BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MATRIXMIDFACE SCREWDRIVER BLD W/SPRG HLDG SLV LONG/95MM HXC

    MDR report key: 6356336 · Received February 24, 2017

    Report

    Report Number
    2520274-2017-10588
    Event Type
    Malfunction
    Date Received
    February 24, 2017
    Date of Event
    January 24, 2017
    Report Date
    January 31, 2017
    Manufacturer
    SYNTHES HAGENDORF
    Product Code
    HXX
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE USED FOR TREATMENT, NOT DIAGNOSIS. ADDITIONAL NARRATIVE: EVENT DATE: UNKNOWN. ADDITIONAL BRAND NAME: SCRDRIVER SHAFT MATMIDF LONG W/HOLD-SLEEVE. (B)(4). LOT NUMBER UNKNOWN. DEVICE IS AN INSTRUMENT AND IS NOT IMPLANTED/EXPLANTED. DEVICE IS EXPECTED TO BE RETURNED TO SYNTHES MANUFACTURER FOR EVALUATION /INVESTIGATION, BUT HAS YET TO BE RECEIVED. (B)(6). WITHOUT A LOT NUMBER, THE DEVICE HISTORY RECORD REVIEW AND THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. 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

    A DEVICE HISTORY RECORD REVIEW (DHR) WAS PERFORMED FOR THE SUBJECT DEVICE LOT NUMBER 3172318. DHR REVIEW FOR PART# 03.503.206, LOT# 3172318. MANUFACTURING DATE: 02.JUN.2009. NO NONCONFORMANCES WERE GENERATED DURING PRODUCTION. REVIEW OF THE DEVICE HISTORY RECORD(S) 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.

    Additional Manufacturer Narrative · 1

    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

    PRODUCT DEVELOPMENT INVESTIGATION WAS COMPLETED. PART# 03.503.202: THE MANUFACTURING DOCUMENTS WERE REVIEWED AND NO COMPLAINT RELATED ISSUES WERE FOUND. THE DEVICE WAS MANUFACTURED ACCORDING TO THE SPECIFICATION IN AUGUST 2015 AND WE ARE NOT AWARE OF ANY OTHER COMPLAINT FOR THIS ARTICLE- AND LOT NUMBER. THESE FINDINGS SPEAK AGAINST ANY MANUFACTURING RELATED ISSUE. THE EVALUATION HAS SHOWN THAT THE FOREFRONT OF THE CRUCIFORM IS DISCOLORED FROM OFTEN USE. ALSO WE FOUND THAT TWO BLADES OF THE CRUCIFORM HAVE A SLIGHT DEFORMATION ON TOP, WHICH CAUSES THE COMPLAINED MALFUNCTION OF DOES NOT HOLD THE SCREW. BASED ON THE PROVIDED INFORMATION WE ARE NOT ABLE TO DETERMINE THE CAUSE OF THIS DAMAGE. THE FINDINGS THAT ONLY TWO BLADES ARE DAMAGED AND THAT THE DEFORMATIONS ARE IN CLOCKWISE DIRECTION COULD BE AN INDICATION THAT THE SCREWDRIVER WAS ONCE NOT PROPERLY ALIGNED WITH THE SCREW RECESS DURING TIGHTENING OF A SCREW. PART# 03.503.203: THE MANUFACTURING DOCUMENTS WERE REVIEWED AND NO COMPLAINT RELATED ISSUES WERE FOUND. THE DEVICE WAS MANUFACTURED ACCORDING TO THE SPECIFICATION IN MAY 2009. THE EVALUATION HAS SHOWN THAT THE DEVICE IS IN A VERY USED CONDITION, THERE IS A CLEARLY VISIBLE WEAR MARK FROM THE HOLDER ON TOP OF THE DEVICE, THE LOT NUMBER IS FADED, AND ALL FOUR BLADES ARE DISCOLORED AND ROUNDED/WORN AT THE FOREFRONT. THE WEAR AT THE FOREFRONT DOES CAUSE THE COMPLAINED MALFUNCTION OF DOES NOT HOLD. FINALLY IT CAN BE CONCLUDED THAT THIS DEVICE IS IN AN END OF LIFE CONDITION AS SPECIFIED IN THE IMPORTANT INFORMATION LEAFLET. BASED ON THE AGE AND THE USED CONDITION OF THE DEVICE A MANUFACTURING RELATED ISSUE CAN BE EXCLUDED. PART# 03.503.206: THE MANUFACTURING DOCUMENTS WERE REVIEWED AND NO COMPLAINT RELATED ISSUES WERE FOUND. THE DEVICE WAS MANUFACTURED ACCORDING TO THE SPECIFICATION IN JUNE 2009. THE EVALUATION HAS SHOWN THAT THE DEVICE IS IN A VERY USED CONDITION, THERE ARE CLEARLY VISIBLE WEAR MARKS ALL OVER THE SHAFT OF THE SCREWDRIVER, THE PART- AND THE LOT NUMBER IS FADED, ALL FOUR BLADES ARE DISCOLORED AND ROUNDED/WORN AT THE FOREFRONT. ALL FOUR PRONGS OF THE HOLDING SLEEVE ARE WORN AND TWO PRONGS ARE BENT OUTWARD. THE COMBINATION OF WEAR AT THE SCREWDRIVER BLADES AND WORN/BENT PRONGS AT THE HOLDING SLEEVE DOES CAUSE THE COMPLAINED MALFUNCTION OF DOES NOT HOLD. FINALLY IT CAN BE CONCLUDED THAT THIS DEVICE IS IN AN END OF LIFE CONDITION AS SPECIFIED IN THE IMPORTANT INFORMATION LEAFLET. BASED ON THE AGE AND THE USED CONDITION OF THE DEVICE A MANUFACTURING RELATED ISSUE CAN BE EXCLUDED. THE EXACT ROOT CAUSE CANNOT BE DEFINED, BASED ON THE APPEARANCE OF THE INAPPROPRIATE HANDLING, WEAR AND TEAR OVER THE YEARS OR A COMBINATION BETWEEN THESE FACTORS ARE THE MOST LIKELY CAUSES. 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 THE OROTHOKIT HAS ONE BROKEN SCREWDRIVER HANDLE AND THE SHAFTS OF THREE SCREWDRIVERS DO NOT HOLD THE SCREWS PROPERLY ANYMORE WHERE THEY HAVE BEEN WORN DOWN WITH HIGH USE. NO INFORMATION AVAILABLE IF THIS WAS DETECTED DURING SURGERY OR NOT. THIS COMPLAINT INVOLVES 4 PARTS. THIS REPORT IS 4 OF 4 FOR (B)(4).

    Description of Event or Problem · 1

    UPDATE ADDITIONAL INFORMATION RECEIVED 23. FEB 17: THE EVENT HAPPENED INTER-OPERATIVELY DURING SURGERY ON (B)(6) 2017. THERE WAS A DELAY IN SURGERY ¿ UNKNOWN HOW LONG. THE SURGERY WAS SUCCESSFULLY COMPLETED. NO FRAGMENTS REMOVED FROM THE PATIENT, THIS COMPLAINT IS REGARDING FAULTY INSTRUMENTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    139021 MATRIXMIDFACE SCREWDRIVER BLD W/SPRG HLDG SLV LONG/95MM HXC SCREWDRIVERS HXX SYNTHES HAGENDORF 3172318

    Patients

    Seq Age Sex Outcome Treatment
    1