BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SMALL HEXAGONAL SCREWDRIVER WITH HOLDING SLEEVE

    MDR report key: 8241782 · Received January 11, 2019

    Report

    Report Number
    2939274-2019-55801
    Event Type
    Malfunction
    Date Received
    January 11, 2019
    Report Date
    December 18, 2018
    Manufacturer
    WRIGHTS LANE SYNTHES USA PRODUCTS LLC
    Product Code
    HXX
    UDI-DI
    10886982188373
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    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. THE DATE RECEIVED BY MANUFACTURER FOR FOLLOW-UP 1 SHOULD BE JANUARY 30, 2019. 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. H3, H6: PART: 314.020; LOT: 2053152; MANUFACTURING SITE: BETTLACH; RELEASE TO WAREHOUSE DATE: 30. JAN. 2003. THE DEVICE HISTORY RECORD SHOWS THIS LOT WAS PROCESSED THROUGH THE NORMAL MANUFACTURING AND INSPECTION OPERATIONS WITH NO REWORK OR NONCONFORMITIES NOTED. THIS LOT MET ALL DIMENSIONAL, VISUAL AND PACKAGING CRITERIA AT THE TIME OF RELEASE WITH NO ISSUES DOCUMENTED DURING THE MANUFACTURING PROCESS. ONLY TOP LEVEL DHR AVAILABLE FOR REVIEW AS COMPONENTS ARE NOT LOT TRACED THEREFORE A MATERIAL REVIEW FOR THE HANDLE COULD NOT BE PERFORMED. REVIEW OF THE DEVICE HISTORY RECORD SHOWED THAT THERE WERE NO ISSUES DURING THE MANUFACTURE OF THIS PRODUCT WHICH WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. CUSTOMER QUALITY INVESTIGATION: THE FOLLOWING INVESTIGATION FLOWS WERE PERFORMED: BROKEN & VISUAL (APPEARANCE NOT AS EXPECTED) VISUAL INSPECTION: VISUAL INSPECTION PERFORMED AT CUSTOMER QUALITY (CQ) OBSERVED THAT THE HEX TIP PORTION WAS OBSERVED TO BE SLIGHTLY WORN/STRIPPED. ADDITIONALLY, A CHUNK OF A PROXIMAL CORNER OF THE HANDLE HAS BROKEN OFF. THE HOLDING SLEEVE COMPONENT WAS NOT RETURNED. THE DEVICE CONDITION AGREES WITH THE COMPLAINT DESCRIPTION WITH TWO ADDITIONAL ISSUES IDENTIFIED DURING THIS INVESTIGATION. THEREFORE, THE COMPLAINT CONDITION WAS CONFIRMED. DEVICE HISTORY RECORD (DHR) REVIEW: THE RETURNED DEVICE WAS MANUFACTURED IN JANUARY 2003 AND IS APPROXIMATELY 16 YEARS OLD. THE DEVICE HISTORY RECORD SHOWS THIS LOT WAS PROCESSED THROUGH THE NORMAL MANUFACTURING AND INSPECTION OPERATIONS WITH NO REWORK OR NONCONFORMITIES NOTED. THIS LOT MET ALL DIMENSIONAL, VISUAL AND PACKAGING CRITERIA AT THE TIME OF RELEASE WITH NO ISSUES DOCUMENTED DURING THE MANUFACTURING PROCESS. ONLY TOP LEVEL DHR AVAILABLE FOR REVIEW AS COMPONENTS ARE NOT LOT TRACED THEREFORE A MATERIAL REVIEW FOR THE HANDLE COULD NOT BE PERFORMED. REVIEW OF THE DEVICE HISTORY RECORD SHOWED THAT THERE WERE NO ISSUES DURING THE MANUFACTURE OF THIS PRODUCT WHICH WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. DOCUMENT/SPECIFICATION REVIEW: RELEVANT DRAWINGS FOR THE RETURNED INSTRUMENT WERE REVIEWED (BOTH FROM THE TIME OF MANUFACTURE AND CURRENT REVISION). THE SMALL HEXAGONAL SCREWDRIVER WITH HOLDING SLEEVE IS A COMMON REUSABLE TRAUMA INSTRUMENT, NOTED IN APPROXIMATELY THIRTY-FOUR (34) SYSTEM TECHNIQUE GUIDES INCLUDING: SMALL FRAGMENT, 2.7MM/3.5MM VARIABLE ANGLE (VA) LOCKING COMPRESSION PLATE (LCP) ELBOW AND STANDARD TIBIAL PLATEAU LEVELING OSTEOTOMY. IN EACH SYSTEM, THE DRIVER IS UTILIZED TO INSERT SCREWS WITH 2.5MM HEXAGONAL RECESSES. NO PRODUCT DESIGN ISSUES OR DISCREPANCIES WERE OBSERVED DURING THIS INVESTIGATION. DIMENSIONAL INSPECTION: A DIMENSIONAL ANALYSIS WAS NOT PERFORMED ON THE HANDLE AS IT IS OBVIOUS THAT THE BROKEN OFF PORTION IS DUE TO POST MANUFACTURE WEAR. DIMENSIONAL INSPECTION PERFORMED ON THE SHAFT HEX TIP MEASURED FLAT TO FLAT DIMENSIONS OF 2.49MM WHICH FALLS WITHIN THE SPECIFICATION OF 2.5 MM -0.006/-0.03. MATERIAL ANALYSIS: THE HANDLE WAS SPECIFIED TO BE MANUFACTURED FROM PHENOLIC LE GRADE LINEN MATERIAL. ONLY TOP LEVEL DHR AVAILABLE FOR REVIEW AS COMPONENTS ARE NOT LOT TRACED THEREFORE A MATERIAL REVIEW FOR THE HANDLE FROM THE TIME OF MANUFACTURE COULD NOT BE PERFORMED. CONCLUSION: WHILE NO DEFINITIVE ROOT CAUSE COULD BE DETERMINED, IT IS POSSIBLE THAT THE GIVEN AGE OF DEVICE (16 YEARS) WITH CONSISTENT STERILE PROCESSING COULD HAVE LED TO THE WORN TIP AND BROKEN HANDLE CONDITIONS. THIS COMPLAINT IS CONFIRMED HOWEVER, NO PRODUCT DESIGN ISSUES OR MANUFACTURING DISCREPANCIES THAT WOULD CONTRIBUTE TO THE REPORTED COMPLAINT CONDITION WERE IDENTIFIED DURING THIS INVESTIGATION. NO NEW, UNIQUE OR DIFFERENT PATIENT HARMS WERE IDENTIFIED AS A RESULT OF THIS EVALUATION. ADDITIONAL MONITORING FOR ANY POTENTIAL SAFETY SIGNALS WILL BE CONDUCTED THROUGH COMPLAINT TRENDING AND OTHER POST MARKET SAFETY SURVEILLANCE ACTIVITIES. 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 · 1

    A REVIEW OF THE DEVICE HISTORY RECORDS HAS BEEN REQUESTED. THE DEVICE HAS BEEN RECEIVED, THE INVESTIGATION IS IN PROGRESS, NO CONCLUSION COULD BE DRAWN AT THE TIME OF FILING 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.

    Description of Event or Problem · 1

    IT WAS REPORTED ON UNKNOWN DATE, WHILE INSPECTING THE INSTRUMENTS AND THE TRAYS AFTER COMING OUT OF THE DECONTAMINATION PROCESS, THE SALES CONSULTANT NOTICED THAT THERE SOME PROBLEMS WITH THE FOLLOWING DEVICES: THE SMALL HEXAGON SCREWDRIVER WITH HOLDING SLEEVE TIP IS WORN AND STRIPPED, EXTRACTION SCREW TREADS FOR FEMORAL AND TIBIAL NAIL IS STRIPPED AND THE THREADS ARE COMPRESSED ON EACH OTHER. THERE IS NO PATIENT INVOLVEMENT WITH ANY OF THIS ITEM. THIS REPORT IS FOR ONE (1) SMALL HEXAGONAL SCREWDRIVER WITH HOLDING SLEEVE. THIS IS REPORT 1 OF 2 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    32372 SMALL HEXAGONAL SCREWDRIVER WITH HOLDING SLEEVE SCREWDRIVERS HXX WRIGHTS LANE SYNTHES USA PRODUCTS LLC 2053152 10886982188373

    Patients

    Seq Age Sex Outcome Treatment
    1