BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    REDUCTION FORCEPS WITH SERRATED JAW-RATCHET 144MM

    MDR report key: 3925355 · Received July 10, 2014

    Report

    Report Number
    9680938-2014-10034
    Event Type
    Malfunction
    Date Received
    July 10, 2014
    Date of Event
    June 12, 2014
    Report Date
    June 12, 2014
    Manufacturer
    SYNTHES TUTTLINGEN
    Product Code
    HTD
    PMA / PMN Number
    PEXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ND, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL NARRATIVE: 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 WAS USED FOR TREATMENT, NOT DIAGNOSIS. DEVICE IS AN INSTRUMENT AND IS NOT IMPLANTED/EXPLANTED. NO SERVICE HISTORY REVIEW CAN BE PERFORMED AS THIS IS A LOT CONTROLLED ITEM. THE MANUFACTURE DATE IS 20-JAN-1999. THE SOURCE OF THE MANUFACTURE DATES IS RELEASE TO WAREHOUSE DATE. 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

    ADDITIONAL NARRATIVE: SERVICE & REPAIR EVALUATION: THE CUSTOMER REPORTED THE ITEM WAS LOOSE. THE REPAIR TECHNICIAN REPORTED THE ITEM WAS BENT. THE ITEM IS NOT REPAIRABLE. THE CAUSE OF THE ISSUE IS UNKNOWN. PENDING FOR ADDITIONAL PRODUCT REVIEW/INVESTIGATION. 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: A PRODUCT INVESTIGATION WAS COMPLETED: THE RETURNED DEVICES SHOWS REGULAR USE DURING THEIR MINIMUM 16 YEAR LIFESPANS. THE HANDLES HAVE MINOR SCRATCHES AND MARKS CONSISTENT WITH REGULAR USE. THE TIP OF THE SERRATED JAWS ON BOTH DEVICES IS WORN. THE RATCHETING MECHANISM ON BOTH DEVICES IS SLIGHTLY LOOSE, BUT THE HOLDING MECHANISM FUNCTIONS AS INTENDED. A VISUAL INSPECTION, FUNCTIONAL TEST, COMPLAINT HISTORY REVIEW, DRAWING REVIEW, AND RISK ASSESSMENT REVIEW WERE PERFORMED AS PART OF THIS INVESTIGATION. NO PRODUCT DESIGN ISSUES OR DISCREPANCIES WERE OBSERVED. ALTHOUGH THE EXACT CAUSE CANNOT BE DETERMINED, THE COMPLAINT CONDITION IS MOST LIKELY THE RESULT OF TORSIONAL FORCES PLACES ON THE DEVICE DURING USE. THIS COMPLAINT IS UNCONFIRMED. THE RELEVANT DRAWINGS FOR THE DEVICE(S) WERE REVIEWED. NO DRAWING ISSUES OR DISCREPANCIES WERE NOTED. THE DESIGN IS ADEQUATE FOR ITS INTENDED USE AND DID NOT CONTRIBUTE TO THIS COMPLAINT CONDITION. PER THE TECHNIQUE GUIDE, THE FORCEPS ARE USED TO REDUCE AND SECURE AXIAL ALIGNMENT OF FRAGMENTS PRIOR TO FIXATION FOR THE 2.7 AND 3.5MM PLATING SYSTEMS. THE COMPLAINT CONDITION WAS MOST LIKELY CAUSED BY EXCESSIVE REDUCTION FORCE, RATHER THAN THE DESIGN OF THE INSTRUMENT. THERE WERE NO ISSUES FOUND WITH THE RETURNED DEVICE. THE DESIGN IS ADEQUATE FOR ITS INTENDED USE, IT DID NOT CONTRIBUTE TO THE COMPLAINT CONDITION, AND IT IS CONSISTENT WITH THE CALCULATED RISK ASSESSMENT OCCURRENCE RATE. 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

    ADDITIONAL NARRATIVE: PATIENT INFORMATION IS UNKNOWN. DEVICE WAS REPORTED AS RETURNED WHEN EVALUATION WAS REPORTED ON PREVIOUS FOLLOW UP. ON MAY 14, 2015 THE DATE DEVICE WAS RECEIVED BY MANUFACTURER WAS DETERMINED. 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 THE REDUCTION FORCEPS WITH SERRATED JAW-RATCHET 144MM WERE LOOSE, AND WHEN THE SURGEON CLAMPED THEM DOWN, THE FORCEPS WOULD NOT STAY CLAMPED. THE SURGEON WAS ABLE TO USE A SPARE DEVICE TO COMPLETE THE PROCEDURE WITH NO NEGATIVE IMPACT OR ANY TIME DELAY. THERE ARE 2 PARTS IN THIS COMPLAINT. THIS REPORT IS 1 OF 2 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    403354 REDUCTION FORCEPS WITH SERRATED JAW-RATCHET 144MM FORCEPS HTD SYNTHES TUTTLINGEN 3912584

    Patients

    Seq Age Sex Outcome Treatment
    1