BEUDAMED
    FDA Adverse Event Death Summary report: N

    SUPRACONDYLAR NAIL T2 SCN Ø10X300MM

    MDR report key: 5752690 · Received June 27, 2016

    Report

    Report Number
    0009610622-2016-00309
    Event Type
    Death
    Date Received
    June 27, 2016
    Date of Event
    April 19, 2016
    Report Date
    June 3, 2016
    Manufacturer
    STRYKER TRAUMA KIEL
    Product Code
    HSB
    PMA / PMN Number
    K023267
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    REFERRING TO THE PRODUCT INQUIRY THE SUPRACONDYLAR NAIL T2 SCN Ø10X300MM IS CONSIDERED THE PRIMARY PRODUCT. NO FURTHER ASSOCIATED PRODUCTS WERE REPORTED. A REVIEW OF THE DEVICE HISTORY RECORDS OF THE NAIL REPORTED REVEALED NO DISCREPANCIES. THE ITEM WAS DOCUMENTED FAULTLESS PRIOR TO DISTRIBUTION. ACCORDING TO INFORMATION RECEIVED THE REPORTED NAIL IS NOT AVAILABLE TO STRYKER. NO PRODUCT WAS COMPLAINED. THE ISSUE IS ABOUT THE DEATH OF A PATIENT TWO DAYS AFTER SURGERY, ALLEGEDLY DUE TO PULMONARY EMBOLISM. ON REQUEST IT WAS CONFIRMED THAT ¿THE T2 NAIL IS NOT SUSPECTED TO HAVE CAUSED THE EVENT¿. THIS IS SUPPORTED BY THE MEDICAL OPINION OF A CONSULTANT HCP; HIS COMMENTS UPON REVIEW OF THE AVAILABLE INFORMATION: PULMONARY EMBOLISM IS A TYPICAL UNSPECIFIC LIFE-THREATENING COMPLICATION AFTER SEVERE BONE INJURIES, MAINLY IN THE LOWER EXTREMITY. STABLE INTERNAL FIXATION ALLOWING FOR EARLY POSTOPERATIVE EXERCISES AND ACTIVE MOVEMENTS OF ADJACENT JOINTS REDUCES THE RISK OF POSTOPERATIVE VENOUS THROMBOSIS AND PULMONARY EMBOLISM BY ACTIVATION OF THE MUSCLE PUMP MECHANISM, BUT HAS NO IMPACT ON THE RISK OF INTRAOPERATIVE PULMONARY EMBOLISM. THE EVENT IS RELATED TO THE SEVERE TRAUMA AND POSSIBLY TO THE SURGICAL PROCEDURE, BUT THERE IS NO DIRECT CAUSAL RELATIONSHIP BETWEEN THE DEVICE (INTRAMEDULLARY NAIL) AND THE EVENT (PULMONARY EMBOLISM). FURTHERMORE, THERE IS NO CLEAR EVIDENCE THAT THERE WAS A PULMONARY EMBOLISM. THE SAME SYMPTOMS MAY BE CAUSED BY FAT EMBOLISM. SINCE NO PRODUCT ISSUES WERE REPORTED AND BASED ON THE ABOVE STATEMENTS, REVIEW OF THE COMPLAINT HISTORY, LABELLING, NC/CAPA HISTORY AND RISK ASSESSMENT WERE DEEMED DISPENSABLE IN THIS CASE. EVALUATION REVEALED THAT THE ROOT CAUSE OF THE EVENT IS NOT DEVICE RELATED. NO NON-CONFORMITY WAS IDENTIFIED.

    Additional Manufacturer Narrative · 1

    DEVICE WILL NOT BE RETURNED. IF ADDITIONAL INFORMATION BECOMES AVAILABLE IT WILL BE PROVIDED ON A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT T2 SCN LONG SURGERY WAS PERFORMED WITHOUT AN ANESTHESIOLOGIST ON (B)(6) 2016. WHEN THE DISTAL SCREWS INSERTION HAS BEEN COMPLETED, THE PATIENT HAS A SUDDEN CHANGE. THE SURGERY HAS BEEN INTERRUPTED, THE INTUBATION AND THE CARDIAC MASSAGE WERE PERFORMED. THE PATIENT DIED TWO DAYS LATER.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT T2 SCN LONG SURGERY WAS PERFORMED WITHOUT AN ANESTHESIOLOGIST ON (B)(6) 2016. WHEN THE DISTAL SCREWS INSERTION HAS BEEN COMPLETED, THE PATIENT HAS A SUDDEN CHANGE. THE SURGERY HAS BEEN INTERRUPTED, THE INTUBATION AND THE CARDIAC MASSAGE WERE PERFORMED. THE PATIENT DIED TWO DAYS LATER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    405748 SUPRACONDYLAR NAIL T2 SCN Ø10X300MM ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES HSB STRYKER TRAUMA KIEL K08F086

    Patients

    Seq Age Sex Outcome Treatment
    1 Death