BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    REDUCTION FORCEPS WITH SERRATED JAW-RATCHET 144MM

    MDR report key: 4869664 · Received June 25, 2015

    Report

    Report Number
    9680938-2015-10054
    Event Type
    Malfunction
    Date Received
    June 25, 2015
    Date of Event
    June 12, 2015
    Report Date
    June 12, 2015
    Manufacturer
    SYNTHES TUTTLINGEN
    Product Code
    HTD
    PMA / PMN Number
    PEXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    SERVICE HISTORY REVIEW: LOT A7NA44/4915203 - NO SERVICE HISTORY REVIEW CAN BE PERFORMED AS THIS IS A LOT CONTROLLED ITEM. THE MANUFACTURE DATE OF THIS ITEM IS JANUARY 3, 2005. THE SOURCE OF THE MANUFACTURE DATE IS THE RELEASE TO WAREHOUSE DATE.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

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. ADDITIONAL NARRATIVE: DEVICE IS AN INSTRUMENT AND IS NOT IMPLANTED/EXPLANTED. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. A REVIEW OF THE DEVICE HISTORY RECORDS HAS BEEN REQUESTED. 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. 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. ADDITIONAL INFORMATION: A PRODUCT DEVELOPMENT INVESTIGATION WAS PERFORMED FOR THE SUBJECT DEVICE (PART NUMBER, 399.99, REDUCTION FORCEPS WITH SERRATED JAW, RATCHET, LOT NUMBER 4915203/ SUPPLIER LOT NUMBER A7NA44). THE SUBJECT DEVICE WAS RECEIVED WITH THE COMPLAINT OF ¿BROKEN: INTRAOPERATIVELY.¿ THE SUBJECT DEVICE IS PART OF THE SMALL FRAGMENT INSTRUMENTS AND IMPLANTS SET AND IS UTILIZED IN VARIOUS PROCEDURES FOR FRACTURE REDUCTION. THIS INFORMATION IS PROVIDED PER THE SMALL FRAGMENT LOCKING COMPRESSION PLATE (LCP) SYSTEM TECHNIQUE GUIDE. THE RETURNED DEVICE WAS RECEIVED WITH ONE OF THE DISTAL POINTS BROKEN OFF APPROXIMATELY HALFWAY INTO THE SERRATED PORTION. THE BREAK IS LOCATED BETWEEN THE 4TH AND 5TH TEETH (FROM DISTAL) AND THE BROKEN PORTION WAS NOT RETURNED. THERE ARE MARKINGS ON THE REMAINING DISTAL POINT. THE BALANCE OF THE DEVICE IS IN WORKING CONDITION WITH ONLY SURFACE WEAR. THUS, THE COMPLAINT CONDITION IS CONFIRMED BUT CANNOT BE REPLICATED AS THE DEVICE IS ALREADY BROKEN. A REVIEW OF THE CURRENT DESIGN DRAWING AND THE DRAWING REVISION AT THE TIME OF MANUFACTURE WAS PERFORMED. DURING THE INVESTIGATION NO PRODUCT DESIGN ISSUES OR DISCREPANCIES WERE OBSERVED THAT MAY HAVE CONTRIBUTED TO THE COMPLAINT CONDITION. THE RETURNED PART WAS DETERMINED TO BE SUITABLE FOR THE INTENDED USE WHEN EMPLOYED AND MAINTAINED AS RECOMMENDED. THE COMPLAINT CONDITION IS CONFIRMED AS THE RETURNED DEVICE WAS RECEIVED WITH ONE OF THE DISTAL POINTS BROKEN OFF APPROXIMATELY HALFWAY INTO THE SERRATED PORTION. ALTHOUGH THE ROOT CAUSE CANNOT BE DEFINITIVELY DETERMINED WITHOUT ADDITIONAL INFORMATION REGARDING THE USER TECHNIQUE AND THE CONDITIONS AT THE TIME OF THE DAMAGE, THE RETURNED CONDITION IS CONSISTENT WITH EXCESSIVE FORCE AND/OR EXTENSIVE WEAR OVER THE DEVICES 10.5 YEAR LIFETIME. THE RETURNED PART WAS DETERMINED TO BE SUITABLE FOR THE INTENDED USE WHEN EMPLOYED AND MAINTAINED AS RECOMMENDED. MEDWATCH FOLLOW UP #2 STATED A SECOND SERVICE HISTORY RECORD REVIEW WAS PERFORMED BUT IT WAS A SERVICE AND REPAIR EVALUATION WHICH WAS COMPLETED. THE RESULTS WERE REPORTED IN THE MEDWATCH FOLLOW UP REPORTS #2 AND #3. 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 SECOND SERVICE & REPAIR HISTORY MAINTENANCE REVIEW WAS PERFORMED. THE CUSTOMER REPORTED THE ITEM WAS BROKEN. THE REPAIR TECHNICIAN REPORTED THE TIP WAS BROKEN. TIP BROKEN IS THE REASON FOR REPAIR. THE ITEM IS NOT REPAIRABLE. THE CAUSE OF THE ISSUE IS UNKNOWN. THIS ITEM WAS FORWARDED TO THE COMPLAINT HANDLING UNIT ON 23-JUL-2015. 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE REDUCTION FORCEPS WITH SERRATED JAW-RATCHET 144MM BROKE OFF INTO TWO PIECES. ONE PIECE FELL INTO THE PATIENT, BUT WAS RETRIEVED WITH NO PATIENT HARM. THERE WAS ANOTHER SET AVAILABLE IN THE TRAY AND THERE WAS A SURGICAL DELAY OF 5 MINUTES REPORTED. THIS REPORT IS 1 OF 1 FOR (B)(4).

    Description of Event or Problem · 1

    UPDATE: PART RETURNED TO MONUMENT ON (B)(4) 2015 PER E-MAIL FROM MONUMENT, AND ALSO PART RETURNED TO CHU ON (B)(4) 2015 PER E-MAIL FROM MONUMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    413563 REDUCTION FORCEPS WITH SERRATED JAW-RATCHET 144MM FORCEPS HTD SYNTHES TUTTLINGEN 4915203

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR