BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CANNULATED 4.0MM HEXAGONAL SCREWDRIVER SHAFT

    MDR report key: 5729911 · Received June 16, 2016

    Report

    Report Number
    2530088-2016-10164
    Event Type
    Malfunction
    Date Received
    June 16, 2016
    Date of Event
    June 1, 2016
    Report Date
    June 1, 2016
    Manufacturer
    SYNTHES BRANDYWINE
    Product Code
    HXX
    PMA / PMN Number
    PEXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(6). DEVICE IS AN INSTRUMENT AND IS NOT IMPLANTED/EXPLANTED. MANUFACTURING LOCATION: (B)(4). MANUFACTURING DATE: JUNE 29, 2001. PART 314.23, LOT 4241259: NO NON-CONFORMANCE REPORTS 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. 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

    AN INVESTIGATION SUMMARY WAS PERFORMED. THE INVESTIGATION OF THE COMPLAINT ARTICLES HAS SHOWN THAT: A SERVICE ONE CANNULATED 4.0MM HEXAGONAL SCREWDRIVER SHAFT (PART#314.23 LOT#4241259) WAS RECEIVED AT CUSTOMER QUALITY (CQ) FOR EVALUATION WITH COMPLAINT CATEGORY, TIP BROKEN: INTRAOPERATIVE AND WITH COMPLAINT DESCRIPTION "...THE TIP OF THE CANNULATED SCREWDRIVER SHAFT BROKE DURING POWER INSERTION OF A 6.5MM CANNULATED SCREW." THIS COMPLAINT IS CONFIRMED, AS THE RETURNED DEVICE WAS RECEIVED AT CQ WITH THE DISTAL HEX TIP BROKEN OFF. THE BROKEN DISTAL FRAGMENT WAS NOT RETURNED FOR EVALUATION. WHETHER THIS COMPLAINT CAN BE REPLICATED AT CQ IS NOT APPLICABLE AS THE DEVICE IS ALREADY BROKEN. WE WERE UNABLE TO DETERMINE A DEFINITIVE ROOT CAUSE; HOWEVER, THE COMPLAINT CONDITION WAS MOST LIKELY CAUSED BY EXCESSIVE FORCE OR CUMULATIVE WEAR OVER THE LIFETIME OF THIS 15 YEAR OLD DEVICE ULTIMATELY LEADING IT TO FRACTURE. IT IS NOT LIKELY THAT THE DESIGN OF THE INSTRUMENT CONTRIBUTED TO THIS COMPLAINT. A VISUAL INSPECTION, DEVICE HISTORY RECORD (DHR) REVIEW, COMPLAINT HISTORY REVIEW, DRAWING REVIEW, AND RISK ASSESSMENT REVIEW WERE PERFORMED AS PART OF THIS INVESTIGATION FOR THE RETURNED PART. NO PRODUCT DESIGN ISSUES OR DISCREPANCIES WERE OBSERVED. NO NEW, UNIQUE OR DIFFERENT PATIENT HARMS WERE IDENTIFIED AS A RESULT OF THIS EVALUATION. ADDITIONALLY, THE CALCULATED OCCURRENCE RATE IS ACCEPTABLE WITH THE APPLICABLE DESIGN AND CLINICAL RISK MANAGEMENT OCCURRENCE RATE. THE RETURNED PART WAS DETERMINED TO BE SUITABLE FOR THE INTENDED USE WHEN EMPLOYED AND MAINTAINED AS RECOMMENDED. THIS INVESTIGATION SUMMARY IS APPROVED. 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AN (B)(6) FEMALE PATIENT UNDERWENT AN OPEN REDUCTION INTERNAL FIXATION (ORIF) OF THE ELBOW ON (B)(6) 2016. DURING THE PROCEDURE, THE TIP OF THE CANNULATED SCREWDRIVER SHAFT BROKE DURING POWER INSERTION OF A 6.5MM CANNULATED SCREW. THE BROKEN PIECE WAS RETRIEVED WITHOUT DIFFICULTY AND THE SCREW WAS IMPLANTED. IT WAS REPORTED THAT THE SCREWDRIVER CONTINUED TO FUNCTION IN SPITE OF THE MISSING PIECE AND THE SURGEON USED IT FOR THE REMAINDER OF THE PROCEDURE. IN TOTAL, THE PATIENT WAS IMPLANTED WITH THREE (3) PLATES WHICH INCLUDED A MINI FRAG PLATE, A MEDIAL AND A LATERAL DISTAL HUMERUS PLATE, AND APPROXIMATELY SIXTEEN (16) SCREWS WITHOUT FURTHER ISSUE. THERE WAS NO DELAY TO THE SURGERY AND THE PATIENT WAS REPORTED AS DOING WELL. CONCOMITANT DEVICE: 6.5MM CANNULATED SCREW (PART UNKNOWN, LOT UNKNOWN, QUANTITY 1). THIS IS REPORT 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    383699 CANNULATED 4.0MM HEXAGONAL SCREWDRIVER SHAFT SCREWDRIVERS HXX SYNTHES BRANDYWINE 4241259

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR