BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SCREW, FIXATION, BONE

    MDR report key: 5174405 · Received October 24, 2015

    Report

    Report Number
    2520274-2015-16816
    Event Type
    Injury
    Date Received
    October 24, 2015
    Report Date
    October 9, 2015
    Manufacturer
    SYNTHES USA
    Product Code
    HWC
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL PRODUCT CODES (BASED UPON PARTIAL PART FAMILY 02.211.0XX) FOR THIS DEVICE INCLUDE HRS. BASED UPON THE PART FAMILY IDENTIFIED IN THE INVESTIGATION, THE LIKELY 510K NUMBERS FOR THESE SCREWS INCLUDE: K103243 AND K100776. PRODUCT INVESTIGATION SUMMARY: PRODUCT INVESTIGATION SUMMARY: ONE 2.4/2.7MM VARIABLE ANGLE LOCKING COMPRESSION PLATE (VA-LCP) FIRST MTP FUSION PLATE & 5 UNKNOWN SCREWS (3 BROKEN & 2 INTACT) WERE RECEIVED. THE COMPLAINT CONDITION IS CONFIRMED FOR THE 3 BROKEN SCREWS & UNCONFIRMED FOR THE 2 INTACT SCREWS & 1 UNRETURNED SCREW. THE BREAKS ARE CONSISTENT WITH THE RESULT OF EXCESSIVE SHEAR FORCES. WHEN THERE IS INSUFFICIENT REDUCTION DELAYED HEALING, THERE ARE INCREASED LOADS THE IMPLANT MUST WITHSTAND. THIS INCREASED LOAD COULD EVENTUALLY CAUSE BREAKAGE DUE TO METAL FATIGUE. THIS IS FURTHER IMPACTED BY PATIENT COMPLIANCE, ACTIVITY LEVEL, COMORBIDITIES, & THE SURGICAL TECHNIQUE. SINCE THE SPECIFIC CONDITIONS AT THE TIME OF THE BREAK ARE UNKNOWN, THE ROOT CAUSE CANNOT BE DETERMINED. THE RETURNED PARTS WERE DETERMINED TO BE SUITABLE FOR THEIR INTENDED USE WHEN EMPLOYED & MAINTAINED AS RECOMMENDED. FURTHER EVALUATION SHOWS THAT THE IMPLANTS ARE PART OF THE VA-LCP FOREFOOT/MIDFOOT SYSTEM. THE FIRST MTP FUSION PLATES ARE SPECIFICALLY INTENDED FOR FIXATION OF FUSIONS & NONUNIONS OF THE FIRST MTP JOINT & FIXATION OF FRACTURES, OSTEOTOMIES, NONUNIONS, & RE-PLANTATIONS OF THE FIRST METATARSAL BONE. THREE BROKEN SCREWS & 2 INTACT SCREWS WERE RECEIVED. THE 2 INTACT SCREWS SHOW WEAR TO THE THREADED SHAFTS & DEFORMATION TO THE THREADED HEADS. THESE CONDITIONS ARE CONSISTENT WITH IMPLANT & SUBSEQUENT EXPLANT & HAVING WITHSTOOD THE FORCES OF AN EXTENDED NONUNION. THE OTHER 3 SCREWS WERE RECEIVED WITH A ROUGHLY TRANSVERSE BREAK IN THE THREADED SHAFT REGION. IN ALL 3 CASES THE DISTAL THREADS WERE NOT RECEIVED. TWO OF THE RECEIVED SCREW HEADS ARE RETAINED IN THE PLATE AND BROKEN DIRECTLY BELOW THE SCREW HEAD. THE 3RD SCREW WAS RECEIVED LOOSE FROM THE PLATE & BROKEN APPROXIMATELY 5.65MM FROM THE PROXIMAL END OF THE SCREW. THE FRACTURE SITE WAS EXAMINED & NO MATERIAL VOIDS OR IRREGULARITIES WERE IDENTIFIED. IT WAS REPORTED SIX 2.7MM VA LOCKING SCREWS WERE NOTED AS BROKEN; HOWEVER, ONLY THREE BROKEN SCREWS & TWO INTACT SCREWS WERE RECEIVED. THUS, THE COMPLAINT CONDITION IS ONLY CONFIRMED & CONSISTENT WITH THE REPORTED CONDITION FOR THE 3 BROKEN SCREWS. REPLICATION OF THE COMPLAINT CONDITION IS NOT APPLICABLE AS THE SCREWS ARE ALREADY BROKEN. BASED ON THE OBTAINABLE FEATURES OF THE RETURNED SCREWS, & THE REPORTED INFORMATION INDICATING THAT THEY WERE 2.7MM VARIABLE ANGLE LOCKING SCREWS, THE RECEIVED SCREWS WERE DETERMINED TO LIKELY BE FROM THE 2.7MM VARIABLE ANGLE LOCKING SCREWS, SELF-TAPPING, WITH T8 STARDRIVE RECESS FAMILY (PART 02.211.0XX). HOWEVER, GIVEN THE DAMAGE THE EXACT PART NUMBERS COULD NOT BE DETERMINED. A REVIEW OF THE DESIGN DRAWING FOR THE PROBABLE SCREW FAMILY WAS PERFORMED. DURING THE INVESTIGATION, NO PRODUCT DESIGN ISSUES OR DISCREPANCIES WERE OBSERVED THAT MAY HAVE CONTRIBUTED TO THE COMPLAINT CONDITION. THE RETURNED PARTS WERE DETERMINED TO BE SUITABLE FOR THEIR INTENDED USE WHEN EMPLOYED & MAINTAINED AS RECOMMENDED. 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

    DATE RETURNED TO MANUFACTURER. 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 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

    THIS REPORT IS FOR ONE (1) UNKNOWN 2.7MM VA-LOCKING SCREW. THE ORIGINAL IMPLANT PROCEDURE TOOK PLACE ON AN UNKNOWN DATE APPROXIMATELY ONE (1) YEAR AGO. THE COMPLAINANT PART IS EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION, BUT HAS YET TO BE RECEIVED. (B)(4). INVESTIGATION COULD NOT BE COMPLETED AND NO CONCLUSION COULD BE DRAWN AS NO DEVICE WAS RETURNED. WITHOUT A LOT NUMBER, THE DEVICE HISTORY RECORD REVIEW COULD NOT BE REQUESTED. 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.

    Description of Event or Problem · 1

    IT WAS ORIGINALLY REPORTED THAT ALL SIX (6) SCREW HEADS WERE BROKEN. A TOTAL OF FIVE (5) SCREWS WERE RETURNED BY THE FACILITY ON OCTOBER 26, 2015 FOR MANUFACTURER EVALUATION. DURING THE PRODUCT INVESTIGATION, WHICH WAS COMPLETED ON NOVEMBER 18, 2015, IT WAS DISCOVERED THAT TWO (2) OF THE EXPLANTED SCREWS WERE IN FACT INTACT. THE OTHER THREE (3) RECEIVED SCREWS WERE BROKEN AS INITIALLY REPORTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PATIENT UNDERWENT A METATARSOPHALANGEAL JOINT FUSION (MTP) PROCEDURE ON THE LEFT SIDE, APPROXIMATELY ONE (1) YEAR AGO. PATIENT WAS IMPLANTED WITH A 2.4/2.7MM VARIABLE ANGLE - LOCKING COMPRESSION PLATE (VA-LCP) FIRST MTP FUSION PLATE AND A QUANTITY OF SIX (6) 2.7MM VA LOCKING SCREWS. DURING A ROUTINE FOLLOW UP VISIT, ON AN UNKNOWN DATE, SIX (6) BROKEN SCREWS AND A NON-UNION WERE DISCOVERED VIA X-RAY. THE HEAD ON ALL SIX (6) SCREWS HAD BROKEN OFF. THE PLATE REMAINED INTACT. THE PATIENT UNDERWENT A REVISION SURGERY ON (B)(6), 2015 DURING WHICH THE PLATE AND THE HEADS AND SHAFTS OF FIVE (5) OF THE BROKEN SCREWS WERE REMOVED. THE SURGEON WAS UNABLE TO COMPLETELY REMOVE THE SIXTH SCREW. ONLY THE HEAD OF THE SIXTH SCREW WAS REMOVED AND THE SHAFT REMAINS IN THE PATIENT. THE PATIENT WAS REVISED TO A SYNTHES MTP FUSION PLATE AND SYNTHES SCREWS. THERE WAS NO DELAY IN SURGERY AND THE REVISION WAS COMPLETED. THIS REPORT IS FOR ONE (1) UNKNOWN 2.7MM VA-LOCKING SCREW. THIS REPORT IS 3 OF 3 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    703378 SCREW, FIXATION, BONE HWC SYNTHES USA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention