BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HAMMER 500 GRAMS

    MDR report key: 4247734 · Received November 13, 2014

    Report

    Report Number
    9680938-2014-10085
    Event Type
    Malfunction
    Date Received
    November 13, 2014
    Report Date
    October 20, 2014
    Manufacturer
    SYNTHES TUTTLINGEN
    Product Code
    FZY
    PMA / PMN Number
    PEXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL NARRATIVE: PRODUCT INVESTIGATION: ONE OF EACH OF THE FOLLOWING WAS RECEIVED: HAMMER 500 GRAMS (PART # 399.420 / LOT # 5133451 / MFG LOCATION: (B)(4)/ MFG. DATE: 12/2005). DEPTH GAUGE (PART # 319.090 / LOT # 4561369/ MFG LOCATION: (B)(4)/ MFG. DATE: 03/2003). DEPTH GAUGE (PART # 319.006 / LOT # 5239721 / MFG LOCATION: (B)(4)/ MFG. DATE: 05/2006). DEPTH GAUGE (PART # 319.006 / LOT # 6230553 / MFG LOCATION: (B)(4)/ MFG. DATE: 09/2009). THE RETURNED DEVICES SHOW SIGNIFICANT USE DURING THEIR MINIMUM 5 YEAR LIFESPANS. THE HAMMER HEAD HAS NUMEROUS DENTS AND GOUGES FROM REPEATED USE, AND THE SHAFT IS BROKEN AND NO LONGER ATTACHED TO THE HEAD. THE DAMAGE TO THE HAMMER APPEARS TO BE THE RESULT OF REPEATED USE OVER THE LIFE (10 YEARS) OF THE INSTRUMENT. THE DISTAL TIP OF ALL THE DEPTH GAUGES IS SIGNIFICANTLY DEFORMED AND BENT, AND THE BALL PLUNGER OF BOTH PART #'S 319.006 IS STUCK AND DOES NOT WORK. DAMAGE ON ALL INSTRUMENTS APPEARS TO BE THE RESULT OF WEAR ACCUMULATED OVER THE LIFE OF THE INSTRUMENTS. DRAWINGS FOR THE DEVICE(S) WERE REVIEWED. THREE DESIGN REVISIONS WERE PERFORMED FOLLOWING THE MANUFACTURING OF THIS DEVICE. THESE REVISIONS WERE TO ADD ADDITIONAL LASER MARKING AS WELL AS TO CHANGE THE MATERIAL OF THE SHAFT AND HAMMER HEAD. CHANGES DID NOT IMPACT THE HANDLE. THE DESIGN IS ADEQUATE FOR ITS INTENDED USE AND DID NOT CONTRIBUTE TO THIS COMPLAINT CONDITION. THE COMPLAINT CONDITION WAS CAUSED BY WEAR OVER THE LIFE OF THE INSTRUMENT, RATHER THAN THE DESIGN OF THE INSTRUMENT. DRAWINGS FOR THE DEVICE(S) WERE REVIEWED. NO DRAWING ISSUES OR DISCREPANCIES WERE NOTED. THE DESIGNS ARE ADEQUATE FOR THEIR INTENDED USE AND DID NOT CONTRIBUTE TO THIS COMPLAINT CONDITION THIS COMPLAINT CONDITION IS POSSIBLY A RESULT OF ACCUMULATED WEAR OVER THE LIFE OF THE INSTRUMENT, AND NOT THE DEVICE'S DESIGN. BECAUSE OF THIS, THE COMPLAINT IS DETERMINED NOT TO BE A DESIGN DEFICIENCY. THE RETURNED PART(S) ARE DETERMINED TO BE SUITABLE FOR THEIR INTENDED USE WHEN USED AND MAINTAINED AS RECOMMENDED. THIS COMPLAINT IS CONFIRMED, BUT THE DESIGN OF THE DEVICE DID NOT CONTRIBUTE TO THIS COMPLAINT. 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

    ADDITIONAL NARRATIVE: SERVICE HISTORY REVIEW: LOT A7OA48/5133451: NO SERVICE HISTORY REVIEW CAN BE PERFORMED AS THIS IS A LOT CONTROLLED ITEM. THE SERVICE HISTORY EVALUATION IS UNCONFIRMED. A SERVICE AND REPAIR EVALUATION WAS COMPLETED: THE CUSTOMER REPORTED THE ITEM WAS BROKEN. THE REPAIR TECHNICIAN REPORTED THE HEAD OF THE ITEM BROKE OFF FROM THE SHAFT. THE ITEM IS NOT REPAIRABLE. THE CAUSE OF THE ISSUE IS UNKNOWN. THIS ITEM WAS FORWARDED TO THE COMPLAINT HANDLING UNIT. THE EVALUATION WAS CONFIRMED. 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

    EVENT DATE: UNKNOWN. DEVICE IS AN INSTRUMENT AND IS NOT IMPLANTED/EXPLANTED. 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A 500 GRAM HAMMER WAS FOUND BROKEN. THE HEAD HAD SEPARATED FROM THE HANDLE. THERE WAS NO PATIENT OR PROCEDURE INVOLVEMENT. THIS IS REPORT 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    734489 HAMMER 500 GRAMS HAMMER,SURGICAL FZY SYNTHES TUTTLINGEN 5133451

    Patients

    Seq Age Sex Outcome Treatment
    1