BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    2.5MM HEX SCREWDRIVER-LONG

    MDR report key: 5438389 · Received February 16, 2016

    Report

    Report Number
    1719045-2016-10131
    Event Type
    Malfunction
    Date Received
    February 16, 2016
    Date of Event
    January 25, 2016
    Report Date
    January 25, 2016
    Manufacturer
    SYNTHES MONUMENT
    Product Code
    HXX
    PMA / PMN Number
    PEXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT INVESTIGATION SUMMARY: THE FOLLOWING COMPLAINT DEVICE WAS RECEIVED FOR EVALUATION: ONE (1) 2.5MM HEX SCREWDRIVER-LONG (PART: 388.395 / LOT: 5243239) THE COMPLAINT CONDITION FOR THE BROKEN TIP OF THE SCREWDRIVER WAS LIKELY CAUSED BY THE APPLICATION OF EXCESSIVE FORCE BEING APPLIED TO THE DRIVER TO REMOVE A SET SCREW OR MATERIAL FATIGUE DUE TO REPEATED LOADING AND UNLOADING. THE 2.5MM HEX SCREWDRIVER-LONG IS MENTIONED IN FIVE TECHNIQUE GUIDES INCLUDING: UNIVERSAL SPINAL SYSTEM, CANNULATED PANGEA SYSTEM, AXON SYSTEM, PANGEA DEGENERATIVE SPINE, AND PANGEA SYSTEM. THE SCREWDRIVER IS USED TO TIGHTEN SET SCREWS OF TRANSCONNECTORS. THE RETURNED INSTRUMENT WAS EVALUATED AND THE COMPLAINT CONDITION OF BROKEN TIP WAS ABLE TO BE CONFIRMED. APPROXIMATELY 2.1MM OF THE DISTAL TIP IS BROKEN OFF FROM THE DEVICE AND WAS NOT RETURNED. THE BREAK APPEARS TO BE COUNTER CLOCKWISE DIRECTION; THEREFORE, IT MOST LIKELY HAPPENED DURING REMOVAL. MECHANICAL TESTING HAS SHOWN THAT THE HEXAGONAL SCREWDRIVER IS ABLE TO WITHSTAND 5.65 +/- .111NM TORQUE AND IS SUFFICIENT FOR TIGHTENING THE SET SCREWS OF TRANSCONNECTORS. NO DEFINITIVE ROOT CAUSE COULD BE DETERMINED; HOWEVER, THE FAILURE MODE IS TYPICALLY ASSOCIATED WITH THE APPLICATION OF EXCESS TORQUE FOR THE TIGHTENING OF SET SCREWS. THE DRAWINGS WERE REVIEWED. THE DESIGN HISTORY WAS FOUND TO NOT IMPACT THE COMPLAINT CONDITION. DURING THE INVESTIGATION, NO PRODUCT DESIGN ISSUES OR DISCREPANCIES WERE OBSERVED THAT MAY HAVE CONTRIBUTED TO THE COMPLAINT CONDITION. THE RETURNED PART WAS DETERMINED TO BE SUITABLE FOR THE INTENDED USE WHEN EMPLOYED AND MAINTAINED AS RECOMMENDED. DURING THE INVESTIGATION, NO PRODUCT DESIGN ISSUES OR DISCREPANCIES WERE OBSERVED THAT MAY HAVE CONTRIBUTED TO THE COMPLAINT CONDITION. DEVICE 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. A PRODUCT DEVELOPMENT INVESTIGATION WAS PERFORMED FOR THE SUBJECT DEVICE (HELICAL BLADE COUPLING SCREW, PART NUMBER 357.377, LOT NUMBER 6773719). THE SUBJECT DEVICE WAS RECEIVED WITH THE FOLLOWING COMPLAINT DESCRIPTION: ¿DURING A LUMBO-PELVIC FUSION ON (B)(6) 2016, A SMALL HEXAGONAL SCREWDRIVER TIP BROKE OFF WHILE TRYING TO TIGHTEN THE SCREW HEAD. THE PIECES WERE EASILY LOCATED AND REMOVED WITH NO HARM TO THE PATIENT OR SURGEON.¿ THE 2.5MM HEX SCREWDRIVER-LONG IS MENTIONED IN FIVE TECHNIQUE GUIDES INCLUDING: UNIVERSAL SPINAL SYSTEM, CANNULATED PANGEA SYSTEM, AXON SYSTEM, PANGEA DEGENERATIVE SPINE, AND PANGEA SYSTEM. THE SCREWDRIVER IS USED TO TIGHTEN SET SCREWS OF TRANSCONNECTORS. THE PRODUCT DRAWINGS WERE REVIEWED. THE DESIGN HISTORY WAS FOUND TO NOT IMPACT THE COMPLAINT CONDITION. DURING THE INVESTIGATION NO PRODUCT DESIGN ISSUES OR DISCREPANCIES WERE OBSERVED THAT MAY HAVE CONTRIBUTED TO THE COMPLAINT CONDITION. THE RETURNED PART WAS DETERMINED TO BE SUITABLE FOR THE INTENDED USE WHEN EMPLOYED AND MAINTAINED AS RECOMMENDED. THE RETURNED INSTRUMENT WAS EVALUATED AND THE COMPLAINT CONDITION OF BROKEN TIP WAS ABLE TO BE CONFIRMED. APPROXIMATELY 2.1MM OF THE DISTAL TIP IS BROKEN OFF FROM THE DEVICE AND WAS NOT RETURNED. THE BREAK APPEARS TO BE COUNTER CLOCKWISE DIRECTION THEREFORE IT MOST LIKELY HAPPENED DURING REMOVAL. MECHANICAL TESTING HAS SHOWN THAT THE HEXAGONAL SCREWDRIVER IS ABLE TO WITHSTAND 5.65 +/- .111NM TORQUE AND IS SUFFICIENT FOR TIGHTENING THE SET SCREWS OF TRANSCONNECTORS. NO DEFINITIVE ROOT CAUSE COULD BE DETERMINED HOWEVER THE FAILURE MODE IS TYPICALLY ASSOCIATED WITH THE APPLICATION OF EXCESS TORQUE FOR THE TIGHTENING OF SET SCREWS. 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. THE LOT NUMBER PROVIDED (563963E06) IS THE SUPPLIER LOT NUMBER. THE SYNTHES LOT NUMBER IS (5243239). 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: DHR REVIEW FOR PART# 388.395 SUPPLIER LOT# 563963E06, SYNTHES LOT# 5243239. RELEASE TO WAREHOUSE DATE: 11MAY2006, SUPPLIER: (B)(4), NO NCRS WERE GENERATED DURING PRODUCTION. 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. 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 LUMBO-PELVIC FUSION ON (B)(6) 2016, A SMALL HEXAGONAL SCREWDRIVER TIP BROKE OFF WHILE TRYING TO TIGHTEN THE SCREW HEAD. THE PIECES WERE EASILY LOCATED AND REMOVED WITH NO HARM TO THE PATIENT OR SURGEON. THE PATIENT'S OUTCOME WAS REPORTED AS FAIR. THERE WAS NO SURGICAL DELAY AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THIS REPORT IS 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    96774 2.5MM HEX SCREWDRIVER-LONG SCREWDRIVERS HXX SYNTHES MONUMENT 5243239

    Patients

    Seq Age Sex Outcome Treatment
    1