BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COMPRESSION FORCEPS

    MDR report key: 6090152 · Received November 9, 2016

    Report

    Report Number
    9680938-2016-10170
    Event Type
    Malfunction
    Date Received
    November 9, 2016
    Date of Event
    October 14, 2016
    Report Date
    October 14, 2016
    Manufacturer
    SYNTHES TUTTLINGEN
    Product Code
    HWN
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS NO ADDITIONAL INFORMATION HAS BEEN RECEIVED FOR THIS FIELD. A PRODUCT DEVELOPMENT INVESTIGATION WAS PERFORMED FOR THE SUBJECT DEVICE. IT WAS REPORTED THAT COMPRESSION FORCEPS BROKE DURING AN OPEN REDUCTION INTERNAL FIXATION (ORIF) OF THE FOOT ON (B)(6) 2016. THE SURGEON WAS FINISHED USING THE FORCEPS WHEN THEY BROKE. THERE WAS A ONE OR TWO MINUTE SURGICAL DELAY TO LOCATE AND RECOVER THE PIECES IN THE OPERATING ROOM. THERE WAS NO ADDITIONAL INTERVENTION AND NO HARM TO THE PATIENT. THE SURGERY WAS SUCCESSFULLY COMPLETED WITH A SATISFACTORY PATIENT OUTCOME. THIS COMPLAINT IS CONFIRMED, ONE OF THE TWO DISTAL ARMS HAS SHEARED OFF JUST DISTAL TO THE HINGE. THE BREAK IS AT THE TRANSITION FROM THE WIDE HINGE CROSS SECTION TO THE NARROW ARM CROSS SECTION. THE SHEARED OFF ARM WAS ALSO RETURNED TO CUSTOMER QUALITY. WHETHER THIS COMPLAINT CAN BE REPLICATED IS NOT APPLICABLE AS THE DEVICE IS ALREADY BROKE. A DEFINITIVE ROOT CAUSE WAS NOT DETERMINED. HOWEVER, THE COMPLAINT CONDITION WAS MOST LIKELY CAUSED BY APPLICATION OF EXCESSIVE FORCE OR CUMULATIVE WEAR DURING 6 YEARS OF FIELD USE. IT IS NOT LIKELY THAT THE DESIGN OF THE DEVICE CONTRIBUTED TO THIS COMPLAINT. A VISUAL INSPECTION UNDER 5X MAGNIFICATION, DEVICE HISTORY RECORD (DHR) REVIEW, COMPLAINT HISTORY REVIEW, DRAWING REVIEW, AND RISK ASSESSMENT REVIEW WERE PERFORMED AS PART OF THIS INVESTIGATION. 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. 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. DEVICE IS AN INSTRUMENT AND IS NOT IMPLANTED/EXPLANTED. SUBJECT DEVICE HAS BEEN RECEIVED AND IS CURRENTLY IN THE EVALUATION PROCESS. INVESTIGATION IS ONGOING; NO CONCLUSION COULD BE DRAWN AS PRODUCT IS ENTERING THE COMPLAINT SYSTEM. DEVICE HISTORY RECORDS REVIEW WAS CONDUCTED. THE REPORT INDICATES THAT: DHR REVIEW FOR: PART NUMBER 03.211.400 LOT NUMBER T950761, MANUFACTURING DATE: 16-NOV-2010 REVIEW OF THE DEVICE HISTORY RECORD OF (B)(4) SHOWED THAT THERE WERE NO ISSUES AT THE TIME OF MANUFACTURING OF THIS DEVICE THAT WOULD CONTRIBUTE TO THE ISSUE OUTLINED IN THIS COMPLAINT. A REVIEW OF INSPECTION RECORDS AND CERTIFICATIONS, CONFIRM THAT THE COMPONENTS AND FINAL PRODUCT MET INSPECTION RECORDS. ALL (B)(4) PARTS OF THE LOT WERE CHECKED 100% FOR CRITICAL FEATURES AND FOR FUNCTION AT THE FINAL INSPECTION ON 15-NOV-2010. NO NCRS WERE GENERATED DURING PRODUCTION. 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 COMPRESSION FORCEPS BROKE DURING AN OPEN REDUCTION INTERNAL FIXATION (ORIF) OF THE FOOT ON (B)(6) 2016. THE SURGEON WAS FINISHED USING THE FORCEPS WHEN THEY BROKE. THERE WAS A ONE OR TWO MINUTE SURGICAL DELAY TO LOCATE AND RECOVER THE PIECES IN THE OPERATING ROOM. THERE WAS NO ADDITIONAL INTERVENTION AND NO HARM TO THE PATIENT. THE SURGERY WAS SUCCESSFULLY COMPLETED WITH A SATISFACTORY PATIENT OUTCOME. THIS REPORT IS 1 OF 1 FOR (B)(4).

    Description of Event or Problem · 1

    DEVICE REPORT FROM SYNTHES ON AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT COMPRESSION FORCEPS BROKE DURING AN OPEN REDUCTION INTERNAL FIXATION (ORIF) OF THE FOOT ON (B)(6) 2016. THE SURGEON WAS FINISHED USING THE FORCEPS WHEN THEY BROKE. THERE WAS A ONE OR TWO MINUTE SURGICAL DELAY TO LOCATE AND RECOVER THE PIECES IN THE OPERATING ROOM. THERE WAS NO ADDITIONAL INTERVENTION AND NO HARM TO THE PATIENT. THE SURGERY WAS SUCCESSFULLY COMPLETED WITH A SATISFACTORY PATIENT OUTCOME. THIS COMPLAINT INVOLVES ONE DEVICE. THIS REPORT IS 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    739834 COMPRESSION FORCEPS N/A HWN SYNTHES TUTTLINGEN T950761

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR