BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOOK OR SCREW HOLDER

    MDR report key: 5135974 · Received October 8, 2015

    Report

    Report Number
    2520274-2015-16483
    Event Type
    Malfunction
    Date Received
    October 8, 2015
    Date of Event
    September 25, 2015
    Report Date
    September 25, 2015
    Manufacturer
    SYNTHES USA
    Product Code
    LXH
    PMA / PMN Number
    PEXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. ADDITIONAL PRODUCT CODE: GDG. DHR ATTEMPTED, LOT # & PART # COMBINATION INVALID, NO DHR COULD BE FOUND FOR ITEM 388.61- LOT # 4723087. THEREFORE A DHR REVIEW CAN NOT BE PERFORMED. THE LOT# PROVIDED 4723087 IS ASSOCIATED WITH A COMPONENT PART # 388.61.02 (COLLAR). DEVICE IS AN INSTRUMENT AND IS NOT IMPLANTED/EXPLANTED. DEVICE IS EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. A REVIEW OF THE DEVICE HISTORY RECORDS HAS BEEN REQUESTED. 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

    AN INVESTIGATION SUMMARY WAS PERFORMED. THE INVESTIGATION OF THE COMPLAINT ARTICLES HAS SHOWN THAT ONE HOOK/SCREW HOLDER (PART# 388.61, LOT# 4723087) AND ONE 3.5MM HEXAGONAL SCREWDRIVER (PART# 388.224, LOT# 1646175) WERE RETURNED BROKEN AT THE TIP. DURING REMOVAL OF A USS VAS CONSTRUCT, A LARGE AMOUNT OF TORQUE MAY HAVE BEEN REQUIRED TO REMOVE SCREWS, CAUSING THE TIPS ON THE INSTRUMENTS TO BREAK. EXCESSIVE TORQUE DURING SCREW REMOVAL MAY HAVE CAUSED THE BREAKAGES ON THE HOLDER (PART# 388.61) AND HEX DRIVER (PART# 389.224). A DEFINITIVE ROOT CAUSE COULD NOT BE DETERMINED. THE COMPLAINT CONDITIONS FOR THESE TWO DEVICES ARE CONFIRMED. NO DESIGN ISSUES WERE NOTED DURING THE EVALUATION. THIS INVESTIGATION SUMMARY IS APPROVE. 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

    SUBJECT DEVICE HAS BEEN RECEIVED AND IS CURRENTLY IN THE EVALUATION PROCESS. INVESTIGATION IS ONGOING; NO CONCLUSION COULD BE DRAWN AS PRODUCT IS ENTERING THE COMPLAINT SYSTEM. DEVICE HISTORY RECORDS WAS CONDUCTED. THE REPORT INDICATES THAT THE: LOT # 4723087/ PART # 388.61 COMBINATION INVALID, NO DHR COULD BE FOUND FOR ITEM 388.61- LOT # 4723087. THEREFORE A TOP LEVEL DHR REVIEW CANNOT BE PERFORMED. THE LOT# PROVIDED 4723087 IS ASSOCIATED WITH A COMPONENT PART # 388.61.02 (OUTER SLEEVE). MANUFACTURED AT (B)(4) AND RELEASED TO ASSEMBLY WAREHOUSE SEPT 13, 2004. MRR #53447 WAS WRITTEN FOR OUTER SLEEVE COMPONENT PART#388.61.02 LOT#4723087 FOR VENDOR PERFORMING HEAT TREAT CERTIFICATION WHEN PARTS WERE TO BE HEAT TREATED IN-HOUSE BY SYNTHES, NOT HEAT TREATED BY VENDOR. THE LOT WAS REWORKED/REINSPECTED (CHECK HEAT TREAT SLUG FOR HARDNESS MIN RC40 AND PASSED INSPECTION. THIS MRR IS NOT RELEVANT TO THE COMPLAINT CONDITION (TIP BROKEN INTRAOPERATIVE) AS HEAT TREAT OPERATION WAS PERFORMED BY VENDOR TO SPECIFICATION. (B)(4) WAS WRITTEN FOR OUTER SLEEVE COMPONENT PART#388.61.02 LOT#4723087 FOR UNDERSIZED D1 FEATURE THIS MRR IS NOT RELEVANT TO THE COMPLAINT CONDITION (TIP BROKEN INTRAOPERATIVE) AS UNDERSIZED D1 FEATURE (INSIDE DIAMETER) WOULD LEAD TO LARGER WALL THICKNESS. REVIEW OF THE DEVICE HISTORY RECORD(S) SHOWED THAT THERE WERE NO ISSUES DURING THE MANUFACTURE OF THIS PRODUCT THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. 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: PATIENT PRESENTED IN THE OR WITH PREVIOUS INSTRUMENTED FUSION AT L4/5 AND L5/S1. THE REASON AND DATE/YEAR FOR ORIGINAL FUSION IS UNKNOWN. PATIENT WAS ORIGINALLY IMPLANTED WITH POSTERIOR LUMBAR FUSION USING UNIVERSAL SPINAL VARIABLE AXIS SCREW SYSTEM (USS VAS). ON (B)(6), 2015, PATIENT WAS SCHEDULED FOR REVISION SURGERY WITH L3-L4 POSTERIOR FUSION WITH INTERBODY FUSION USING USS HARDWARE DUE TO DEGENERATIVE DISC DISEASE AT THE L4 LEVEL. DURING REVISION SURGERY, SURGEON ATTEMPTED TO REMOVE ALL PREVIOUS CONSTRUCT IMPLANTS, BUT 2 SCREWS AT THE S1 LEVEL WERE TOO DIFFICULT TO REMOVE AND REMAIN IMPLANTED IN THE PATIENT. SURGEON REMOVED THE OTHER 4 SACRAL SCREWS, TWO RODS, 6 COLLARS, AND 6 NUTS. WHILE THE SURGEON WAS ATTEMPTING TO REMOVE THE SACRAL SCREWS AT AN UNKNOWN DISC LEVEL THE HEX DRIVER TIP BROKE OFF. A FRAGMENT WAS GENERATED. FRAGMENT WAS RETRIEVED AND DISPOSED OF BY THE HOSPITAL. REVISION FUSION SURGERY WAS COMPLETED SUCCESSFULLY. ANOTHER INSTRUMENT WAS AVAILABLE AND PROCEDURE WAS COMPLETED WITH NO REPORTED SURGICAL TIME EXTENSION. THIS REPORT IS 2 OF 7 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    665419 HOOK OR SCREW HOLDER MISC ORTHO SURGICAL INSTRUMENT LXH SYNTHES USA 4723087

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR