BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SCREW, FIXATION, BONE

    MDR report key: 4138097 · Received October 3, 2014

    Report

    Report Number
    2520274-2014-13731
    Event Type
    Injury
    Date Received
    October 3, 2014
    Report Date
    March 10, 2014
    Manufacturer
    SYNTHES USA
    Product Code
    HWC
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. (B)(6). DATE OF EVENT IS UNKNOWN. THIS REPORT IS FOR FOUR UNKNOWN SCREWS. FOUR SCREWS REPORTED FOR POSTOPERATIVE BREAKAGE. IT IS UNKNOWN WHICH OF THE 4 SCREWS FROM THE PART NUMBERS LISTED BELOW, BROKE POSTOPERATIVELY: 02.211.014, 02.211.016 & 02.211.020 - 2.7MM VARIABLE ANGLE LOCKING SCREW SELF-TAPING WITH T8 STARDRIVE RECESS14MM, 16MM, 20MM (510# K100776 ADDITIONAL PRODUCT CODE: HRS) OR 202.880 AND 202.886 - 2.7MM CORTEX SCREW SELF-TAPING WITH T8 STARDRIVE RECESS 20MM AND 26MM (510# K112583). SYNTHES IS UNABLE TO DETERMINE WHICH PART NUMBER POTENTIALLY CONTRIBUTED TO THE COMPLAINT EVENT. (B)(4) COCK-UP FOOT DEFORMITY WITH DIFFICULTY WALKING. INVESTIGATION COULD NOT BE COMPLETED, NO CONCLUSION COULD BE DRAWN AS NO DEVICE WAS RETURNED AND NO LOT NUMBER WAS PROVIDED. MANUFACTURING RECORDS COULD NOT BE REVIEWED WITHOUT A LOT NUMBER. 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

    (B)(4).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 THE PATIENT UNDERWENT SURGERY FOR HALLUX RIGIDUS (ADVANCED/CHRONIC OSTEOARTHRITIS OF THE 1ST METATARSOPHALANGEAL JOINT ¿ MTP). PODIATRIC INTERVENTION WAS PERFORMED ON (B)(6) 2010 USING A PIECE OF DISTRACTION BONE BLOCK. PATIENT WAS IMPLANTED WITH A PLATE AND SCREW CONSTRUCT. THE PLATE BROKE POSTOP, PAIN AND A NON-UNION WAS NOTED. THE HARDWARE WAS REMOVED AND PATIENT WAS REVISED ON (B)(6) 2010 TO A 2.4MM/2.7MM VA-LCP FIRST MTP FUSION PLATE, 2.7MM VARIABLE ANGLE LOCKING SCREWS AND 2.7MM CORTEX SCREWS. PATIENT HAD MULTIPLE FOLLOW UP VISITS AND X-RAYS STATUS POST ARTHRODESIS OF THE 1ST MTP JOINT. ON (B)(6) 2011 FOLLOW UP VISIT AND X-RAYS TAKEN OF THE RIGHT FOOT. PATIENT WITH ADVANCED 1ST MTP JOINT OSTEOARTHRITIS AND HALLUX RIGIDUS IS STATUS POST CORRECTIVE ARTHRODESIS OF THE 1ST MTP JOINT FIXED WITH A DORSAL PLATE AND MULTIPLE SCREWS AS WELL AS 2 CROSSED SCREWS ACROSS THE JOINT. MEDIAN EMINECTOMY OF THE 1ST METATARSAL HEAD. OSSIFICATION IS PRESENT AT THE INTERFACE. ON (B)(6) 2011 FOLLOW UP VISIT AND X-RAYS TAKEN OF THE RIGHT FOOT. THE MOST DISTAL AND 3 MOST PROXIMAL DORSAL SCREWS ARE FRAGMENTED. REMAINING HARDWARE APPEARS INTACT. DEGENERATIVE CHANGES OF THE HINDFOOT, MIDFOOT AND FOREFOOT ARE STABLE. CALCANEAL ENTHESOPATHY IS NOTED. POSTSURGICAL CHANGES RELATED TO 1ST MTP ARTHRODESIS WITH INTERVAL FRAGMENTATION OF 4 DORSAL SCREWS. ON (B)(6) 2011 FOLLOW UP VISIT AND X-RAYS TAKEN OF THE RIGHT FOOT. PATIENT HAS CHRONIC SWELLING AND INFLAMMATION OVER THE RIGHT GREAT TOE AND PERSISTENT PAIN WITH AMBULATION. PATIENT HAS COCK-UP FOOT DEFORMITY WITH DIFFICULTY WALKING. X-RAYS SHOWED A NONUNION WITH MULTIPLE SCREWS AND A PLATE FAILURE. SURGERY WAS DONE TWICE, WITH HARDWARE FAILURE TWICE ((B)(6) 2010). ON (B)(6) 2011 FOLLOW UP VISIT AND CT SCANS TAKEN OF THE RIGHT FOOT. 1ST MTP JOINT FROM PRIOR FUSION WITH A DORSAL PLATE AND MULTIPLE SCREWS REMAINING IN UNCHANGED ALIGNMENT. RE-DEMONSTRATION OF EXTENSIVE HARDWARE FAILURE WITH FRACTURE OF MULTIPLE SCREWS AND MILD LIFTING OF THE DORSAL PLATE WITHOUT SIGNIFICANT INTERVAL CHANGE FROM (B)(6) 2011. MULTIPLE OSSIFIC FRAGMENTS AT THE 1ST MTP JOINT. ADVANCED OSTEOARTHRITIC CHANGES AT THE SESAMOID ARTICULATION AND MODERATE MIDFOOT DEGENERATIVE CHANGES MOST PROMINENT AT THE 3RD AND 4TH TARSOMETATARSAL JOINTS. MILD HINDFOOT OSTEOARTHRITIC CHANGES ARE ALSO IDENTIFIED. CALCANEAL ENTHESOPATHY IS MOST PROMINENT AT THE ORIGIN OF THE MEDIAL PLANTAR FASCIA. HELICAL CT IMAGES TAKEN . CT SCAN SHOWS 1ST MTP NONUNION. ADVANCED OSTEOARTHRITIC CHANGES OF THE SESAMOID ARTICULATION WITH MILD TO MODERATE MIDFOOT AND HINDFOOT OSTEOARTHRITIS. ON (B)(6) 2011 FOLLOW UP VISIT ¿SEDIMENTATION RATE AND C-REACTIVE PROTEIN (CRP) WERE NORMAL. CT SCAN SHOWS A PERSISTENT NONUNION THROUGH THE MTP JOINT. PLANS FOR REVISION SURGERY TO REMOVE THE HARDWARE, DEBRIDEMENT AND DO A SLIDING GRAFT TECHNIQUE TO ACHIEVE FUSION WITH CALCANEAL BONE GRAFT. ON (B)(6) 2011, PATIENT UNDERWENT REVISION SURGERY TO REMOVE PLATE AND SCREW CONSTRUCT. CULTURES TAKEN OF RIGHT FOOT INTRAOPERATIVELY ON (B)(6) 2011¿NO ORGANISMS SEEN. AVASCULAR AREA DEBRIDED AND SLIDING GRAFT TECHNIQUE WAS PERFORMED FOR THE NONUNION. CALCANEAL BONE GRAFT HARVESTED AND PACKED INTO NONUNION AREA TO ASSIST EARLY BONE HEALING. OLD HARDWARE WAS REMOVED AND A BROKEN SCREW REMOVAL SET WAS USED TO REMOVE ANY REMAINING SCREWS. ONCE ALL HARDWARE WAS REMOVED, BONE GRAFT WAS APPLIED. THE SLIDING GRAFT WAS APPLIED OVER THE 1ST MTP JOINT, AND A NEW PLATE-SYNTHES VARIABLE ANGLE LOCKING PLATE WAS PLACED. FLUOROSCOPY AT THE END OF THE PROCEDURE SHOWED GOOD ALIGNMENT. THIS COMPLAINT INVOLVES FIVE DEVICES (POSTOPERATIVE PLATE BREAKAGE AND MILD LIFTING OF PLATE X 1 AND POSTOPERATIVE SCREW BREAKAGE X 4) FOR THE SURGERY DATE OF (B)(6) 2010 AND EXPLANT OF HARDWARE ON (B)(6) 2011. THIS REPORT IS FOR FOUR UNKNOWN SCREWS. THIS IS REPORT 2 OF 2 FOR (B)(4).

    Description of Event or Problem · 1

    PATIENT RECENTLY PASSED AWAY. THE DATE AND CAUSE OF DEATH WAS NOT PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    618707 SCREW, FIXATION, BONE HWC SYNTHES USA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention