BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DHS®/DCS® GUIDE SHAFT

    MDR report key: 7351416 · Received March 19, 2018

    Report

    Report Number
    2939274-2018-51103
    Event Type
    Malfunction
    Date Received
    March 19, 2018
    Date of Event
    February 19, 2018
    Report Date
    February 19, 2018
    Manufacturer
    WRIGHTS LANE SYNTHES USA PRODUCTS LLC
    Product Code
    FZX
    UDI-DI
    10886982193247
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    HEALTH 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. A PRODUCT DEVELOPMENT INVESTIGATION WAS PERFORMED FOR THE SUBJECT DEVICE: DEVICE CONDITION: THE DHS/DCS GUIDE SHAFT, 338.21, WAS RECEIVED WITH A SLIGHT OFF AXIS BEND. THE ORIGIN OF THE BEND IS LOCATED APPROXIMATELY 25MM FROM THE DISTAL END OF THE DEVICE (CALIPERS: CA102P). THE DEVICE WAS FUNCTIONALLY TESTED WITH THE RETURNED MATING COUPLING SCREW. THE DEVICES WERE FOUND TO ASSEMBLE AND DISASSEMBLE BUT ADDITIONAL RESISTANCE WAS ENCOUNTERED DURING ASSEMBLED AND DISASSEMBLY DUE TO THE BENT CONDITION. THE PROXIMAL END OF THE SHAFT ALSO SHOWS SCRAPING CONSISTENT WITH HAVING BEEN GRIPPED WITH ANOTHER TOOL. THE BALANCE OF THE DEVICE SHOWS SURFACE WEAR CONSISTENT WITH USE AND WHICH WOULD NOT IMPACT THE FUNCTIONALITY. THUS, THE COMPLAINT CONDITION IS CONFIRMED AND CONSISTENT WITH THE REPORTED CONDITION. REPLICATION OF THE COMPLAINT CONDITION IS NOT APPLICABLE AS THE DEVICE IS ALREADY BENT. LOT NUMBER REVIEW: 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. THE LOT WENT THROUGH THE REQUIRED STEPS DURING THE INSPECTION AT THE TIME OF MANUFACTURING AND THE DHR RECORDS SHOWED NO ISSUES CONCERNING THE MATERIAL OR MATERIAL CONDITIONING. RELEASE TO WAREHOUSE DATE: 24.SEP.2003. DRAWING REVIEW: THE FOLLOWING DRAWINGS, REFLECTING THE CURRENT AND MANUFACTURED REVISION, WERE REVIEWED; DHS/DCS GUIDE SHAFT. THE OUTER DIAMETER OF THE SHAFT ON EACH SIDE OF THE BEND WAS INSPECTED. THE DEVICE DIAMETER MEASURED 7.04MM/7.00MM WHICH IS WITHIN THE SPECIFICATION OF 7.05MM +/-0.05 PER DRAWING. THE INNER DIAMETER OF THE SHAFT ON THE DISTAL END WAS FOUND TO MEASURE 5.13MM WHICH IS WITHIN THE SPECIFICATION OF 5.1MM +/-0.05 PER DRAWING. DURING THE INVESTIGATION NO PRODUCT DESIGN ISSUES OR DISCREPANCIES WERE OBSERVED THAT MAY HAVE CONTRIBUTED TO THE COMPLAINT CONDITION. NO DEFINITIVE ROOT CAUSE WAS ABLE TO BE DETERMINED AS CIRCUMSTANCES SURROUNDING THE EVENT AND THE SUBSEQUENT ISSUES DURING DISASSEMBLY, DOCUMENTED IN (B)(4), ARE UNKNOWN. HOWEVER, THE RETURNED CONDITION IS CONSISTENT WITH AN APPLICATION OF EXCEEDING OFF-AXIS FORCE. CONCLUSION: THE COMPLAINT CONDITION IS CONFIRMED AS THE GUIDE SHAFT WAS RECEIVED WITH A SLIGHT OFF AXIS BEND. A DEVICE HISTORY RECORD (DHR) REVIEW, DEVICE INSPECTION, FUNCTIONAL TEST, AND DRAWING REVIEW WERE PERFORMED AS PART OF THIS INVESTIGATION. THERE WERE NO ISSUES DURING THE MANUFACTURE OF THE PRODUCT THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION AND NO PRODUCT DESIGN ISSUES OR DISCREPANCIES WERE OBSERVED THAT MAY HAVE CONTRIBUTED TO THE COMPLAINT CONDITION. NO NEW MALFUNCTIONS WERE OBSERVED DURING THE COURSE OF THIS INVESTIGATION. 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

