BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CRUCIFORM SCREWDRIVER

    MDR report key: 6557081 · Received May 10, 2017

    Report

    Report Number
    3003875359-2017-10226
    Event Type
    Malfunction
    Date Received
    May 10, 2017
    Date of Event
    April 11, 2017
    Report Date
    April 13, 2017
    Manufacturer
    SYNTHES BRANDYWINE
    Product Code
    HXX
    UDI-DI
    07611819757424
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    A DEVICE HISTORY RECORD (DHR) REVIEW WAS PERFORMED FOR PART # 313.960, LOT # 5114976: PART #313.96(0), LOT #5114976 IS A SUBCOMPONENT OF PART #313.94 WHICH IS THE TOP LEVEL SALEABLE DEVICE. THE DHR WAS ABLE TO BE NARROWED DOWN TO THE TWO LOT #'S BELOW (5123074 & 5123075). HOWEVER, IT CANNOT BE DEFINITIVELY DETERMINED WHICH LOT # IS CORRECT BUT BOTH SHARE THE SAME RELEASE TO WAREHOUSE DATE AND NO NON CONFORMANCE REPORTS (NCRS). THE 2.4 MM SCREWDRIVER WITH HOLDING SLEEVE: DHR REVIEW FOR PART#313.94, LOT#5123074: RELEASE TO WAREHOUSE DATE: 23-NOV-2005, EXPIRATION DATE: NA, SUPPLIER: (B)(4). CRUCIFORM SCREWDRIVER (SUBCOMPONENT OF 313.94): DHR REVIEW FOR PART #319.96, LOT #5114976: RELEASE TO ASSEMBLY DATE: 14-NOV-2005, EXPIRATION DATE: NA, SUPPLIER: (B)(4). BLADE (SUBCOMPONENT OF 313.96): DHR REVIEW FOR PART #319.96.01, LOT #5101967: RELEASE TO ASSEMBLY DATE: 9-NOV-2005, EXPIRATION DATE: NA, SUPPLIER: (B)(4). HOLDING SLEEVE (SUBCOMPONENT OF 313.94): DHR REVIEW FOR PART #319.97, LOT #5122024: RELEASE TO ASSEMBLY DATE: 23-NOV-2005, EXPIRATION DATE: NA, SUPPLIER: (B)(4). THE 2.4 MM SCREWDRIVER WITH HOLDING SLEEVE: DHR REVIEW FOR PART#313.94, LOT#5123075: RELEASE TO WAREHOUSE DATE: 23-NOV-2005, EXPIRATION DATE: NA, SUPPLIER: (B)(4). CRUCIFORM SCREWDRIVER (SUBCOMPONENT OF 313.94): DHR REVIEW FOR PART #319.96, LOT #5114976: RELEASE TO ASSEMBLY DATE: 14-NOV-2005, EXPIRATION DATE: NA, SUPPLIER: (B)(4). BLADE (SUBCOMPONENT OF 319.96): DHR REVIEW FOR PART #319.96.01, LOT #5101967: RELEASE TO ASSEMBLY DATE: 9-NOV-2005, EXPIRATION DATE: NA, SUPPLIER: (B)(4). HOLDING SLEEVE (SUBCOMPONENT OF 313.94): DHR REVIEW FOR PART #319.97, LOT #5122025: RELEASE TO ASSEMBLY DATE: 23-NOV-2005, EXPIRATION DATE: NA, SUPPLIER: (B)(4). NO NCRS WERE GENERATED DURING PRODUCTION. REVIEW OF THE DEVICE HISTORY RECORD(S) SHOWED THAT THERE WERE NO ISSUES DURING THE MANUFACTURE OF THIS PRODUCT THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. A PRODUCT INVESTIGATION WAS PERFORMED. THE SCRDRIVER-CRUCIF NOT SELF-HOLDING F/CORT (PART # 313.960, LOT # 5114976) WAS RECEIVED FOR INVESTIGATION. UPON VISUAL INSPECTION OF THE COMPLAINT DEVICE IT CAN BE SEEN THAT THE TIP OF THE INSTRUMENT IS BROKEN AS REPORTED, THIS THUS CONFIRMING THE COMPLAINT DESCRIPTION. FURTHERMORE THE ARTICLE IS USED BUT IN GOOD CONDITION. WE CLASSIFY THIS AS NORMAL WEAR AND TEAR AND SUCH INSTRUMENTS MUST BE REPLACED FROM TIME TO TIME. BASED TO THE MENTIONED FINDINGS, NO FURTHER INVESTIGATION WILL BE DONE (DIMENSION, MATERIAL, HARDNESS), SINCE THE MENTIONED ARTICLE HAS BEEN IN USE FOR MORE THAN ELEVEN (11) YEARS. 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

