BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SMALL HEXAGONAL SCREWDRIVER WITH HOLDING SLEEVE

    MDR report key: 7300624 · Received February 27, 2018

    Report

    Report Number
    2939274-2018-50802
    Event Type
    Malfunction
    Date Received
    February 27, 2018
    Date of Event
    January 22, 2018
    Report Date
    January 25, 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, 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. : DHR REVIEW WAS COMPLETED. PART NO.: 314.020 , LOT NO.: 2082995 , MANUFACTURING LOCATION: BETTLACH , RELEASE TO WAREHOUSE DATE: 16.JAN.2004 . 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. CUSTOMER QUALITY CONDUCTED AN INVESTIGATION OF THE RETURNED DEVICE. DEVICE CONDITION: THE DEVICE (PART 314.020, LOT 2082995, MFG 16.JAN.2004) WAS FORWARDED FROM SERVICE AND REPAIR WHEN IT WAS DEEMED UNREPAIRABLE. AT US CQ THE DOWEL PIN WAS NOTED TO BE BACKING OUT DUE TO BEING BROKEN, AND THE SHAFT ABLE TO ROTATE SLIGHTLY WITHIN THE PHENOLIC HANDLE, THERE WERE SMALL CRACKS IN THE PHENOLIC. THE DISTAL TIP WAS WORN AND ROUNDED. THE COMPLAINT CONDITION WAS VISUALLY CONFIRMED AND CONSISTENT WITH THE REPORTED CONDITION. REPLICATION OF THE COMPLAINT CONDITION IS NOT APPLICABLE AS THE DEVICES WERE RETURNED BROKEN. LOT NUMBER REVIEW: DHR REVIEW SHOWED NO NCR¿S WERE GENERATED DURING PRODUCTION. THE MATERIAL, AND MATERIAL PROPERTIES OF THE RETURNED PART WERE DETERMINED TO BE CONFORMING AT THE TIME OF MANUFACTURE BASED ON REVIEW OF THE DHR(S). DRAWING REVIEW: THE DRAWING WAS REVIEWED; DIMENSIONAL ANALYSIS WAS COMPLETED, DIAMETER OF DOWEL PIN, MEASURED 2.01 MM ON BOTH SIDES. THIS IS WITHIN SPECIFICATION OF 1.97 TO 2.01 MM, BASED ON DRAWING. DURING THE INVESTIGATION NO PRODUCT DESIGN ISSUES OR DISCREPANCIES WERE OBSERVED THAT MAY HAVE CONTRIBUTED TO THE COMPLAINT CONDITION. CONCLUSION: THE COMPLAINT CONDITION IS CONFIRMED AS THE DRIVER (PART 314.020, LOT 2082995) WAS RECEIVED BROKEN. A DEVICE INSPECTION, DEVICE HISTORY RECORD REVIEW, DIMENSIONAL ANALYSIS AND DRAWING REVIEW WERE PERFORMED AS PART OF THIS INVESTIGATION. THERE IS NO INDICATION THAT A DESIGN OR MANUFACTURING ISSUE CONTRIBUTED TO THE COMPLAINT. WHILE NO DEFINITIVE ROOT CAUSE COULD BE DETERMINED IT LIKELY THAT OVER THE COURSE OF 13+ YEARS IN THE FIELD THE DEVICE EXPERIENCED UNINTENDED FORCES (SUCH AS BEING DROPPED OR DAMAGED DURING REPEATED STERILE PROCESSING). 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.

    Description of Event or Problem · 0

    CONCOMITANT DEVICE REPORTED: HOLDING SLEEVE (314.060, LOT 2065, QUANTITY 1).

    Additional Manufacturer Narrative · 1

    DEVICE IS A VETERINARY PRODUCT. NO PATIENT INFORMATION WILL BE REPORTED. DEVICE IS AN INSTRUMENT AND IS NOT IMPLANTED/EXPLANTED. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. 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 AN INITIAL TIBIAL PLATEAU LEVELING OSTEOTOMY SURGERY ON A CANINE PERFORMED ON (B)(6) 2018, THERE WAS A CRACKING SOUND FROM THE SMALL HEXAGONAL SCREWDRIVER WITH HOLDING SLEEVE WHILE LIFTING THE NAIL OF THE DEVICE. THE SURGEON THEN PUT THE DEVICE ASIDE, AND FINISHED UP THE SURGERY WITH ANOTHER DEVICE ALREADY ON HAND. THE SURGERY WAS COMPLETED SUCCESSFULLY WITH NO SURGICAL DELAY AND NO PATIENT HARM. DURING SERVICE EVALUATION OF THE RETURNED SUBJECT DEVICE, IT WAS IDENTIFIED THAT THE HANDLE WAS CRACKED AT THE PIN, AND THE SCREWDRIVER TIP WAS WORN. THIS CONDITION WAS RE-EVALUATED AND WAS DETERMINED AS REPORTABLE ON (B)(6) 2018. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    142531 SMALL HEXAGONAL SCREWDRIVER WITH HOLDING SLEEVE SCREWDRIVERS HXX WRIGHTS LANE SYNTHES USA PRODUCTS LLC 2082995 10886982188373

    Patients

    Seq Age Sex Outcome Treatment
    1