    ADDITIONAL NARRATIVE: DATE RETURNED TO MANUFACTURER. SUBJECT DEVICE HAS BEEN RECEIVED AND IS CURRENTLY IN THE EVALUATION PROCESS. 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

    THIS IS REPORT 1 OF 4 FOR (B)(4).

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. PATIENT WEIGHT IS NOT PROVIDED 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. DEVICE HISTORY RECORDS REVIEW WAS CONDUCTED. THE REPORT INDICATES THAT THE: PART NO.: 338.210, LOT NO.: 1203360, PART # 338.21, LOT # 4683918, SERIAL/SUPPLIER LOT # 1203360, MANUFACTURING LOCATION: (B)(4), RELEASE TO WAREHOUSE DATE: 24.SEP.2003. NO 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. NO 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. 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

    IT WAS REPORTED THAT AN INITIAL SURGERY FOR IMPLANTATION OF A DYNAMIC HIP SYSTEM (DHS) INTO THE PROXIMAL FEMUR WAS PERFORMED ON (B)(6) 2018. DURING THE SURGERY, THE LAG SCREW FOR THE DHS PLATE WAS PUT IN CORRECTLY, HOWEVER, THE PLATE WAS PUT IN OFF-AXIS. THEREFORE, THE PLATE HAD TO BE RE-POSITIONED, AND AS THE SURGEON WAS REMOVING THE CONNECTING SCREW AND GUIDE SHAFT FROM THE LAG SCREW, THE TWO INSTRUMENTS BECAME BENT (IT WAS REPORTED THAT THE SURGEON DID NOT DISCONNECT THE INSTRUMENTS PRIOR TO TAKING THEM OUT) AND THE SURGEON HAD TO USE PLIERS TO TAKE THE INSTRUMENTS OUT. THE SAME PLATE WAS PUT BACK INTO THE PATIENT WITHOUT ISSUE. A GUIDE WIRE WAS ALSO REPORTED TO BE BENT DURING THE SURGERY. THE PATIENT WAS IMPLANTED WITH A LAG SCREW, PLATE AND THREE 4.5 MM CORTICAL SCREWS (SIZE 36, 42 AND 48 MM). THERE WAS NO REPORTED DELAY AND THE SURGERY WAS COMPLETED SUCCESSFULLY. IT WAS FURTHER REPORTED THAT IN STERILE PROCESSING THE CONNECTING SCREW BROKE INTO TWO (2) PIECES AND THE GUIDE SHAFT, STILL IN ONE PIECE, WAS BENT TRYING TO GET THEM APART. THIS COMPLAINT IS LINKED WITH (B)(4) FOR THE POST-OPERATIVE EVENT OF BROKEN/BENT (CONNECTING SCREW AND GUIDE SHAFT) INSTRUMENTS. CONCOMITANT DEVICES REPORTED: DHS/DCS LAG SCREW 12.7 MM THREAD/90 MM (PART # 280.900, LOT # UNKNOWN, QUANTITY # 1), 4.5 MM CORTEX SCREW (PART # UNKNOWN, LOT # UNKNOWN, QUANTITY # 3). THIS COMPLAINT INVOLVES THREE (3) DEVICES. THIS REPORT IS 1 OF 3 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    192085 DHS®/DCS® GUIDE SHAFT GUIDE FZX WRIGHTS LANE SYNTHES USA PRODUCTS LLC 4683918 10886982193247

    Patients

    Seq Age Sex Outcome Treatment
    1 18 YR