BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HOOK OR SCREW HOLDER

    MDR report key: 5277691 · Received December 9, 2015

    Report

    Report Number
    1719045-2015-10804
    Event Type
    Injury
    Date Received
    December 9, 2015
    Date of Event
    November 17, 2015
    Report Date
    November 17, 2015
    Manufacturer
    SYNTHES MONUMENT
    Product Code
    LXH
    PMA / PMN Number
    PEXEMPT
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(6). A PRODUCT INVESTIGATION WAS COMPLETED: ONE HOOK/SCREW HOLDER (PART 388.61, LOT 6526674, MANUFACTURE JANUARY 2012) WAS RETURNED BROKEN AT THE TIP. DURING REMOVAL OF THE UNIVERSAL SPINE SYSTEM (USS) AND USS VARIABLE AXIS SCREW (VAS) CONSTRUCT, A LARGE AMOUNT OF TORQUE MAY HAVE BEEN REQUIRED TO TIGHTEN THE SCREWS, CAUSING THE TIPS ON THE HOOK/SCREW HOLDER TO BREAK. THE COMPLAINT CONDITION FOR THIS DEVICE IS CONFIRMED. THE HOOK/SCREW HOLDER (PART 388.61) IS AN INSTRUMENT IN THE UNIVERSAL SPINE SYSTEM (USS) AND USS VARIABLE AXIS SCREW (VAS) SYSTEM. THE HOLDER IS USED TO PLACE HOOKS, INSERT SCREWS AND PROVISIONALLY TIGHTEN THE CONSTRUCT (SECURE THE NUTS). THE RELEVANT PRODUCT DRAWINGS WERE REVIEWED DURING THE EVALUATION. THE HOLDER WAS RETURNED WITH A BROKEN THREADED TIP. THE REPORTER STATED THAT THE TIP OF THE HOOK/SCREW HOLDER BROKE DURING FINAL TIGHTENING. EXCESSIVE TORQUE DURING INSERTION MAY HAVE CAUSED THE BREAKAGE. THE COMPLAINT CONDITION FOR THIS DEVICE COULD NOT BE REPLICATED. DEVICE HISTORY RECORD REVIEWS SHOWED THAT THERE WERE NO ISSUES DURING THE MANUFACTURE OF THE PRODUCT THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. THERE IS INSUFFICIENT INFORMATION AVAILABLE TO DETERMINE THE TRUE ROOT CAUSE OF THE FAILURE. FROM THE COMPLAINT DESCRIPTION AND THE CONDITION OF THE RETURNED ITEM, THE MOST LIKELY ROOT CAUSE OF THE INTRAOPERATIVE DEVICE FAILURE IS EXCESSIVE TORQUE USED TO TIGHTEN THE SCREW. TECHNIQUE GUIDES FOR BOTH THE USS AND USS VAS BOTH EMPHASIZE THAT A 10NM TORQUE WRENCH MUST BE USED FOR FINAL CONSTRUCT TIGHTENING. 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

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. PATIENT WEIGHT NOT PROVIDED BY REPORTER. ADDITIONAL PRODUCT CODE: GDG. DEVICE IS AN INSTRUMENT AND IS NOT IMPLANTED/EXPLANTED. 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: MANUFACTURING LOCATION: (B)(4), MANUFACTURING DATE: 1/10/2012, PART #: 388.61, LOT#: 6526674 (NON-STERILE) - HOOK OR SCREW HOLDER. QUANTITY (B)(4). LOT WAS RELEASE TO THE WAREHOUSE ON 1/10/2012. WORK ORDER NO: (B)(4) WERE ISSUED ON 1/15/2012. 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. 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 A REVISION SURGERY OF A L2-S1 POSTERIOR FUSION WITH SYNTHES USS, THE TIP OF THE HOOK/SCREW HOLDER BROKE WHILE FINAL TIGHTENING OF THE L3 SCREW. THE SURGEON DID NOT WANT TO REMOVE THE SCREW THAT CONTAINED THE SCREW HOLDER FRAGMENT AND THE FRAGMENT REMAINS IN THE PATIENT. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THE USS SCREW SIZE ON THE RIGHT L3 SCREW IS UNKNOWN. THIS REPORT IS 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    808950 HOOK OR SCREW HOLDER MISC ORTHO SURGICAL INSTRUMENT LXH SYNTHES MONUMENT 6526674

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Required Intervention