BEUDAMED
    FDA Adverse Event Injury Summary report: N

    RIB HOOK

    MDR report key: 3092401 · Received May 3, 2013

    Report

    Report Number
    2530088-2013-00774
    Event Type
    Injury
    Date Received
    May 3, 2013
    Date of Event
    March 16, 2013
    Report Date
    April 8, 2013
    Manufacturer
    SYNTHES BRANDYWINE
    Product Code
    MDI
    PMA / PMN Number
    H03009
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. THE INVESTIGATION COULD NOT COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED.

    Additional Manufacturer Narrative · 1

    DEVICE IS USED FOR TREATMENT, NOT DIAGNOSIS. (B)(4). THE PART WAS SCRAPPED AND REMOVED FROM THE SYSTEM. THE COMPLAINT IS NOT CLEAR AS TO WHERE THE FRACTURE OCCURRED THEREFORE THE RELEVANCE OF THIS FEATURE IS INDETERMINATE. (B)(4). THIS CONDITION IS NOT RELEVANT TO THE COMPLAINT BECAUSE IT WAS A DOCUMENTATION OMISSION AND NOT FUNCTIONAL TO THE DEVICE. (B)(4). THIS CONDITION IS NOT RELEVANT TO THE COMPLAINT BECAUSE IT IS COSMETIC AND NOT FUNCTIONAL TO THE DEVICE. (B)(4). THE MATERIAL WAS DISPOSITIONED USE-AS-IS BECAUSE THE OVERSIZE CONDITION CREATED EXTRA MATERIAL FOR REMOVAL AND IT HAD NO EFFECT ON FINISHED PRODUCT. THIS CONDITION IS NOT RELEVANT TO THE COMPLAINT. (B)(4). THE MATERIAL WAS RETURNED TO THE SUPPLIER, REWORKED TO SPECIFICATION, AND RE-INSPECTED FOR CONFORMANCE. THIS CONDITION IS NOT RELEVANT TO THE COMPLAINT BECAUSE IT AFFECTED EXTRA MATERIAL FOR REMOVAL AND HAD NO EFFECT ON FINISHED PRODUCT.

    Additional Manufacturer Narrative · 1

    THIS DEVICE USED FOR TREATMENT AND NOT DIAGNOSIS. WE HAVE FORWARDED THE COMPLAINED DEVICES TO THE RESPONSIBLE PRODUCT DEVELOPMENT ENGINEER FOR EVALUATION, HERE THE FEEDBACK: THE 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 TO 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. THE ARTICLES WERE ANALYZED FOR CONFORMANCE TO PRINT SPECIFICATION, AS WELL AS THE DEVICE HISTORY RECORD WAS RESEARCHED. NO ABNORMAL FINDINGS WERE IDENTIFIED. IS A SINGLE USE DEVICE. PLACEHOLDER.

    Description of Event or Problem · 1

    DEVICE REPORT FROM SYNTHES (B)(4) REPORTS AN EVENT IN COLOMBIA AS FOLLOWS: DURING A PROCEDURE ON (B)(6) 2013 FOR A FRACTURED RIB, A RIB HOOK BROKE. THE SPECIALIST ASSEMBLED THE HOOK IN THE RESPECTIVE FORCEPS AND ATTEMPTED TO IMPLANT OVER THE RIB WHEN THE DEVICE BROKE WITHOUT AN APPARENT CAUSE. NO ADVERSE CONSEQUENCES TO THE PATIENT WERE REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE. THIS IS REPORT 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    195441 RIB HOOK MDI SYNTHES BRANDYWINE 6557418

    Patients

    Seq Age Sex Outcome Treatment
    1 12 YR Required Intervention