSUES THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. AS INDICATED IN THE MANUFACTURING DOCUMENTS, THE INSTRUMENT WAS INSPECTED TO 100% BEFORE THE PART LEFT MANUFACTURING SITE, SEE ALSO INSPECTION SHEET. THE DEFORMATION ISSUE IS CLEARLY CAUSED POST MANUFACTURING. SUMMARY: THE RECEIVED CONDITION OF THE DEVICE IS CONCORDANT WITH THE COMPLAINT DESCRIPTION AND THE COMPLAINT CONDITION IS CONFIRMED. BECAUSE OF THE DAMAGE, IT IS NOT POSSIBLE TO MEASURE THE RELEVANT DIMENSIONS ANYMORE. HOWEVER, BASED ON THE FINDINGS ABOVE NO FAULT COULD BE FOUND IN MATERIAL OR DURING THE PRODUCTION. THIS LOT OF 36 PIECES WAS MANUFACTURED IN NOVEMBER 2012 AND WE ARE NOT AWARE OF ANY OTHER COMPLAINT FOR THIS PART- AND LOT NUMBER COMBINATION. THE DEFORMATION ISSUE IS TYPICALLY CONSISTENT WITH INADEQUATE HANDLING OF THE DEVICE IN COMBINATION WITH EXCESSIVE FORCE APPLICATION. REGARDING THE ROUGH-RUNNING ISSUE, INCORRECTLY MAINTENANCE OF THE DEVICE, IS THE MAINLY CAUSE OF THE MALFUNCTION AS THE DEVICE WAS FULLY FUNCTIONAL AFTER LUBRICATION AT CUSTOMER QUALITY ZUCHWIL. FOR SUCH ISSUES PLEASE TAKE NOTICE ON PAGE 14 IN THE LEAFLET ¿IMPORTANT INFORMATION¿ MOVING INSTRUMENT PARTS, E.G. JOINTS, SLIDING PARTS, DISMOUNTABLE THREADED CONNECTIONS ETC. MUST BE REGULARLY LUBRICATED. 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. 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.

    Description of Event or Problem · 0

    CONCOMITANT DEVICE REPORTED: HIP SCREW (PART NUMBER UNKNOWN, LOT UNKNOWN, QUANTITY 1), JIG (PART NUMBER UNKNOWN, LOT UNKNOWN, QUANTITY 1) PROTECT SLEEVE 11.5/8.5 F/A2FN YELL (PART NUMBER 03.010.353, LOT 9945946, 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. (B)(6). 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 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), PROTECT SLEEVE 11.5/8.5 F/A2FN YELL (PART NUMBER 03.010.353, LOT UNKNOWN, QUANTITY 1). THIS REPORT INVOLVES ONE (1) DEPTH GAUGE FOR LOCKING SCREWS TO 100MM FOR IM NAILS. THIS IS REPORT 2 OF 2 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    555909 DEPTH GAUGE FOR LOCKING SCREWS TO 100MM FOR IM NAILS GAUGE,DEPTH HTJ OBERDORF SYNTHES PRODUKTIONS GMBH 8110423 07611819760943

    Patients

    Seq Age Sex Outcome Treatment
    1 PROTECT SLEEVE 11.5/8.5 F/A2FN YELL| UNK - JIG| UNK - NAIL HEAD ELEMENTS: HIP SCREW| PROTECT SLEEVE 11.5/8.5 F/A2FN YELL| UNK - JIG| UNK - NAIL HEAD ELEMENTS: HIP SCREW