BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RETRACTOR FRAME CRANIAL/CAUDAL

    MDR report key: 5647420 · Received May 11, 2016

    Report

    Report Number
    9680938-2016-10069
    Event Type
    Malfunction
    Date Received
    May 11, 2016
    Date of Event
    April 9, 2016
    Report Date
    April 9, 2016
    Manufacturer
    SYNTHES TUTTLINGEN
    Product Code
    GAD
    PMA / PMN Number
    PEXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. INFORMATION NOT AVAILABLE FOR REPORTING. DEVICE IS AN INSTRUMENT AND IS NOT IMPLANTED/EXPLANTED. SUBJECT DEVICE HAS BEEN RECEIVED AND IS CURRENTLY IN THE EVALUATION PROCESS. INVESTIGATION IS ONGOING; NO CONCLUSION COULD BE DRAWN AS PRODUCT IS ENTERING THE COMPLAINT SYSTEM. DEVICE HISTORY RECORDS WAS CONDUCTED. THE REPORT INDICATES THAT THE: MANUFACTURING DATE: DEC 10, 2010, PART 03.615.100 / LOT T951344, 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 ON 15-NOV-2010. 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

    INITIAL REPORTER PHONE NUMBER: (B)(6). A MANUFACTURING EVALUATION WAS COMPLETED: THE RETRACTOR FRAME EXHIBIT SOME POST PRODUCTION / ACCEPTANCE WEAR AND TEAR MARKS BUT IS IN GOOD CONDITION. THE MANUFACTURING EVALUATION SHOWS THAT THERE WERE NO ISSUES DURING THE MANUFACTURE OF THE PRODUCT THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. THE MATING FEATURES OF THE ARMS TO THE RETRACTOR BLADES WERE INSPECTED AND FOUND TO BE CONFORMING. ALL FUNCTIONS OF THE RETRACTOR FRAME WAS TESTED AND FOUND TO BE CONFORMING. A FURTHER FUNCTION TEST WAS PERFORMED WITH BOTH RETURNED BLADES 03.615.440 LOT T950951 AND 03.615.340 T956989 AND FOUND THAT THE RETRACTOR BLADE FITS WELL INTO THE ARMS, CLICKS IN AND DOESN'T FALL OUT. NO MANUFACTURING ISSUE WAS FOUND DURING INVESTIGATION. 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 ON AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT A SURGERY FOR LUMBAR SPINAL CANAL STENOSIS TOOK PLACE ON (B)(6) 2016. DURING THE SURGERY, THE SURGEON ATTACHED THE REPORTED REACTOR BLADE (CRANIAL/CAUDAL:40 MM) TO CRANIAL/CAUDAL RETRACTOR FRAME TO ASSEMBLE THE REACTOR SYSTEM. HOWEVER, THE REPORTED BLADES CAME OFF THE REACTOR FRAME DUE TO INSUFFICIENT CONNECTION BETWEEN THE BLADE AND REACTOR FRAME ON THE SURGERY. ALTHOUGH THE SURGEON TRIED TO ATTACH THE BLADE AND FRAME REPEATEDLY, THE ATTEMPT FAILED. EVENTUALLY, THE SURGEON USED REACTOR BLADE (CRANIAL/CAUDAL: 50 MM) TO COMPLETE THE SURGERY, INSTEAD. THE SURGERY WAS EXTENDED FOR 3 MINUTES. NO ADVERSE CONSEQUENCES WERE REPORTED. THIS COMPLAINT INVOLVES 2 PARTS. THIS REPORT IS 1 OF 2 FOR (B)(6).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    302557 RETRACTOR FRAME CRANIAL/CAUDAL RETRACTOR GAD SYNTHES TUTTLINGEN T951344

    Patients

    Seq Age Sex Outcome Treatment
    1