BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RETRACTOR FRAME CRANIAL/CAUDAL

    MDR report key: 7794764 · Received August 17, 2018

    Report

    Report Number
    2939274-2018-53369
    Event Type
    Malfunction
    Date Received
    August 17, 2018
    Report Date
    August 1, 2018
    Manufacturer
    WRIGHTS LANE SYNTHES USA PRODUCTS LLC
    Product Code
    GAD
    UDI-DI
    10705034715360
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    DEPUY SYNTHES IS SUBMITTING THIS REPORT PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH DEPUY SYNTHES HAS NOT BEEN ABLE TO INVESTIGATE OR VERIFY PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY FDA, DEPUY SYNTHES OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE DEVICE, DEPUY SYNTHES, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. NO KNOWN PATIENT INVOLVEMENT REPORTED. THE DEVICE WAS RECEIVED AND THE PRODUCT EVALUATION IS IN PROGRESS. NO CONCLUSION CAN BE DRAWN. ADDITIONALLY, DEVICE HISTORY RECORDS REVIEW HAS BEEN REQUESTED. 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 · 0

    IT WAS FURTHER REPORTED THAT THERE WAS NO KNOWN PATIENT INVOLVEMENT AND THERE WAS NO DISRUPTION OF SURGERY HAPPENED.

    Additional Manufacturer Narrative · 1

    PATIENT INFORMATION WAS NOT PROVIDED FOR REPORTING. DATE OF EVENT IS UNKNOWN. DEVICE IS AN INSTRUMENT AND IS NOT IMPLANTED / EXPLANTED. DEVICE IS EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION BUT HAS NOT BEEN RECEIVED YET. REPORTER IS SYNTHES SALES REPRESENTATIVE. DEVICE EVALUATION/INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN AS PRODUCT WAS NOT RETURNED TO MANUFACTURER. ADDITIONALLY, DEVICE HISTORY RECORDS REVIEW COULD NOT BE COMPLETED WITHOUT LOT NUMBER. 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

    DEVICE HISTORY RECORDS REVIEW WAS COMPLETED FOR PART# 03.615.100, LOT# T951344. MANUFACTURING LOCATION: (B)(4), RELEASE TO WAREHOUSE DATE: DEC 10, 2010. REVIEW OF THE DEVICE HISTORY RECORDS SHOWED THAT THERE WERE NO ISSUES DURING THE MANUFACTURE OF THE PRODUCT THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. PRODUCT INVESTIGATION WAS COMPLETED. THE IMPLANT WAS RECEIVED WITH THE REPORTED CONDITION OF ¿DEVICE INTERACTION (2+ DEVICES) UNABLE TO ASSEMBLE: RM¿ INVESTIGATION FLOW DEVICE INTERACTION/FUNCTIONAL WAS PERFORMED. THE RETURNED IMPLANT WAS VISUALLY INSPECTED, AND NO DAMAGE WAS SEEN ON ANY COMPONENT OF THE DEVICE. THERE WERE NO DENTS/SCRATCHES ON THE RATCHETING PORTION OF THE INSTRUMENT. A FUNCTIONAL TEST WAS DONE, AND THE DEVICE FUNCTIONED AS INTENDED. ALL COMPONENTS MOVED FREELY AND HELD IN PLACE WHEN LOCKED APPROPRIATELY. THE RECEIVED CONDITION DOES NOT AGREES WITH THE COMPLAINT DESCRIPTION. THE COMPLAINT CONDITION COULD NOT BE REPLICATED, AND NO ISSUES WERE DETECTED. THE COMPLAINT COULD NOT BE CONFIRMED. DURING THE INVESTIGATION, NO PRODUCT DESIGN OR MANUFACTURING ISSUES WERE OBSERVED THAT MAY HAVE CONTRIBUTED TO THE COMPLAINT CONDITION. BASED ON THE INVESTIGATION FINDINGS, IT HAS BEEN DETERMINED THAT NO CORRECTIVE AND/OR PREVENTATIVE ACTION IS PROPOSED. 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

    IT WAS REPORTED THAT THE RETRACTOR FRAME CRANIAL/CAUDAL IS NOT HOLDING. IT IS UNKNOWN WHEN AND HOW THE MALFUNCTION WAS DISCOVERED. IT IS UNKNOWN IF THERE WAS PATIENT AND PROCEDURAL INVOLVEMENT. THIS REPORT IS FOR ONE (1) RETRACTOR FRAME CRANIAL/CAUDAL. THIS IS REPORT 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    634891 RETRACTOR FRAME CRANIAL/CAUDAL RETRACTOR GAD WRIGHTS LANE SYNTHES USA PRODUCTS LLC T951344 10705034715360

    Patients

    Seq Age Sex Outcome Treatment
    1