    (B)(6). A REVIEW OF THE DEVICE HISTORY RECORDS HAS BEEN REQUESTED AND IS CURRENTLY PENDING COMPLETION. THE DEVICE HAS BEEN RECEIVED AND THE PRODUCT EVALUATION IS IN PROGRESS. NO CONCLUSION CAN BE DRAWN. 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 (B)(4) REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT DURING A STRAIGHT FORWARD STERNAL CLOSURE CASE PERFORMED ON (B)(6) 2017, SURGEON WAS USING THE SCREWDRIVER WITH HOLDING SLEEVE FROM THE TITANIUM STERNAL FIXATION SYSTEM WHEN PART OF THE SCREWDRIVER BLADE BROKE OFF INTO THE HEAD OF THE LOCKING SCREW WHICH WAS IN THE PATIENT. SURGEON WAS NOT APPLYING FORCE, JUST SCREWING THE LOCKING SCREW IN AS HE USUALLY WOULD. GIVEN THERE WAS A BROKEN FRAGMENT LODGED INTO THE SCREW HEAD THEY WERE UNABLE TO REMOVE THE SCREW. THEN A HIGH-SPEED DRILL BIT WAS USED TO DRILL OUT THE BROKEN FRAGMENT OF SCREWDRIVER BLADE FROM THE HEAD OF THE SCREW. THE FRAGMENT CAME OUT OF THE SCREW HEAD, THE SCREW REMAINED WITHIN THE PLATE IN THE PATIENT AS SURGEON WAS UNABLE TO REMOVE THE SCREW. SURGEON IS HAPPY FOR THE SCREW TO REMAIN IN THE PATIENT GIVEN THAT THE SCREWDRIVER FRAGMENT HAD BEEN REMOVED. THERE WAS SURGICAL DELAY OF TWENTY (20) MINUTES DUE TO THE REPORTED ISSUE. NO ADVERSE EVENT TO PATIENT. AS PER SURGEON THE POST-OPERATIVE OUTCOME OF THE PATIENT IS FINE AND HIS STERNUM IS VERY STABLE. CONCOMITANT DEVICES REPORTED: 3.0MM TI LOCKING SCREW 14MM F/STERNAL LOCKING PLATES(PART # 413.584, LOT # UNKNOWN, QUANTITY 1), HOLDING SLEEVE (PART # 313.970 , LOT # UNKNOWN, QUANTITY 1), TI STERNAL LOCKING X PLATE 10 HOLES(PART # 460.037, LOT # UNKNOWN, QUANTITY 1). THIS REPORT IS FOR ONE (1) CRUCIFORM SCREWDRIVER. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    340240 CRUCIFORM SCREWDRIVER SCREWDRIVERS HXX SYNTHES BRANDYWINE 5114976 07611819757424

    Patients

    Seq Age Sex Outcome Treatment
    1 HOLDING SLEEVE (PART # 313.970 , LOT # UNK, QTY 1)| STERNAL PLATE (PART # 460.037, LOT # UNK, QTY 1)