BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RIB HOOK

    MDR report key: 2883363 · Received December 21, 2012

    Report

    Report Number
    2530088-2012-01137
    Event Type
    Malfunction
    Date Received
    December 21, 2012
    Date of Event
    November 15, 2012
    Report Date
    November 26, 2012
    Manufacturer
    SYNTHES BRANDYWINE
    Product Code
    MDI
    PMA / PMN Number
    H03009
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE USED FOR TREATMENT AND NOT DIAGNOSIS. PART 04.641.001.1 BODY, LOT 6140265 HAD NON CONFORMANCE U.S. 1016095 GENERATED FOR THE D2 HOLE DIAMETER BEING UNDERSIZE ON 3 OF THE 48 PIECES AT INCOMING INSPECTION. THE PARTS WERE SCRAPPED AND REMOVED FROM THE SYSTEM. THE COMPLAINT IS NOT CLEAR AS TO WHERE THE BREAKAGE OCCURRED ON THE DEVICE THEREFORE THE RELEVANCE OF THIS FEATURE IS INDETERMINATE. PART 04.641.001.2 BARREL, LOT 6139696 HAD NON CONFORMANCE US1020023 GENERATED FOR THE L6 WALL THICKNESS BEING UNDERSIZE ON 18 OF 284 PIECES AT INCOMING INSPECTION. THE PARTS WERE SCRAPPED AND REMOVED FROM THE SYSTEM. THE COMPLAINT IS NOT CLEAR AS TO WHERE THE BREAKAGE OCCURRED ON THE DEVICE THEREFORE THE RELEVANCE OF THIS FEATURE IS INDETERMINATE. RAW MATERIAL PART 21039 HAD NCR US1027751 GENERATED FOR MACHINEABILITY ISSUES. THE MATERIAL MET SPECIFICATIONS AND WAS DISPOSITIONED AS CONFORMS. THIS CONDITION IS NOT RELEVANT TO THE COMPLAINT. THERE WERE NO OTHER ABNORMALITIES OBSERVED DURING THE DHR REVIEW. THE INVESTIGATION IS ONGOING.

    Additional Manufacturer Narrative · 1

    THIS DEVICE IS USED FOR TREATMENT, NOT DIAGNOSIS. VISUAL INSPECTION HAS GIVEN US THE FOLLOWING HINTS, WE DO SUPPOSE THAT THE RIB HOOK AND THE RIB HOOK CAP WERE NOT ALIGNED WHEN MATING THESE TWO PARTS - TOO HIGH FORCES. MOST PROBABLY, THE SURGEON APPLIED TOO MUCH MECHANICAL FORCE ON BOTH PARTS WHEN TRYING TO GET THEM ALIGNED ACCORDINGLY. IDEALLY, THE SURGEON SHOULD HAVE ROTATED THE RIB HOOK CAP DISTALLY TO MATE WITH THE RIB HOOK. IN ADDITION, THE ANATOMY OF THE PATIENT MIGHT HAVE BEEN DIFFICULT WHEN REPLACING VEPTR WITH VEPTR II COMPONENTS. THE ARTICLES WERE ANALYZED FOR CONFORMANCE TO PRINT SPECIFICATION, AS WELL AS THE DEVICE HISTORY RECORD WAS RESEARCHED. NO ABNORMAL FINDINGS WERE IDENTIFIED.

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT NOT FOR DIAGNOSIS. DEVICE HISTORY RECORD REVIEW HAS BEEN REQUESTED. NO CONCLUSION COULD BE DRAWN AS DEVICE IS ENTERING THE INVESTIGATION PROCESS. PLACEHOLDER.

    Description of Event or Problem · 1

    A DEVICE REPORT RECEIVED FROM THE EU FOR AN INCIDENT THAT OCCURRED IN (B)(6) REPORTED TWO RIB HOOKS BROKE INTRA OPERATIVELY. AS THE SURGEON WAS PERFORMING A PLANNED REVISION, TWO DISTAL RIB HOOKS BROKE DURING IMPLANTATION AS THE CRANIAL AND CAUDAL HOOKS WERE ALIGNED. AN ALTERNATE DEVICE WAS PLACED AND THE PROCEDURE WAS COMPLETED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RIB HOOK RIB HOOK MDI SYNTHES BRANDYWINE 6353541

    Patients

    Seq Age Sex Outcome Treatment
    1 5 YR