BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RIB HOOK

    MDR report key: 2891541 · Received December 31, 2012

    Report

    Report Number
    2530088-2012-01156
    Event Type
    Malfunction
    Date Received
    December 31, 2012
    Report Date
    December 2, 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 WAS USED FOR TREATMENT, NOT DIAGNOSIS. SUBJECT DEVICE HAS BEEN RECEIVED AND IS CURRENTLY IN THE EVALUATION PROCESS. INVESTIGATION IS ON GOING; NO CONCLUSION COULD BE DRAWN.

    Additional Manufacturer Narrative · 1

    DEVICE USED FOR TREATMENT AND NOT DIAGNOSIS. PART 04.641.001.2 BARREL, LOT 6346862 HAD NCR US1047381 GENERATED FOR D1 HOLE DIAMETER BEING UNDERSIZE ON 1 OF 100 PIECES AT INCOMING INSPECTION. THE PART WAS 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, LOT 5327283 HAD NON CONFORMANCE U.S.1027751 GENERATED FOR MACHINEABILITY ISSUES. THE MATERIAL MET SPECIFICATIONS AND WAS DISPOSITIONED AS CONFORMS. THIS CONDITION IS NOT RELEVANT TO THE COMPLAINT. RAW MATERIAL PART 24109, LOT 6346865 HAD NON CONFORMANCE US1015234 GENERATED FOR L1 WIDTH BEING OVERSIZE AND L2 HEIGHT BEING OVERSIZE. THE RAW MATERIAL WAS RETURNED TO THE SUPPLIER FOR REWORK. THE MATERIAL WAS RETURNED, RE-INSPECTED AND DETERMINED TO BE WITHIN SPECIFICATION. THIS CONDITION IS NOT RELEVANT TO THE COMPLAINT. RAW MATERIAL PART 24019, LOT 6235417 HAD NON CONFORMANCE U.S.1015950 GENERATED FOR L THICKNESS BEING O/S. 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. THERE WERE NO OTHER ABNORMALITIES OBSERVED DURING THE DHR REVIEW. THE MEASURABLE DIMENSIONS WERE CHECKED AND FOUND TO BE IN COMPLIANCE WITH THE TECHNICAL DRAWINGS AND AO ASIF SPECIFICATION. THE EXAMINATION OF THE RAW MATERIAL TESTING CERTIFICATE AND THE MANUFACTURING PAPERS SHOWED NO DEVIATIONS REGARDING MATERIAL ANALYSIS, STRENGTH AND STRUCTURAL STABILITY. THE VALUES WERE IN COMPLIANCE WITH AO ASIF SPECIFICATION AND WITH THE INTERNATIONAL STANDARD ISO 5832-11. UNFORTUNATELY, THE INFORMATION GIVEN DID NOT PROVIDE SUFFICIENT EVIDENCE FOR AN EXACT DETERMINATION OF THE FAILURE REASON. NEVERTHELESS, A MANUFACTURING RELATED CONDITION CAN BE EXCLUDED AND WE CAN ONLY ASSUME THAT THE RIB HOOK BROKE DUE TO AN UNINTENDED HIGH BENDING MOMENT.

    Description of Event or Problem · 1

    DEVICE REPORT FROM SYNTHES (B)(4) REPORTS AN EVENT IN (B)(6) AS FOLLOWS: DURING A SURGERY ON (B)(6) 2012 A RIB HOOK BROKE WHILE IT WAS BEING INSERTED WITH INSTRUMENT. THIS IS 1 OF 1 REPORT FOR THIS EVENT.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 8 YR Required Intervention