BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LAG SCREW, STST GAMMA3® Ø10.5X110MM

    MDR report key: 4222379 · Received November 4, 2014

    Report

    Report Number
    0009610622-2014-00623
    Event Type
    Injury
    Date Received
    November 4, 2014
    Date of Event
    October 8, 2014
    Report Date
    October 8, 2014
    Manufacturer
    STRYKER TRAUMA KIEL
    Product Code
    HSB
    PMA / PMN Number
    K043431
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHARMACIST

    Narratives

    Additional Manufacturer Narrative · 1

    DEFICIENCIES IN MATERIAL OR MANUFACTURING OF THE RETURNED LAG SCREW WERE NOT FOUND. DIMENSIONAL EXAMINATION REVEALED NO DEVIATIONS IN THE RELEVANT UNDAMAGED AREAS OF THE SCREW. THE ITEM REPORTED WAS DOCUMENTED AS FAULTLESS PRIOR TO DISTRIBUTION. REVIEW OF COMPLAINT HISTORY, CAPA DATABASE AND RISK ANALYSIS DID NOT IDENTIFY ANY CONSPICUITY. THE REVIEW OF THE RISK ASSESSMENT FOR THE FAILURE MODE INDICATED THE ISSUE WAS ADDRESSED ADEQUATELY. THERE ARE NO ACTIONS IN PLACE RELATED TO THE REPORTED EVENT FOR THE SUBJECT PRODUCT. NO NON-CONFORMITY WAS IDENTIFIED. THE APPEARANCE OF THE BREAKAGE SURFACES ¿ LINES OF REST, MISSING PLASTIC DEFORMATION ¿ REVEALED THE LAG SCREW BROKE IN FATIGUE MANNER. FURTHERMORE, NONUNION OF THE FEMORAL NECK WAS REPORTED. THE POTENTIAL TIME FRAME FOR NONUNION IN FEMORAL NECK FRACTURES IS DEFINED IN A RANGE UP TO 48 WEEKS. THUS, IT WAS ASSUMED THAT THE LAG SCREW HAD BEEN IMPLANTED FOR 10 MONTHS OR EVEN MORE. IT WAS NOT REPORTED WHAT KIND OF NECK FRACTURE HAD BEEN TREATED. ANYHOW, THE OPERATION TECHNIQUE DEFINES THE TREATMENT OF MEDIAL NECK FRACTURE AS CONTRAINDICATED. BASED ON EXCEEDING BEARING POINTS FOUND ON THE (CONVEX) SURFACE OF THE LAG SCREW AND BASED ON THE MARK OF THE SET SCREW TIP AND IN THE INFERIOR SLIDING FLUTE, IT WAS CONCLUDED THAT SIGNIFICANT LOAD HAD BEEN APPLIED TO THE IMPLANT SYSTEM. FURTHER, THE APPEARANCE IN THE EDGES OF THE OBLONG SLIDING FLUTE SUGGESTED THAT THE TREATMENT HAD SUBSIDED FROM DYNAMIC LOCKING INTO STATIC LOCKING ¿ WHICH COULD BE THE RESULT OF SIGNIFICANT AXIAL LOAD AND / OR INSUFFICIENT REPOSITION. ALSO, THE DEFORMATION OF THE EDGES ON 1 SIDE ONLY, BUT IN OBLIQUE DIRECTION, COULD POINT TO ADDITIONAL TORSIONAL LOAD APPLICATION. IN THIS CASE IT WAS CONCLUDED THAT THE LAG SCREW BROKE IN A FATIGUE MANNER MOST LIKELY CAUSED BY OVERLOAD DUE TO INSUFFICIENT BONE HEALING AND PERMANENT AND / OR HIGH LOAD APPLICATION. IT COULD NOT BE DETERMINED IN WHAT WAY THE PATIENT¿S DATA (HEIGHT, WEIGHT) AND THE PATIENT¿S COMPLIANCE MAY HAVE CONTRIBUTED TO THE EVENT. NEVERTHELESS, IN ABSENCE OF MEDICAL RECORDS / SURGERY REPORTS AND X-RAYS, A MORE PRECISE ROOT CAUSE OF THE REPORTED EVENT COULD NOT BE DETERMINED. WITH AVAILABLE INFORMATION THE EVENT WAS NOT CAUSED BY A DEFICIENCY OF THE DEVICE.

    Additional Manufacturer Narrative · 1

    ONCE THE INVESTIGATION HAS BEEN COMPLETED, ANY ADDITIONAL INFORMATION WILL BE REPORTED IN A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE HOSPITAL, NON-UNION OF THE FEMORAL NECK. FRACTURE OF THE LAG SCREW. FRACTURE OF THE FEMORAL NECK. GAMMA NAIL. NON-UNION. REVISION SURGERY TO BE PLANNED.

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE HOSPITAL, NON-UNION OF THE FEMORAL NECK. FRACTURE OF THE LAG SCREW. FRACTURE OF THE FEMORAL NECK. GAMMA NAIL. NON-UNION. REVISION SURGERY TO BE PLANNED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    708250 LAG SCREW, STST GAMMA3® Ø10.5X110MM ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES HSB STRYKER TRAUMA KIEL K929871

    Patients

    Seq Age Sex Outcome Treatment
    1 90 YR Required Intervention