BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NAIL, FIXATION, BONE

    MDR report key: 5770549 · Received July 5, 2016

    Report

    Report Number
    2520274-2016-13355
    Event Type
    Injury
    Date Received
    July 5, 2016
    Report Date
    June 21, 2016
    Manufacturer
    SYNTHES USA
    Product Code
    JDS
    PMA / PMN Number
    K072095
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    BASED ON THE PROVIDED PARTIAL PART NUMBER (212.1XX), THE PART BELONGS TO A FAMILY OF 3.5MM LOCKING SCREWS SELF-TAPPING WITH STARDRIVE RECESS (VARYING LENGTHS). THE ASSOCIATED PRO-CODE IS JDS ¿ NAIL, FIXATION, BONE. THE LIKELY 510K NUMBER, BASED UPON PARTIAL PART NUMBER, IS K072095. PRODUCT INVESTIGATION SUMMARY: TWO (2) HEADS AND TWO (2) SHAFTS FROM PART FAMILY 212.1XX, AS WELL AS TWO (2) HEADS AND ONE (1) SHAFT FROM PART FAMILY 204.8XX WERE RECEIVED FOR INVESTIGATION. DUE TO THE DAMAGES, THE EXACT PART NUMBERS CANNOT BE DETERMINED. THE DEVICES WERE REPORTED TO HAVE BROKEN POST-OPERATIVELY. THE THREADS ON THE SHAFTS ARE SEVERELY WORN AND DULL, CONSISTENT WITH WEAR FROM BEING IMPLANTED AND RUBBING AGAINST ANOTHER METALLIC OBJECT. THE HEADS EXHIBIT SLIGHT WEAR AND DEFORMATION CONSISTENT WITH IMPLANTATION BY A SCREWDRIVER. IT IS UNKNOWN WHAT CAUSED THE DEVICES TO BREAK POST-OPERATIVELY, BUT IT IS LIKELY DUE TO FATIGUE FAILURE. DURING THE INVESTIGATION, NO PRODUCT DESIGN ISSUES OR DISCREPANCIES WERE OBSERVED THAT MAY HAVE CONTRIBUTED TO THE COMPLAINT CONDITION. A VISUAL INSPECTION AND DRAWING REVIEW WERE PERFORMED AS PART OF THIS INVESTIGATION. NO PRODUCT DESIGN ISSUES OR DISCREPANCIES WERE OBSERVED. THIS COMPLAINT IS CONFIRMED. THE RELEVANT DRAWINGS FOR THE DEVICE(S) WERE REVIEWED. NO DRAWING ISSUES OR DISCREPANCIES WERE NOTED. THE DESIGN, MATERIALS, AND FINISHING PROCESSES WERE FOUND TO BE APPROPRIATE FOR THE INTENDED USE OF THESE DEVICES. A REVIEW OF THE DEVICE HISTORY RECORDS WAS UNABLE TO BE COMPLETED SINCE THE PART AND LOT NUMBERS ARE UNKNOWN. FURTHER, THE FOLLOWING CONCOMITANT DEVICES WERE RECEIVED WITH NO COMPLAINTS ALLEGED AGAINST THEM. A VISUAL INSPECTION OF THESE DEVICES FOUND NO PRODUCT DESIGN OR MANUFACTURING RELATED ISSUES. THEREFORE, FURTHER INVESTIGATION IS NOT REQUIRED. PART #: 212.121, LOT #: UNKNOWN, QUANTITY: 2. PART #: 212.119, LOT #: UNKNOWN, QUANTITY: 4. PART #: 212.117, LOT #: UNKNOWN, QUANTITY: 1. PART #: 212.115, LOT #: UNKNOWN, QUANTITY: 1. PART #: 212.110, LOT #: UNKNOWN, QUANTITY: 1. PART #: 02.123.028, LOT #: 9830850, QUANTITY: 1. 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. THIS REPORT IS FOR UNKNOWN TWO, 212.1XX LOCKING SCREWS/UNKNOWN LOT NUMBER. (B)(4). IT WAS REPORTED REVISION SURGERY WAS REQUIRED DUE TO A NON-UNION OF A MID-SHAFT HUMERUS FRACTURE. DURING REVISION SURGERY, FOUR OF THE SCREWS WERE FOUND TO BE BROKEN AT THE HEAD BELOW THE FRACTURE. ALL BROKEN PIECES WERE REMOVED WITHOUT DIFFICULTY. SUBJECT DEVICE HAS NOT BEEN RECEIVED. WITHOUT A LOT NUMBER, THE DEVICE HISTORY RECORD REVIEW AND THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. 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 A PATIENT UNDERWENT REVISION SURGERY FOR A MID-SHAFT HUMERUS NONUNION ON (B)(6) 2016. THE SURGEON REMOVED A 10-HOLE, RIGHT SIDED, 3.5MM LOCKING COMPRESSION PLATE (LCP) PERIARTICULAR PROXIMAL HUMERUS PLATE AND A TOTAL OF 13 SCREWS THAT HAD BEEN IMPLANTED ON (B)(6) 2015. FOUR OF THE SCREWS WERE FOUND TO BE BROKEN BELOW THE FRACTURE. IT WAS NOTED THAT THE FOUR SCREWS HAD BROKEN AT THE HEAD OF EACH SCREW. ALL BROKEN PIECES WERE REMOVED WITHOUT DIFFICULTY. THE PLATE AND REMAINING SCREWS WERE REMOVED INTACT. THERE WAS NO DELAY IN THE SURGERY. THE PATIENT WAS RE-PLATED WITH THE SAME TYPE OF 10-HOLE LCP PERIARTICULAR PROXIMAL HUMERUS PLATE AND AN UNKNOWN NUMBER OF SCREWS. IT WAS REPORTED THAT THE SURGERY WENT AS PLANNED. THIS COMPLAINT IS FOR TWO DEVICES. CONCOMITANT DEVICES: 3.5MM LOCKING COMPRESSION PLATE (LCP) PERIARTICULAR PROXIMAL HUMERUS PLATE, 10 HOLE/235MM/RIGHT (PART #02.123.028, LOT #9830850, QUANTITY 1); LOCKING SCREWS (PART # 212.1XX, LOT #UNKNOWN, QUANTITY UNKNOWN); AND CORTICAL SCREWS (PART #204.8XX, LOT # UNKNOWN, QUANTITY UNKNOWN). IT WAS NOTED THAT THERE WERE A GREATER NUMBER OF LOCKING SCREWS THAN CORTICAL SCREWS. THIS REPORT IS 1 OF 2 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    422594 NAIL, FIXATION, BONE JDS SYNTHES USA

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Required Intervention