BEUDAMED
    FDA Adverse Event Injury Summary report: N

    INSERTION HANDLE FOR MULTILOC HUMERAL NAILING SYSTEM

    MDR report key: 5242430 · Received November 23, 2015

    Report

    Report Number
    3003875359-2015-10493
    Event Type
    Injury
    Date Received
    November 23, 2015
    Date of Event
    November 3, 2015
    Report Date
    November 5, 2015
    Manufacturer
    SYNTHES HAGENDORF
    Product Code
    HSB
    PMA / PMN Number
    PK103002
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PATIENT INFORMATION NOT AVAILABLE FOR REPORTING DEVICE IS AN INSTRUMENT AND IS NOT IMPLANTED/EXPLANTED. COMPLAINANT PART IS EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION, BUT HAS YET TO BE RECEIVED (B)(6). THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. DHR REVIEW ¿ MANUFACTURING LOCATION: (B)(4). MANUFACTURING DATE: 03.MAY.2013. NO NCRS WERE GENERATED DURING PRODUCTION. REVIEW OF THE DEVICE HISTORY RECORD(S) SHOWED THAT THERE WERE NO ISSUES DURING THE MANUFACTURE OF THE PRODUCT THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. DEVICE WAS 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

    ADDITIONAL NARRATIVE: MANUFACTURING INVESTIGATION EVALUATION: RECEIVED ONE (1) ARTICLE OF INSERTION HANDLE FOR MULTILOC HUMERAL NAILING SYSTEM (PART 03.019.006) FOR MANUFACTURING INVESTIGATION. THE WIDTH 4 -0.01/-0.06 (PER DRAWING) IS DAMAGED, BUT STILL MEASURABLE. DURING MANUFACTURING INVESTIGATION, ALL RELEVANT AND SIGNIFICANT CHARACTERISTICS LIKE DIMENSIONS WERE CHECKED AND ADDITIONALLY THE ARTICLE PASSED THE FUNCTIONAL TEST. ALL CHECKED CHARACTERISTICS ARE WITHIN THE SPECIFICATIONS. THERE ARE NO REFERENCES TO THE REPORTED ISSUE. NO MANUFACTURING RELATED ISSUE WAS IDENTIFIED AND/OR CONFIRMED. PRODUCT INVESTIGATION SUMMARY: ONE (1) MULTILOC HUMERAL NAIL (PART 04.018.270 / LOT 5932453) AND ONE (1) INSERTION HANDLE FOR MULTILOC HUMERAL NAIL SYSTEM (PART 03.019.006 / LOT 8318044) WERE RETURNED. THE DEVICES WERE FORWARDED TO THE MANUFACTURER FOR EVALUATION WHERE THE COMPLAINT CONDITION COULD NOT BE CONFIRMED. AN EXACT ROOT CAUSE COULD NOT BE DETERMINED; HOWEVER, IT IS LIKELY THAT FAR TOO MUCH MECHANICAL FORCE CAUSED THE DAMAGE. DURING MANUFACTURING INVESTIGATION, ALL RELEVANT AND SIGNIFICANT CHARACTERISTICS SUCH AS DIMENSIONS WERE CHECKED AND ADDITIONALLY THE ARTICLE PASSED THE FUNCTIONAL TEST. ALL CHECKED CHARACTERISTICS ARE WITHIN THE SPECIFICATIONS. THERE ARE NO REFERENCES TO THE REPORTED ISSUE. NO MANUFACTURING RELATED ISSUE WAS IDENTIFIED AND/OR CONFIRMED. DURING THE INVESTIGATION NO PRODUCT DESIGN ISSUES OR DISCREPANCIES WERE OBSERVED THAT MAY HAVE CONTRIBUTED TO THE COMPLAINT CONDITION. 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

    THE DEVICE WAS RECEIVED, THE INVESTIGATION COULD NOT BE COMPLETED, AND NO CONCLUSION COULD BE DRAWN, AS PRODUCT IS ENTERING THE COMPLAINT SYSTEM.DEVICE WAS 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.

    Description of Event or Problem · 1

    DEVICE REPORT FROM SYNTHES EU REPORTS AN EVENT IN (B)(6) AS FOLLOWS: DURING SURGERY, THE SURGEON HAD A DIFFICULT TIME ADVANCING THE NAIL DISTALLY IN THE PATIENT. THE SURGEON EVENTUALLY MANAGED TO INSERT THE NAIL, BUT WHEN THE SURGEON WAS ABOUT TO INSERT THE PROXIMAL SCREW, THE GUIDE ASSEMBLY DID NOT MATCH THE HOLE IN THE NAIL. THE NAIL BEGAN TO LOOSEN AND POSSIBLY DAMAGE, SO THE SURGEON CHANGED THE NAIL TO A SMALLER DIAMETER. DUE TO THIS INCIDENT, THE SURGERY WAS PROLONGED 1 HOUR. THIS IS REPORT 2 OF 5 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    774476 INSERTION HANDLE FOR MULTILOC HUMERAL NAILING SYSTEM ROD,FIXATION,INTRAMEDULLARY HSB SYNTHES HAGENDORF 8318044

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention