BEUDAMED
    FDA Adverse Event Injury Summary report: N

    O-RING F/392.901

    MDR report key: 5485752 · Received March 8, 2016

    Report

    Report Number
    2520274-2016-11525
    Event Type
    Injury
    Date Received
    March 8, 2016
    Date of Event
    January 20, 2016
    Report Date
    February 8, 2016
    Manufacturer
    SYNTHES (USA)
    Product Code
    HST
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    MANUFACTURING INVESTIGATION EVALUATION: ONE (1) ARTICLE OF CENTRAL BODY F/MEF MAX-L 437 MIN-L 287 (PART 392.901) WAS RECEIVED FOR MANUFACTURING INVESTIGATION. THE ARTICLE IS IN A USED CONDITION WITH VISIBLE MARKS OF USE AT THE ANODIZED END PARTS. THE DEPARTMENT RESPONSIBLE FOR THE ASSEMBLY AND TESTING OF THE CENTRAL BODY F/MEF HAS EVALUATED THE COMPLAINED ISSUE. THE INVESTIGATION WAS TO DETERMINE IF THE ISSUE, AS IT WAS REPORTED, COULD BE FOUND WHEN MANIPULATING THE MOVABLE PARTS. THE EXACT MALFUNCTION COULD NOT BE DUPLICATED DURING THE TESTS. HOWEVER, THE FOLLOWING ANOMALIES WERE FOUND: THE SUBCOMPONENT DYNAMIZATION END PIECE (PART 392.901.013) WAS MAKING NOISE AND AN ABNORMAL TYPE OF RESISTANCE WAS FELT WHEN TURNING ON IT. ALSO, DAMAGES ON THE O-RING SEAL, RESIDUES ON THE OUTER THREAD, AND DISCOLORATION OF THE WRENCH SURFACE WERE OBSERVED. IT IS LIKELY THAT THE RESIDUE CAME INTO THE MECHANISM OF THE DYNAMIZATION END PIECE AS A RESULT OF INSUFFICIENT CLEANING AND REPROCESSING. NO MANUFACTURING RELATED ISSUES WERE IDENTIFIED AND/OR CONFIRMED. 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

    (B)(4). DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. ADDITIONAL NARRATIVE: PATIENT AGE: UNKNOWN. PATIENT AGE WAS REPORTED AS (B)(6). PATIENT WEIGHT WAS NOT AVAILABLE FOR REPORTING. PARTIAL UDI# (B)(4); LOT NUMBER UNKNOWN. THE EXACT DATE OF IMPLANT IS UNKNOWN AND WAS APPROXIMATELY(B)(6) 2016. (B)(6). THIS DEVICE WAS RECEIVED ON (B)(4) 2016 AND ADDED TO THE COMPLAINT SINCE IT IS NOT KNOWN WHICH OF THE TWO O-RING DEVICES HAD THE REPORTED PROBLEM. DEVICE IS NOT DISTRIBUTED IN THE UNITED STATES, BUT IS SIMILAR TO DEVICE MARKETED IN THE USA. WITHOUT A LOT NUMBER THE DEVICE HISTORY RECORDS REVIEW COULD NOT BE COMPLETED. THE SUBJECT DEVICE HAS BEEN RECEIVED AND IS CURRENTLY IN THE EVALUATION PROCESS. MFR DATE: UNKNOWN. 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

    DEVICE REPORT FROM SYNTHES (B)(4) REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT THE CENTRAL BODY FOR THE MONOLATERAL EXTERNAL FIXATION SYSTEM FOR TRAUMA AND ORTHOPEDICS (MEFISTO) DOES NOT ELONGATE THE AREA WHERE THE DISK AND THE DYNAMIZATION PARTS ARE. THE EXTERNAL FIXATOR (MEFISTO SYSTEM) WAS PLACED SIX DAYS PRIOR TO (B)(6) 2016. THE REPORTED ISSUE WAS OBSERVED ON (B)(6) 2016; ON THE SIXTH DAY OF THE ELONGATION TREATMENT. THE SURGEON TURNED ON THE DISC HOLE TO TEST THE ELONGATION FUNCTION BUT IT APPEARED THAT THE SYSTEM (O-RING) IS BLOCKED AND CANNOT ROTATE. THE MEFISTO SYSTEM WAS REMOVED ON (B)(6) 2016 DUE TO THE CENTRAL BODY'S INABILITY TO PERFORM ELONGATION. THIS REPORT IS 3 OF 3 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    142089 O-RING F/392.901 TRACTION, APPARATUS, NON-POWERED HST SYNTHES (USA)

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention