BEUDAMED
    FDA Adverse Event Injury Summary report: N

    5.0MM FLEXIBLE SHAFT

    MDR report key: 4564190 · Received March 3, 2015

    Report

    Report Number
    2520274-2015-11404
    Event Type
    Injury
    Date Received
    March 3, 2015
    Date of Event
    February 19, 2015
    Report Date
    February 19, 2015
    Manufacturer
    SYNTHES BETTLACH
    Product Code
    HTO
    PMA / PMN Number
    PEXEMPT
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL NARRATIVE: EXACT WEIGHT REPORTED AS (B)(6). THE DEVICE WAS RECEIVED, THE INVESTIGATION COULD NOT BE COMPLETED, AND NO CONCLUSION COULD BE DRAWN, AS PRODUCT IS ENTERING THE COMPLAINT SYSTEM. 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: A PD INVESTIGATION SUMMARY WAS PERFORMED. THE INVESTIGATION OF THE COMPLAINT ARTICLES HAS SHOWN THAT: THE DEVICES WERE RETURNED AND REPORTED TO HAVE BROKEN DURING SURGERY INSIDE THE PATIENT. THIS CONDITION IS CONFIRMED; ALL FOUR PRONGS OF THE FLEXIBLE SHAFT HAVE BROKEN OFF, THE REAMER HEAD IS MISSING A LARGE CHUNK FROM THE PROXIMAL PORTION OF THE DEVICE, AND THE TIP OF THE REAMING ROD WAS RETURNED HAVING BROKEN APPROXIMATELY 45MM FROM THE DISTAL TIP. IT IS LIKELY THAT THE REAMING ASSEMBLY ENCOUNTERED SIGNIFICANT RESISTANCE WHILE REAMING IN ADDITION TO NUMEROUS YEARS OF USE LEADING TO THIS COMPLAINT CONDITION. THE 352.085 REAMER HEAD WAS MANUFACTURED IN 8/2005 AND IS OVER NINE YEARS OLD. THE 352.040 WAS MANUFACTURED IN 10/2012 AND IS OVER TWO YEARS OLD. 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 COMPLAINT CONDITION FOR THE 352.040 LOT NUMBER 8113661 5.0MM FLEXIBLE SHAFT, 352.085 LOT NUMBER 2143090 MEDULLARY REAMER HEAD, AND 2.5MM REAMING ROD WITH BALL TIP WAS LIKELY CAUSED BY YEARS OF USE AND POSSIBLY DUE TO RESISTANCE ENCOUNTERED WHILE REAMING; HOWEVER, THIS COMPLAINT IS NOT A RESULT OF ANY DESIGN RELATED DEFICIENCY. 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

    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 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. THIS REPORT IS FOR AN UNKNOWN REAMER SHAFT. IMPLANT AND EXPLANT DATES: DEVICE INSTRUMENT AND IS NOT IMPLANTED/EXPLANTED. INVESTIGATION COULD NOT BE COMPLETED AND NO CONCLUSION COULD BE DRAWN AS NO DEVICE WAS RETURNED AND NO LOT NUMBER OR PART NUMBER WAS PROVIDED. 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 A SMALL PART OF THE 8.5MM REAMER HEAD TIP BROKE OFF IN THE TIBIA WITH A PORTION OF THE REAMING ROD. THERE WAS NO DELAY IN THE PROCEDURE. THE PATIENT OUTCOME WAS REPORTED AS SUCCESSFUL.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE REAMER TIP AND SHAFT BROKE OFF INSIDE THE PATIENT. THERE WAS PATIENT INVOLVEMENT AND NO HARM TO THE PATIENT. THIS REPORT IS FOR AN UNKNOWN REAMER SHAFT. THIS REPORT IS 2 OF 2 FOR COMPLAINT (B)(4).

    Description of Event or Problem · 1

    THIS IS REPORT 2 OF 3 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    147042 5.0MM FLEXIBLE SHAFT REAMER HTO SYNTHES BETTLACH 8113661

    Patients

    Seq Age Sex Outcome Treatment
    1 19 YR Required Intervention