BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RETRACTOR FRAME CRANIAL/CAUDAL

    MDR report key: 5510469 · Received March 18, 2016

    Report

    Report Number
    9680938-2016-10036
    Event Type
    Malfunction
    Date Received
    March 18, 2016
    Date of Event
    March 3, 2016
    Report Date
    March 3, 2016
    Manufacturer
    SYNTHES TUTTLINGEN
    Product Code
    GAD
    PMA / PMN Number
    PEXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL NARRATIVE: IT IS UNKNOWN IF THERE WAS PATIENT INVOLVEMENT. EVENT DATE: UNKNOWN. DEVICE IS AN INSTRUMENT AND IS NOT IMPLANTED/EXPLANTED. MANUFACTURING DATE: DECEMBER 10, 2010. REVIEW OF THE DEVICE HISTORY RECORDS SHOWED THAT THERE WERE NO ISSUES AT THE TIME OF MANUFACTURING OF THIS DEVICE THAT WOULD CONTRIBUTE TO THE ISSUE OUTLINED IN THIS COMPLAINT. ALL PARTS WERE CHECKED FOR FUNCTION AT THE FINAL INSPECTION. THE RAW MATERIAL IS CORRESPONDING TO THE SPECIFICATIONS. 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

    PRODUCT INVESTIGATION SUMMARY: ONE (1) RETRACTOR FRAME (PART 03.615.100 / LOT T951344) WAS RETURNED WITH A COMPLAINT STATING THAT THE RETRACTOR FRAME LOCKING MECHANISM WAS SLIPPING. UPON INSPECTION OF THE RETURNED DEVICE, THE COMPLAINT WAS ABLE TO BE CONFIRMED AS THE FRAME WAS ABLE TO BE SLID APART EVEN WHILE LOCKED. THE EDGES OF THE TOOTH WELL ON THE SLIDING ARM EXHIBITED WEAR. IT WAS ALSO NOTED THAT THE FIXED ARM WAS NOT ABLE TO BE LOCKED IN PLACE TO PREVENT ROTATION. THE RETURNED RETRACTOR IS PART OF THE INSIGHT ACCESS RETRACTOR SYSTEM. REUSABLE RETRACTOR BLADES ARE ATTACHED TO THE RETRACTOR FRAME AND THE ENSEMBLE IS USED TO KEEP THE EDGES OF THE SURGICAL INCISION SEPARATED SUFFICIENTLY FOR THE SURGEON TO BE ABLE TO WORK ON THE SURGICAL AREA WITHOUT SOFT TISSUE DISTURBANCE. THE RETRACTOR FRAME USES A RACK AND PINION SYSTEM TO CONVERT ROTATIONAL MOTION INTO LINEAR MOTION BY TORQUEING THE KNOB. A RATCHET LOCKS THE GEAR IN POSITION TO HOLD THE POSITION. A SPRING IS ATTACHED TO THE RATCHET TO HOLD THE RATCHET IN A LOCKED OR UNLOCKED POSITION. ADDITIONALLY, THERE ARE INTERNAL LOCKING MECHANISMS ON THE FRAME USED TO SECURE THE LEFT AND RIGHT RETRACTOR BLADE ARMS IN THE DESIRED POSITIONS TO MOST EFFECTIVELY PREVENT SURROUNDING SOFT TISSUE FROM DISTURBING THE SURGICAL PROCEDURE. THE RELEVANT PRODUCT DRAWINGS WERE REVIEWED DURING THE INVESTIGATION AND THE DESIGN HISTORY WAS FOUND TO NOT IMPACT THE COMPLAINT CONDITION. DURING THE INVESTIGATION, NO PRODUCT DESIGN ISSUES OR DISCREPANCIES WERE OBSERVED THAT MAY HAVE CONTRIBUTED TO THE COMPLAINT CONDITION. THE RETURNED PART WAS DETERMINED TO BE SUITABLE FOR THE INTENDED USE WHEN EMPLOYED AND MAINTAINED AS RECOMMENDED. A DEVICE HISTORY REVIEW IDENTIFIED TWO (2) NON-CONFORMANCE REPORTS, BUT BOTH WERE DISPOSITIONED AS ¿USE AS IS¿ AND HAVE NO BEARING ON THIS COMPLAINT CONDITION. THE FRAME WAS RECEIVED WITH WEAR REFLECTIVE OF ROUTINE USAGE. THE FRAME WAS ABLE TO BE SLID APART EVEN WHILE LOCKED AND THE EDGES OF THE TOOTH WELL ON THE SLIDING ARM EXHIBITED SIGNIFICANT WEAR. IT WAS ALSO NOTED THAT THE FIXED ARM WAS NOT ABLE TO BE LOCKED IN PLACE TO PREVENT ROTATION. ALTHOUGH THERE IS INSUFFICIENT INFORMATION TO DETERMINE THE TRUE ROOT CAUSE, IT IS POSSIBLE THAT THE ROOT CAUSE OF THE COMPLAINT CONDITION WAS TOO MUCH FORCE APPLIED TO THE TOOTH OF THE SADDLE CAUSING IT TO WEAR OR BREAK, WHICH PREVENTED THE ARM FROM ENGAGING AS INTENDED. NO DESIGN ISSUES WERE NOTED. 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

    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 LOCKING MECHANISM IS SLIPPING. THIS IS REPORT 1 OF 1 FOR (B)(4).

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED ON (B)(6) 2016: IT WAS REPORTED THAT THE RETRACTOR FRAME LOCKING MECHANISM IS SLIPPING. THE RETRACTOR SLIPPED UPON INITIAL SET UP FOR A CASE ON (B)(6) 2016. A BACK UP INSTRUMENT WAS USED AND THE PROCEDURE CONTINUED AS PLANNED WITHOUT ANY ISSUES. A SURGICAL DELAY OF APPROXIMATELY FOUR MINUTES WAS REPORTED. THERE WAS NO REPORTED PATIENT HARM. THIS REPORT IS 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    165905 RETRACTOR FRAME CRANIAL/CAUDAL RETRACTOR GAD SYNTHES TUTTLINGEN T951344

    Patients

    Seq Age Sex Outcome Treatment
    1