BEUDAMED
    FDA Adverse Event Injury Summary report: N

    3.5MM LOCKING SCREW SLF-TPNG W/STARDRIVE(TM) RECESS 34MM

    MDR report key: 4820823 · Received June 5, 2015

    Report

    Report Number
    2520274-2015-14269
    Event Type
    Injury
    Date Received
    June 5, 2015
    Report Date
    May 28, 2015
    Manufacturer
    SYNTHES USA
    Product Code
    JDS
    PMA / PMN Number
    PK072095
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    WITHOUT A LOT NUMBER THE DEVICE HISTORY RECORD REVIEW AND THE INVESTIGATION COULD NOT BE COMPLETED. AN INVESTIGATION SUMMARY WAS PERFORMED. THE INVESTIGATION OF THE COMPLAINT ARTICLES HAS SHOWN THAT: THE LCP PERIARTICULAR PROXIMAL HUMERUS PLATES ARE INDICATED FOR FRACTURES, FRACTURE DISLOCATIONS, OSTEOTOMIES, AND NONUNIONS OF THE PROXIMAL HUMERUS. THE TECHNIQUE GUIDE (J9083-B) RECOMMENDS INSERTING CORTEX SCREWS FIRST TO PULL THE PLATE TO THE BONE AND TO AID IN REDUCTION OF ANY DISTAL SHAFT FRAGMENTS. THE TECHNIQUE GUIDE ALSO STATES TO USE STANDARD AO SCREW INSERTION TECHNIQUE TO INSERT 3.5MM CORTEX SCREWS IN THE DCU PORTION OF THE COMBI HOLES. THE COMPLAINT DESCRIPTION STATES THAT THE SCREWS BROKE TEN MONTHS POST A HUMERAL FRACTURE REVISION. IT IS LIKELY THAT THE BONE DID NOT HEAL CAUSING THE 4 SCREWS DISTAL TO THE FRACTURE TO FATIGUE AND FAIL. NOT FOLLOWING THE RECOMMENDED TECHNIQUE MAY HAVE ALSO CONTRIBUTED TO THE SCREW BREAKAGE. (B)(4) WAS REVIEWED DURING THE EVALUATION AND NO ISSUES WERE FOUND. 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

    THE DEVICE WAS RECEIVED, THE INVESTIGATION COULD NOT BE COMPLETED, AND 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT BROKEN SCREWS WERE DISCOVERED APPROXIMATELY TEN MONTHS POST A HUMERAL FRACTURE REVISION PROCEDURE OF (B)(6) 2014. THE PATIENT BEGAN TO EXPERIENCE PAIN (WITH NO TRAUMA OCCURRING) IN (B)(6) 2015; X-RAYS OF (B)(6) 2015 SHOWED FOUR BROKEN SCREWS. IT WAS REPORTED THAT THE CONSTRUCT CONSISTS OF A PLATE AND ELEVEN SCREWS. THE PATIENT SUSTAINED A RIGHT HUMERUS FRACTURE WHEN SHE TRIPPED AND FELL WHILE WALKING A DOG ON (B)(6) 2012. IT WAS REPORTED THAT ORIGINALLY IT WAS "LEFT TO HEAL ON ITS OWN". WHEN IT DID NOT HEAL, IT WAS DISCOVERED THAT THE "BICEPS WERE IMPALED BETWEEN THE BONE". IN 2013, A PROCEDURE INVOLVING A PLATE AND SCREWS WAS PERFORMED. AFTER ONE YEAR, THIS CONSTRUCT "FELL APART", AND A REVISION WAS PERFORMED IN (B)(6) 2014. THIS IS REPORT 8 OF 9 FOR COM-(B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    364516 3.5MM LOCKING SCREW SLF-TPNG W/STARDRIVE(TM) RECESS 34MM NAIL,FIXATION,BONE JDS SYNTHES USA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention