BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    REDUCTION FORCEPS WITH SERRATED JAW-RATCHET 144MM

    MDR report key: 5257964 · Received December 1, 2015

    Report

    Report Number
    9680938-2015-10118
    Event Type
    Malfunction
    Date Received
    December 1, 2015
    Date of Event
    November 11, 2015
    Report Date
    November 12, 2015
    Manufacturer
    SYNTHES TUTTLINGEN
    Product Code
    HTD
    PMA / PMN Number
    PEXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A SERVICE AND REPAIR EVALUATION WAS COMPLETED: THE CUSTOMER REPORTED THE TIP BROKE OFF. THE REPAIR TECHNICIAN REPORTED THE TIP BROKE AT THE JAW AREA. TIP BROKEN IS THE REASON FOR REPAIR. THE ITEM IS NOT REPAIRABLE. THE CAUSE OF THE ISSUE IS UNKNOWN. THE ITEM WILL BE FORWARDED TO THE COMPLAINT HANDLING UNIT. THE EVALUATION WAS CONFIRMED. A PRODUCT INVESTIGATION WAS COMPLETED: THE COMPLAINT CONDITION FOR THE 399.99 LOT NUMBER T952323 REDUCTION FORCEPS WAS LIKELY CAUSED BY OVER FIVE YEARS OF USE AND POSSIBLY THE APPLICATION OF EXCESSIVE FORCE DURING SURGERY; HOWEVER, THIS COMPLAINT IS NOT LIKELY A RESULT OF ANY DESIGN RELATED DEFICIENCY. PER THE TECHNIQUE GUIDE, THE 399.99 REDUCTION FORCEPS IS AN INSTRUMENT ROUTINELY USED IN THE SMALL FRAGMENT LOCKING COMPRESSION PLATE (LCP) SYSTEM. THE DEVICE WAS RETURNED AND REPORTED TO HAVE BROKEN AT THE TIP INTRA-OPERATIVELY. THIS CONDITION IS CONFIRMED; THE TIP OF ONE OF THE SERRATED JAWS IS BROKEN APPROXIMATELY FIFTEEN MILLIMETERS FROM THE DISTAL TIP ALONG A HOMOGENOUS FRACTURE SURFACE. IT IS LIKELY THAT OVER FIVE YEARS OF USE AND POSSIBLY THE APPLICATION OF EXCESSIVE FORCE DURING SURGERY HAVE LED TO THIS COMPLAINT CONDITION. THE DEVICE WAS MANUFACTURED IN OCTOBER 2010 AND IS OVER FIVE YEARS OLD. THE BALANCE OF THE RETURNED DEVICE IS IN FAIRLY GOOD CONDITION DESPITE ITS AGE. THE RELEVANT DRAWING WAS REVIEWED AND DETERMINED TO BE SUITABLE FOR THE INTENDED DESIGN, APPLICATION AND DIMENSIONAL CONFORMITY WHEN USED AS RECOMMENDED. THE CONDITION OF THE RETURNED DEVICE DOES AGREE WITH THE COMPLAINT DESCRIPTION. WHETHER THE COMPLAINT CONDITION FOR THIS DEVICE CAN BE REPLICATED IS NOT APPLICABLE FOR THIS CONDITION. THE RISK ASSESSMENT ADEQUATELY ADDRESSES THE COMPLAINT EVENT. NO NON-CONFORMANCE REPORTS GERMANE TO THE COMPLAINT CONDITION WERE GENERATED DURING THE PRODUCTION OF THIS DEVICE. IT IS LIKELY THAT OVER FIVE YEARS OF USE AND POSSIBLY THE APPLICATION OF EXCESSIVE FORCE DURING SURGERY HAVE LED TO THIS COMPLAINT CONDITION. 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 IS AN INSTRUMENT AND IS NOT IMPLANTED OR EXPLANTED. THE COMPLAINANT PART IS EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION, BUT HAS YET TO BE RECEIVED. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN AS NO PRODUCT WAS RECEIVED. DEVICE HISTORY RECORD REVIEW: MANUFACTURING DATE: OCTOBER 22, 2010. REVIEW OF THE DEVICE HISTORY RECORD SHOWED THAT THERE WERE NO ISSUES DURING THE MANUFACTURE OF THE PRODUCT THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. THE RAW MATERIAL, WHICH WAS DELIVERED AS LOT HB423564, IS CORRESPONDING TO THE SPECIFICATIONS. NO NON-CONFORMANCE REPORTS WERE GENERATED DURING PRODUCTION. SERVICE HISTORY RECORD REVIEW: PART NUMBER - 399.99 / LOT NUMBER: T952323 NO SERVICE HISTORY REVIEW CAN BE PERFORMED AS THIS IS A LOT CONTROLLED ITEM. THE MANUFACTURE DATE OF THIS ITEM IS OCTOBER 25, 2010. THE SOURCE OF THE MANUFACTURE DATE IS THE RELEASE TO WAREHOUSE DATE. CLARIFICATION: THE PART/LOT COMBINATION WAS MANUFACTURED ON OCTOBER 22, 2010, BUT NOT RELEASED TO THE WAREHOUSE FOR DISPENSING UNTIL OCTOBER 25, 2010. AS SUCH, OCTOBER 25, 2010 IS THE DATE REPORTED IN THE FIELD. 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE TIP ON A PAIR OF REDUCTION FORCEPS BROKE OFF WHILE THE SURGEON WAS REDUCING A FIBULA DURING A SURGICAL PROCEDURE ON (B)(6) 2015. THE TIP OF THE INSTRUMENT WAS EASILY RETRIEVED WITH NO DELAY TO SURGERY. THE SURGERY WAS SUCCESSFULLY COMPLETED WITH NO HARM TO PATIENT. THIS REPORT IS 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    789117 REDUCTION FORCEPS WITH SERRATED JAW-RATCHET 144MM FORCEPS HTD SYNTHES TUTTLINGEN T952323

    Patients

    Seq Age Sex Outcome Treatment
    1