BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NAIL,FIXATION, BONE

    MDR report key: 5401978 · Received February 1, 2016

    Report

    Report Number
    2520274-2016-10616
    Event Type
    Injury
    Date Received
    February 1, 2016
    Report Date
    January 19, 2016
    Manufacturer
    SYNTHES USA
    Product Code
    JDS
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED AS TREATMENT, NOT DIAGNOSIS. RICCI WM, O¿BOYLE M, BORRELLI J, BELLABARBA C AND SANDERS R. (2001) ¿FRACTURES OF THE PROXIMAL THIRD OF THE TIBIAL SHAFT TREATED WITH INTRAMEDULLARY NAILS AND BLOCKING SCREWS¿ JOURNAL OF ORTHOPAEDIC TRAUMA VOL. 15, NO. 4, PP. 264¿270; 2001, PHILADELPHIA (US). THIS REPORT IS FOR UNKNOWN TIBIAL NAILS AND SCREWS, UNKNOWN QUANTITY, UNKNOWN LOT. UDI #: UNKNOWN PART NUMBER, UDI UNAVAILABLE. (B)(4) OSTEOMYELITIS. THE INVESTIGATION COULD NOT BE COMPLETED AND NO CONCLUSION COULD BE DRAWN, AS NO DEVICE WAS RETURNED AND NO LOT NUMBER OR PART NUMBER WAS PROVIDED. 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

    THIS COMPLAINT HAS BEEN INITIATED AFTER REVIEW OF THE FOLLOWING ARTICLE: RICCI WM, O'BOYLE M, BORRELLI J, BELLABARBA C AND SANDERS R. (2001) "FRACTURES OF THE PROXIMAL THIRD OF THE TIBIAL SHAFT TREATED WITH INTRAMEDULLARY NAILS AND BLOCKING SCREWS" JOURNAL OF ORTHOPAEDIC TRAUMA VOL. 15, NO. 4, PP. 264-270; 2001, PHILADELPHIA (US) . THE PURPOSE OF THIS ARTICLE WAS TO DESCRIBE THE TECHNIQUE AND RESULTS OF USING BLOCKING SCREWS AND INTRAMEDULLARY NAILS TO TREAT PATIENTS WITH FRACTURES OF THE PROXIMAL THIRD OF THE TIBIAL SHAFT AT A LEVEL I TRAUMA CENTERS. TWELVE CONSECUTIVE PATIENTS TREATED WITH INTRAMEDULLARY NAILING AND BLOCKING SCREWS FOR FRACTURES OF THE PROXIMAL THIRD OF THE TIBIAL SHAFT. PATIENTS WERE TREATED WITH INTRAMEDULLARY NAILS AND BLOCKING SCREWS. THE TITANIUM TIBIAL NAIL (SYNTHES USA, (B)(4)) WAS USED IN SIX PATIENTS. THE RUSSELL-TAYLOR TIBIAL NAIL (SMITH & NEPHEW RICHARDS, INC., (B)(4)) IN FIVE PATIENTS, AND THE AIM TITANIUM TIBIAL NAIL (DEPUY ACE, (B)(4)) WAS USED IN ONE PATIENT. NAILS WERE INSERTED WITHOUT REAMING IN SEVEN PATIENTS AND WITH REAMING IN FIVE. THE ALIGNMENT OF FRACTURES WAS DETERMINED USING STANDARD ANTEROPOSTERIOR AND LATERAL RADIOGRAPHS AFTER SURGERY AND AT EACH FOLLOW-UP EXAMINATION. ONE PATIENT WAS LOST TO FOLLOW-UP. ALL OTHER PATIENTS WERE FOLLOWED AT REGULAR INTERVALS UNTIL UNION OR ESTABLISHMENT OF A NONUNION. CHANGES IN ALIGNMENT AND COMPLICATIONS WERE NOTED. THE RESULTS REPORTED IN THIS ARTICLE WERE POSTOPERATIVELY, ALL PATIENTS HAD LESS THAN 5 DEGREES OF ANGULAR DEFORMITY IN THE PLANES IN WHICH BLOCKING SCREWS WERE USED TO CONTROL ALIGNMENT. ONE PATIENT HAD POSTOPERATIVE MALALIGNMENT (6 DEGREES OF VALGUS), BUT A LATERAL BLOCKING SCREW TO CONTROL VALGUS DEFORMITY WAS NOT USED IN THIS PATIENT. ONE PATIENT WAS LOST TO FOLLOW-UP. ELEVEN PATIENTS WERE FOLLOWED UP TO UNION, ON PATIENT WAS REPORTED TO HAVE PERSISTENT OR ESTABLISHMENT OF A NONUNION. TEN OF ELEVEN PATIENTS MAINTAINED THEIR POSTOPERATIVE FRACTURE ALIGNMENT AT THEIR LAST FOLLOW-UP EXAMINATION (AVERAGE FOLLOW-UP OF THIRTY-THREE WEEKS). ONE PATIENT PROGRESSED FROM 6 DEGREES OF VALGUS IMMEDIATELY AFTER SURGERY TO 10 DEGREES OF VALGUS AT UNION. THIS PATIENT DID NOT HAVE A BLOCKING SCREW TO CONTROL VALGUS ANGULATION. IN CONCLUSION THE LOCKING SCREWS ARE EFFECTIVE TO HELP OBTAIN AND MAINTAIN ALIGNMENT OF FRACTURES OF THE PROXIMAL THIRD OF THE TIBIAL SHAFT TREATED WITH INTRAMEDULLARY NAILS. THIS REPORT IS FOR AN UNKNOWN TITANIUM TIBIAL NAIL AND SCREWS. THIS IS RELATED TO TWO NONUNIONS, AND BOTH OF THESE PATIENTS HAD OPEN FRACTURES. DESPITE RADIOGRAPHIC EVIDENCE OF A NONUNION, ONE OF THESE PATIENTS REFUSED FURTHER OPERATIVE TREATMENT. THE OTHER PATIENT HAD MULTIPLE OPERATIVE PROCEDURES TO TREAT HIS INFECTED NONUNION THAT EVENTUALLY HEALED. ONE PATIENT HAD OSTEOMYELITIS AND ANOTHER ADDITIONAL PATIENT REQUIRED REMOVAL OF PROXIMAL INTERLOCKING SCREWS BECAUSE OF PAIN. THE PART NUMBER AND LOT NUMBERS ARE UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    59864 NAIL,FIXATION, BONE JDS SYNTHES USA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention