BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SMALL HEXAGONAL SCREWDRIVER WITH HOLDING SLEEVE

    MDR report key: 7666104 · Received July 6, 2018

    Report

    Report Number
    2939274-2018-52731
    Event Type
    Malfunction
    Date Received
    July 6, 2018
    Report Date
    July 5, 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
    CA
    Reporter Occupation
    PHYSICIAN ASSISTANT

    Narratives

    Additional Manufacturer Narrative · 1

    REPORTEDLY THERE WAS NO PATIENT INVOLVEMENT. DATE OF EVENT IS UNKNOWN. DEVICE IS AN INSTRUMENT AND IS NOT IMPLANTED/EXPLANTED. A DEVICE HISTORY RECORD REVIEW WAS PERFORMED FOR THE SUBJECT DEVICE: PART: 314.020; LOT: 2053152; MANUFACTURING SITE: (B)(4); RELEASE TO WAREHOUSE DATE: 30. JAN. 2003. THE DEVICE HISTORY RECORD SHOWS THIS LOT OF (B)(4) PIECES 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. 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. A PRODUCT DEVELOPMENT INVESTIGATION WAS PERFORMED FOR THE SUBJECT DEVICE: CUSTOMER QUALITY INVESTIGATION: THE FOLLOWING INVESTIGATIONS WERE PERFORMED: DAMAGE VISUAL (APPEARANCE NOT AS EXPECTED): VISUAL INSPECTION PERFORMED AT CUSTOMER QUALITY OBSERVED MINOR CRACKING AT THE HANDLE PORTIONS UNDER 10X MAGNIFICATION. ADDITIONALLY, THE HEX TIP PORTION WAS OBSERVED TO BE SLIGHTLY WORN AND BENT. THEREFORE, OVER ALL COMPLAINT CONDITION IS CONFIRMED. THE COMPLAINT CONDITION AGREE WITH THE COMPLAINT DESCRIPTION. THEREFORE, THE COMPLAINT CONDITION WAS CONFIRMED. THE COMPLAINT CONDITION DOES NOT AGREE WITH THE COMPLAINT DESCRIPTION. HOWEVER NEW ISSUES WERE IDENTIFIED. THEREFORE, THE OVERALL COMPLAINT CONDITION WAS CONFIRMED. RELEVANT DRAWINGS FOR THE RETURNED INSTRUMENT WERE REVIEWED (BOTH FROM THE TIME OF MANUFACTURE AND CURRENT REVISION): TOP-LEVEL (314_02 ), SHAFT DRAWING 314_02_1 AND HANDLE (E2002). THE DESIGN, MATERIALS AND FINISHING PROCESSES WERE FOUND TO BE APPROPRIATE FOR THE INTENDED USE OF THESE DEVICES. NO DIMENSIONAL ANALYSIS CAN BE COMPLETED DUE TO POST-MANUFACTURING DAMAGE. THE DIMENSIONAL ANALYSIS WAS NOT PERFORMED ON THE HANDLE AS IT IS OBVIOUS THAT THE MINOR CRACKED PORTIONS ARE DUE TO POST MANUFACTURE WEAR. DIMENSIONAL INSPECTION PERFORMED ON THE SHAFT HEX TIP DIMENSIONS MEASURED CORNER TO CORNER DIMENSIONS AS 2.82 MM (CA-814) THAT FALLS WITHIN THE SPECIFICATION OF 2.79 MM TO 2.83 MM PER 314_02_1. DHR REVIEW PERFORMED ON THE GIVEN DEVICE LOT NUMBER SHOWED THAT THERE WERE NO ISSUES DURING THE MANUFACTURE OF THIS PRODUCT, AND ANY SUBCOMPONENTS, WHICH WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. WHILE NO DEFINITIVE ROOT CAUSE COULD BE DETERMINED IT IS POSSIBLE THAT WITH THE GIVEN AGE OF DEVICE (OVER 15 YEARS) WITH CONSISTENT STERILE PROCESSING COULD HAVE LED TO WORN TIP AND CRACKED HANDLE CONDITIONS. DURING THE INVESTIGATION, NO PRODUCT DESIGN ISSUES OR DISCREPANCIES WERE OBSERVED THAT MAY HAVE CONTRIBUTED TO THE COMPLAINT CONDITION. 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING STERILE PROCESSING WEAR/TEAR ON THE HANDLE OF A SMALL HEXAGONAL SCREWDRIVER WAS DISCOVERED. IT APPEARS THE WOOD-LIKE HANDLE IS CRACKING. THERE WAS NO SURGERY OR PATIENT INVOLVEMENT. THIS IS REPORT 2 OF 2 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    507759 SMALL HEXAGONAL SCREWDRIVER WITH HOLDING SLEEVE SCREWDRIVERS HXX WRIGHTS LANE SYNTHES USA PRODUCTS LLC 2053152 10886982188373

    Patients

    Seq Age Sex Outcome Treatment
    1