BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    STARDRIVE SCRWDRVR SHFT/T4 50MM/SELF-RETAINING/HXC

    MDR report key: 8653933 · Received May 30, 2019

    Report

    Report Number
    2939274-2019-58373
    Event Type
    Malfunction
    Date Received
    May 30, 2019
    Date of Event
    April 30, 2019
    Report Date
    April 30, 2019
    Manufacturer
    WRIGHTS LANE SYNTHES USA PRODUCTS LLC
    Product Code
    HXX
    UDI-DI
    10886982075192
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    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. DEVICE HISTORY LOT: MANUFACTURING LOCATION: SUPPLIER- UNIVERSAL PUNCH / MONUMENT. MANUFACTURING DATE: 07-SEP-2016. PART NUMBER: 03.130.010, STARDRIVE SCRWDRVR SHFT/T4 50MM/SELF-RETAINING/HXC. LOT NUMBER: H082466 (NON-STERILE). LOT QUANTITY: 91. FOUR PIECES WERE SCRAPPED AT OP #60, VENDOR TIN COAT, FOR DESTRUCTIVE (HARDNESS) TESTING. ONE PIECE WAS SCRAPPED IN CELL AT OP #,70, INCOMING INSPECTION II, FOR UNACCEPTABLE SURFACE FINISH COSMETICS. WORK ORDER TRAVELER MET ALL INSPECTION ACCEPTANCE CRITERIA APART FROM THE FIVE PIECES NOTED. INSPECTION SHEET, INCOMING INSPECTION I, INCOMING INSPECTION II, INCOMING FINAL INSPECTION, MET ALL INSPECTION ACCEPTANCE CRITERIA APART FROM THE ONE PIECE NOTED FOR SURFACE FINISH. PACKAGING LABEL LOG WAS REVIEWED AND DETERMINED TO BE CONFORMING. CERTIFICATE OF COMPLIANCE RECEIVED FROM UNIVERSAL PUNCH FOR OP # 10 (VENDOR MACHINE) DATED 06-JUN-2016 WAS REVIEWED AND DETERMINED TO BE CONFORMING. INSPECTION CERTIFICATE SUPPLIED TO UNIVERSAL PUNCH FROM ZAPP (FOR RAW MATERIAL) DATED 04-SEP-2014 WAS REVIEWED AND DETERMINED TO BE CONFORMING. CERTIFICATE OF ANALYSIS SUPPLIED BY IONBOND FOR OP # 60 (TIN COAT) DATED 24-AUG-2016 WAS REVIEWED AND DETERMINED TO BE CONFORMING. CERTIFICATE OF COMPLIANCE SUPPLIED BY GENERAL MACHINE FOR OP #80 (COLORIZE) DATED 31-AUG-2016 WAS REVIEWED AND DETERMINED TO BE CONFORMING. THIS LOT MET ALL DIMENSIONAL, VISUAL AND PACKAGING CRITERIA AT THE TIME OF RELEASE WITH NO ISSUES DOCUMENTED DURING THE MANUFACTURE, INSPECTION OR RELEASE OF THE PRODUCT THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. DEVICE HISTORY BATCH NULL. DEVICE HISTORY REVIEW THIS LOT MET ALL DIMENSIONAL, VISUAL AND PACKAGING CRITERIA AT THE TIME OF RELEASE WITH NO ISSUES DOCUMENTED DURING THE INSPECTION OR RELEASE OF THE PRODUCT THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. INVESTIGATION SELECTION: IT WAS REPORTED THAT ON APRIL 30, 2019, A THREE (3) STARDRIVE SCREWDRIVERS AND A THREADED DRILL GUIDE WERE STRIPPED AND DAMAGED AND NO LONGER USEFUL WHILE THE SURGEON WAS PERFORMING METACARPAL FRACTURES. THE DRIVERS WERE PROBABLY TORQUED TO HARD CAUSING THEM TO BREAK. IT IS UNKNOWN IF THERE WAS A SURGICAL DELAY. PROCEDURE OUTCOME AND PATIENT STATUS WERE UNKNOWN. THIS COMPLAINT INVOLVES FOUR (4) DEVICES. INVESTIGATION FLOW: DAMAGE. VISUAL INSPECTION: THE RETURNED DEVICE WAS EXAMINED AND WAS FOUND THE DISTAL TIP WAS FOUND TO BE STRIPPED. THE OBSERVED DAMAGE IS CONSISTENT WITH THE REPORTED COMPLAINT CONDITION AS SUCH THE COMPLAINT CONDITION CAN BE CONFIRMED. NO FURTHER VISUAL DEFECTS OR DEFICIENCIES WERE NOTED. DIMENSIONAL INSPECTION: NO PRODUCT DESIGN ISSUES OR DISCREPANCIES WERE OBSERVED DURING THIS INVESTIGATION. CONCLUSION: A DEFINITIVE ROOT CAUSE FOR THE TIP TWISTING COULD NOT BE DETERMINED BASED ON THE PROVIDED INFORMATION. IT IS MOST LIKELY THAT EXCESSIVE FORCE DURING SCREW INSERTION OCCURRED AND IT CAN BE ASSUMED THAT A MECHANICAL OVERLOAD LED TO THE DEFORMATION OF THE SCREWDRIVER TIP. IN THIS RELATION OF THE VARIABLE ANGLE LOCKING HAND SYSTEM SURGICAL TECHNIQUE GUIDE CAN BE MENTIONED: "WHEN INSERTING SCREWS, USE A TWO-FINGER TIGHTENING TECHNIQUE." THE REPORTED COMPLAINT CONDITION 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. BASED ON THE INVESTIGATION FINDINGS, IT HAS BEEN DETERMINED THAT NO CORRECTIVE AND/OR PREVENTATIVE ACTION IS PROPOSED. 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.

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS 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 THAT ON (B)(6) 2019, A THREE (3) STARDRIVE SCREWDRIVERS AND A THREADED DRILL GUIDE WERE STRIPPED AND DAMAGED AND NO LONGER USEFUL WHILE THE SURGEON WAS PERFORMING METACARPAL FRACTURES. THE DRIVERS WERE PROBABLY TORQUED TO HARD CAUSING THEM TO BREAK. IT IS UNKNOWN IF THERE WAS A SURGICAL DELAY. PROCEDURE OUTCOME AND PATIENT STATUS WERE UNKNOWN. THIS REPORT IS FOR ONE (1) STARDRIVE SCRWDRVR SHFT/T4 50MM/SELF-RETAINING/HXC. THIS IS REPORT 3 OF 3 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    447750 STARDRIVE SCRWDRVR SHFT/T4 50MM/SELF-RETAINING/HXC SCREWDRIVER HXX WRIGHTS LANE SYNTHES USA PRODUCTS LLC 03.130.010 H082466 10886982075192

    Patients

    Seq Age Sex Outcome Treatment
    1