BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BONE HOLDING FORCEPS-SOFT RATCHET F/PLATES TO 9MM WIDE

    MDR report key: 5372897 · Received January 17, 2016

    Report

    Report Number
    1719045-2016-10072
    Event Type
    Malfunction
    Date Received
    January 17, 2016
    Date of Event
    December 29, 2015
    Report Date
    December 30, 2015
    Manufacturer
    SYNTHES SALZBURG
    Product Code
    HTD
    PMA / PMN Number
    PEXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT INVESTIGATION SUMMARY: THE COMPLAINT CONDITION FOR THE BONE HOLDING FORCEPS (PART 399.091 / LOT 5010242) WAS LIKELY CAUSED BY OVER NINE YEARS OF CONSISTENT USE AND POSSIBLE ROUGH HANDLING DURING SURGERY OR STERILE PROCESSING; HOWEVER, THIS COMPLAINT IS NOT LIKELY A RESULT OF ANY DESIGN RELATED DEFICIENCY. THE BONE HOLDING FORCEPS ARE AN INSTRUMENT ROUTINELY USED IN THE SMALL FRAGMENT LOCKING COMPRESSION PLATE (LCP) SYSTEM. THE DEVICE WAS RETURNED AND REPORTED THAT THE TIP HAD BROKEN OFF DURING SURGERY. THIS CONDITION IS CONFIRMED AS APPROXIMATELY 25 MILLIMETERS OF THE DISTAL PORTION OF THE LOWER JAW HAS BEEN BROKEN OFF. IT IS LIKELY THAT OVER NINE YEARS OF CONSISTENT USE AND POSSIBLE ROUGH HANDLING DURING SURGERY OR STERILE PROCESSING HAS LED TO THIS COMPLAINT CONDITION. THE DEVICE WAS MANUFACTURED IN MARCH, 2006 AND IS OVER NINE YEARS OLD. THE BALANCE OF THE RETURNED DEVICE IS IN FAIRLY WORN CONDITION WITH SEVERAL MARKINGS AND SIGNS OF WEAR ALONG ITS LENGTH. THE RELEVANT DRAWING NUMBER WAS REVIEWED AND DETERMINED TO BE SUITABLE FOR THE INTENDED DESIGN, APPLICATION, AND DIMENSIONAL CONFORMITY WHEN USED AS RECOMMENDED. DEVICE HISTORY RECORD REVIEW: MANUFACTURING LOCATION: (B)(4) - MANUFACTURING DATE: MARCH 22, 2006. NO NON-CONFORMANCE REPORTS WERE GENERATED DURING PRODUCTION. REVIEW OF THE DEVICE HISTORY RECORD(S) SHOWED THAT THERE WERE NO ISSUES DURING THE MANUFACTURE OF THE PRODUCT THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. 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.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. PATIENT INFORMATION WAS NOT PROVIDED BY REPORTER. DEVICE IS AN INSTRUMENT AND IS NOT IMPLANTED/EXPLANTED. A SERVICE HISTORY RECORD REVIEW WAS ATTEMPTED FOR THE SUBJECT DEVICE LOT; HOWEVER, THE REVIEW COULD NOT BE COMPLETED BECAUSE THE DEVICE IS A LOT CONTROLLED ITEM. THE REVIEW SHOWED THAT THERE WERE NO ISSUES DURING THE MANUFACTURE OF THE PRODUCT THAT THE MANUFACTURE DATE OF THIS ITEM IS 7-APR-2006. THE SOURCE OF THE MANUFACTURE DATE IS THE RELEASE TO WAREHOUSE DATE. THE SERVICE HISTORY EVALUATION IS UNCONFIRMED. THE SUBJECT DEVICE HAS BEEN RECEIVED AND IS CURRENTLY IN THE EVALUATION PROCESS. 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 ON AN UNKNOWN DATE THE PATIENT UNDERWENT AN OPEN REDUCTION INTERNAL FIXATION (ORIF) SURGERY OF THE ULNA/RADIUS AND DURING THE SURGERY THE TIP OF THE FORCEPS BROKE OFF. THE TIP WAS RETRIEVED AND IS AVAILABLE FOR RETURN. THERE WAS NO DELAY TO SURGERY. NO PATIENT HARM REPORTED. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THIS REPORT IS 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    31414 BONE HOLDING FORCEPS-SOFT RATCHET F/PLATES TO 9MM WIDE FORCEPS HTD SYNTHES SALZBURG 5010242

    Patients

    Seq Age Sex Outcome Treatment
    1