BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TI DHS®/DCS® COMPRESSION SCREW 36MM

    MDR report key: 4623228 · Received March 23, 2015

    Report

    Report Number
    3009450884-2015-10024
    Event Type
    Injury
    Date Received
    March 23, 2015
    Report Date
    March 10, 2015
    Manufacturer
    SYNTHES GRENCHEN
    Product Code
    JDO
    PMA / PMN Number
    PK953607
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A PRODUCT INVESTIGATION WAS COMPLETED: WE HAVE RECEIVED THESE ARTICLES 04.224.224, 480.990S, 480.900, 414.834 BACK IN AN INTACT CONDITION. OUR INVESTIGATION OF THE COMPLAINED IMPLANTS HAS SHOWN: THAT THE ARTICLES 414.838, 414.838, 414.836 WE HAVE RECEIVED BACK BROKEN / BADLY DAMAGED AND ONE WITH BONE ADHERED. ALSO THERE ARE SCRATCHES ON THE SURFACE AND DEFORMATION AT SHANK AND AT THE THREAD VISIBLE. THIS INDICATES CONTACT WITH THE PLATE. WE ARE NOT ABLE TO DETERMINE THE EXACT REASON FOR THIS REPORTED PROBLEM, BUT IT IS LIKELY THAT DURING THE OPERATION AN APPLICATION ERROR MAY HAVE TAKEN PLACE OR THAT AN OVERLOADING SITUATION OR STRONG BODY / BONE MOVEMENT FROM THE PATIENT LED TO THESE BREAKAGES OF THE SCREWS. THE MANUFACTURING RECORDS WERE REVIEWED THE IMPLANTS WERE MANUFACTURED IN (04.224.224, 8612986, SEPTEMBER 2013; 480.990S, 8753610, DECEMBER 2013; 480.900, 8903215, MAY 2014; 414.834, 8633444, SEPTEMBER 2013; 414.838, 2452548, JANUARY 2009; 414.838, 9019617, JUNE 2014; 414.836, 8590497, AUGUST 2013), PRODUCED TO SPECIFICATION AND MET ALL RELEASE CRITERIA. NO PRODUCT FAULT COULD BE DETECTED. 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

    THE INITIAL COMPLAINT WAS REVIEWED AND FOUND NOT REPORTABLE. THERE IS NO DOCUMENTATION OF THIS EVENT CAUSING OR CONTRIBUTING TO AN INJURY. THERE IS NO DOCUMENTATION OF FRAGMENTATION OF THE COMPLAINT DEVICE. THERE IS NO DOCUMENTATION OF THIS EVENT CAUSING OR CONTRIBUTING TO A SURGICAL DELAY. RATIONALE: NOT LIKELY TO RESULT IN PATIENT HARM OR THE NEED FOR ADDITIONAL MEDICAL OR SURGICAL INTERVENTION, AND NO HISTORY OF A PREVIOUS REPORT OF SERIOUS INJURY OR DEATH. 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: 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.

    Additional Manufacturer Narrative · 1

    EVENT DATE: UNKNOWN. (B)(4). THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. A REVIEW OF THE DEVICE HISTORY RECORDS WAS COMPLETED: THIS COMPLAINT IS ASSESSED AS NOT RELATED TO STERILIZATION. THUS, THE DOCUMENTS FOR THE CORRESPONDING NON STERILE WERE REVIEWED WITH THE FOLLOWING RESULT: NO NON-CONFORMANCE REPORTS WERE GENERATED DURING PRODUCTION. REVIEW OF THE DEVICE HISTORY RECORD 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.

    Description of Event or Problem · 1

    THIS IS REPORT 5 OF 5 FOR (B)(4).

    Description of Event or Problem · 1

    DEVICE REPORT FROM SYNTHES (B)(4) REPORTS AN EVENT IN (B)(6) AS FOLLOWS: THE REPORTED THREE CORTEX SCREWS WERE FOUND BROKEN POST-OPERATIVELY. THE REPORTED PRODUCTS WERE USED FOR FEMORAL TROCHANTERIC FRACTURE. THE INITIAL IMPLANT DATE WAS (B)(6), 2014. THE SURGERY OF EXPLANT AND RE-FIXATION WITH ANOTHER MANUFACTURING¿S PRODUCTS WAS PERFORMED ON (B)(6), 2015. VARUS DEFORMITY WAS CONFIRMED AFTER THE INITIAL SURGERY. IT WAS REPORTED THE PLATE WAS NOT BROKEN. THIS IS REPORT 3 OF 3 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    193142 TI DHS®/DCS® COMPRESSION SCREW 36MM APPLIANCE, FIXATION DEVICE, PROXIMAL FEMUR JDO SYNTHES GRENCHEN 8753610

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention