BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DETACHABLE SLIDE HAMMER 580 GRAMS

    MDR report key: 6515964 · Received April 24, 2017

    Report

    Report Number
    1719045-2017-10341
    Event Type
    Malfunction
    Date Received
    April 24, 2017
    Report Date
    April 3, 2017
    Manufacturer
    SYNTHES MONUMENT
    Product Code
    FZY
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    IT WAS REPORTED THAT THE HANDLE OF THE SLOTTED HAMMER IS BROKEN IN HALF. THE DEVICE BROKE EXACTLY WHERE THE METAL SHAFT ENDS INSIDE OF THE HANDLE. IT IS UNKNOWN HOW AND WHEN THIS ISSUE OCCURRED. IT IS UNKNOWN IF THERE IS A CASE OR PATIENT INVOLVEMENT. HOSPITAL CONFIRMED THAT THE ISSUE DID NOT CAUSE ANY PATIENT OR EMPLOYEE HARM. CUSTOMER QUALITY (CQ) ENGINEERING INVESTIGATION: THIS COMPLAINT IS CONFIRMED. THE HANDLE COMPONENT OF THE RETURNED HAMMER IS IN TWO PIECES. THE HANDLE BROKE IN HALF AT THE PROXIMAL END OF THE INTERNAL METAL SHAFT. WHETHER THIS COMPLAINT CAN BE REPLICATED AT CUSTOMER QUALITY (CQ) IS NOT APPLICABLE FOR THIS COMPLAINT CONDITION AS THE RETURNED DEVICE IS ALREADY BROKEN. NO NEW MALFUNCTIONS WERE IDENTIFIED AS A RESULT OF THE INVESTIGATION. THE RETURNED DETACHABLE SLIDE HAMMER 580 GRAMS IS A REUSABLE INSTRUMENT AVAILABLE FOR USE IN THE TITANIUM CANNULATED NAIL EXTRACTION SET AND USED TO AID IN REMOVAL OF BROKEN OR INTACT TITANIUM CANNULATED NAILS PER TECHNIQUE GUIDE. A VISUAL INSPECTION UNDER 5X MAGNIFICATION, DEVICE HISTORY RECORD (DHR) REVIEW AND DRAWING REVIEW WERE PERFORMED ON THE RETURNED DEVICE AS PART OF THIS INVESTIGATION. VISUAL INSPECTION THE HANDLE COMPONENT OF THE RETURNED HAMMER IS IN TWO PIECES. THE HANDLE BROKE IN HALF AT THE PROXIMAL END OF THE INTERNAL METAL SHAFT. NO FRAGMENTS APPEAR TO HAVE BEEN GENERATED DURING THE BREAK AS NO GAPS OR VOIDS EXIST WHEN THE BROKEN HANDLE PARTS ARE ALIGNED BACK TOGETHER. DHR REVIEW FOR PART # 357.026 LOT # 1002889. RELEASE TO WAREHOUSE DATE: 24 JUN 1998 SUPPLIER: (B)(4) MRR # 28588 WAS GENERATED ON 6/25/1998 FOR A TOTAL OF SEVEN (7) DEVICES REJECTED FOR THE ETCH LOCATION, DID NOT MATCH THE PRINT. THIS NON-CONFORMANCE IS NOT RELEVANT TO THE COMPLAINT ISSUE. DRAWING REVIEW: DRAWING SM AND SE WERE REVIEWED DURING THIS INVESTIGATION. NO PRODUCT DESIGN ISSUES OR DISCREPANCIES WERE OBSERVED. MOST LIKELY DUE TO CUMULATIVE WEAR FOR THIS 18+YEAR OLD RESUABLE HAMMER. 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. THERE WAS NO REPORTED PATIENT INVOLVEMENT ASSOCIATED WITH THE COMPLAINED EVENT. OTHER NUMBER ¿ UDI: (B)(4) GTIN UNAVAILABLE, PRODUCT MADE PRIOR TO (B)(4). DEVICE IS AN INSTRUMENT AND IS NOT IMPLANTED/EXPLANTED. THE SUBJECT DEVICE IS EXPECTED TO BE RETURNED TO THE SYNTHES MANUFACTURER FOR EVALUATION BUT HAS NOT YET BEEN RECEIVED. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. A DEVICE HISTORY RECORD REVIEW WAS PERFORMED FOR THE SUBJECT DEVICE LOT. MANUFACTURER: SYNTHES (B)(4). DATE OF MANUFACTURE: JUN 24, 1998. THE REVIEW SHOWED A TOTAL OF SEVEN (7) DEVICES WERE REJECTED FOR ETCH LOCATION THAT DID NOT MATCH THE PRINT SPECIFICATION. THIS NONCONFORMANCE IS NOT RELEVANT TO THE COMPLAINT ISSUE. THAT THERE WERE NO ISSUES DURING THE MANUFACTURE OF THE PRODUCT THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. 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. THE SUBJECT DEVICE HAS BEEN RECEIVED BY THE MANUFACTURER AND IS UNDERGOING INVESTIGATION. THE RESULTS OF THE INVESTIGATION ARE PENDING COMPLETION AND WILL BE SUBMITTED IN A SUPPLEMENTAL REPORT. 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 HANDLE OF THE SLIDE HAMMER IS BROKEN IN HALF. THE DEVICE BROKE EXACTLY WHERE THE METAL SHAFT ENDS INSIDE OF THE HANDLE. IT IS UNKNOWN HOW AND WHEN THIS ISSUE OCCURRED. IT IS UNKNOWN IF THERE IS A CASE OR PATIENT INVOLVEMENT. THE HOSPITAL CONFIRMED THAT THE ISSUE WAS FOUND DURING INSPECTION DID NOT CAUSE ANY PATIENT OR EMPLOYEE HARM. THIS REPORT IS 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    297397 DETACHABLE SLIDE HAMMER 580 GRAMS HAMMER, SURGICAL FZY SYNTHES MONUMENT 1002889

    Patients

    Seq Age Sex Outcome Treatment
    1