BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ROD,FIXATION,INTRAMEDULLARY

    MDR report key: 5605300 · Received April 25, 2016

    Report

    Report Number
    2520274-2016-12175
    Event Type
    Injury
    Date Received
    April 25, 2016
    Report Date
    April 4, 2016
    Manufacturer
    SYNTHES USA
    Product Code
    HSB
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE USED FOR TREATMENT, NOT DIAGNOSIS. KETTLER, M., ET AL (2007). FLEXIBLE INTRAMEDULLARY NAILING FOR STABILIZATION OF DISPLACED MIDSHAFT CLAVICLE FRACTURES TECHNIQUE AND RESULTS IN 87 PATIENTS. ACTA ORTHOPADICA, 3; 424-429/ THIS REPORT IS FOR AN UNKNOWN NAIL (TITANIUM ENDOMEDULLARY), UNKNOWN QUANTITY/UNKNOWN LOT. PART UNKNOWN, UDI IS UNAVAILABLE. (B)(6). (B)(4). THE INVESTIGATION COULD NOT BE COMPLETED AND NO CONCLUSION COULD BE DRAWN AS NO DEVICE WAS RETURNED AND NO LOT NUMBER OR PART NUMBER WERE 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 REPORT IS BEING FILED AFTER THE SUBSEQUENT REVIEW OF THE FOLLOWING ARTICLE: KETTLER, M., ET AL (2007). FLEXIBLE INTRAMEDULLARY NAILING FOR STABILIZATION OF DISPLACED MIDSHAFT CLAVICLE FRACTURES TECHNIQUE AND RESULTS IN 87 PATIENTS. ACTA ORTHOPADICA, 3; 424-429. (B)(6). THE RESULTS OF A NEW MINIMALLY INVASIVE PROCEDURE BASED ON THE USE OF ELASTIC, STABLE INTRAMEDULLARY TITANIUM NAILS WERE ANALYZED. FROM (B)(6) 2001 TO (B)(6) 2005, 95 PATIENTS WITH MID SHAFT FRACTURES WERE TREATED BY EIGHT DIFFERENT SURGEONS USING ELASTIC TITANIUM NAIL (SYNTHES, ((B)(4)) OR DEPUY ((B)(4)). THE ARTICLE DID NOT IDENTIFY WHICH NAILS WERE IMPLANTED IN THE PATIENTS. THE AVERAGE PATIENT AGE WAS 38 YEARS (RANGE 15-74) AND INCLUDED 68 MALES AND 32 FEMALES. OF THE 95 PATIENTS, 8 PATIENTS WERE LOST TO FOLLOW-UP NO EARLY COMPLICATIONS WERE REPORTED IN THESE PATIENTS. EIGHTY-SEVEN PATIENTS WERE EVALUATED AFTER AN AVERAGE FOLLOW-UP PERIOD OF 13 MONTHS (RANGE 6-28). OUTCOME WAS ASSESSED USING DASH SCORE, SHOULDER FUNCTION WAS MEASURED USING SELF-REPORTED CONSTANT SCORE. COMPLICATIONS: TWO (2) PATIENTS, THE NAIL MISSED THE MEDULLARY CANAL OF THE LATERAL FRAGMENT. ONE (1) PATIENT HAD A REVISION TO REINTRODUCE THE NAIL; THE OTHER REFUSED A FURTHER OPERATION AND THE FRACTURE HEALED WITH A SLIGHT MALUNION. ONE (1) PATIENT HAD A NONUNION AFTER PREMATURE IMPLANT REMOVAL. TWO (2) CASES THE PROTRUDING END OF THE NAIL AT THE MEDIAL SIDE CAUSED IRRITATION. THREE (3) PATIENTS HEALED WITH ANGULATIONS OF OVER 30°. FOUR (4) PATIENTS HAD A DISLOCATION OF MORE THAN A SHAFT WIDTH. FOUR (4) PATIENTS HAD HYPERTROPHIC CALLUS FORMATION BUT WITHOUT NEUROLOGICAL SYMPTOMS. TWO (2) PATIENTS COMPLAINED OF PAIN RESULTING FROM LOAD OVER THE FRACTURE. THIS REPORT IS 1 OF 3 FOR (B)(4). THIS REPORT IS FOR UNKNOWN NAIL (TITANIUM ENDOMEDULLARY), UNKNOWN QUANTITY AND LOT NUMBER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    258906 ROD,FIXATION,INTRAMEDULLARY HSB SYNTHES USA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention