BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CANNULATED CONNECTING SCREW F/TROCHANTERIC FIXATION NAILS

    MDR report key: 6255753 · Received January 17, 2017

    Report

    Report Number
    1719045-2017-10026
    Event Type
    Malfunction
    Date Received
    January 17, 2017
    Date of Event
    December 24, 2016
    Report Date
    December 24, 2016
    Manufacturer
    SYNTHES MONUMENT
    Product Code
    FZX
    UDI-DI
    10886982196224
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AK, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). 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

    A PRODUCT DEVELOPMENT INVESTIGATION WAS PERFORMED. MULTIPLE MALFUNCTIONS WERE REPORTED DURING A TROCHANTERIC FIXATION NAIL (TFN) PROCEDURE. THE INSTRUMENTS ARE ROUTINELY USED IN THE TITANIUM TROCHANTERIC FIXATION NAIL SYSTEM. OF THOSE REPORTED, THE FOLLOWING WERE ABLE TO BE CONFIRMED: COUPLING SCREW ¿ 357.377, LOT 5359636, MFG 30-JAN-2007 ¿ BROKEN CAP ¿ 30 MINUTE DELAY - CONFIRMED. BLADE GUIDE SLEEVE ¿ 357.369, LOT 4474601, MFG 22-APR-2003 ¿ STUCK - CONFIRMED. BUTTRESS COMPRESSION NUT - 357.371, LOT 4779621, MFG 13-AUG-2004¿ STUCK ¿ CONFIRMED. HELICAL BLADE INSERTER - 357.372, LOT 4576929, MFG 10-APR-2003 ¿ BROKEN TIP ¿ CONFIRMED. DURING THE INVESTIGATION NO PRODUCT DESIGN ISSUES OR DISCREPANCIES WERE OBSERVED THAT MAY HAVE CONTRIBUTED TO THE COMPLAINT CONDITION. A VISUAL INSPECTION, DEVICE HISTORY RECORD (DHR) REVIEW, MANUFACTURING INVESTIGATION, SERVICE HISTORY REVIEW, AND DRAWING REVIEW WERE PERFORMED AS PART OF THIS INVESTIGATION. THE FOLLOWING DEVICES WERE EXAMINED AND WERE DETERMINED TO BE UNCONFIRMED. ALL OF THE INSTRUMENTS DISPLAYED SIGNIFICANT WEAR AND IMPACT MARKS BUT THE SURFACE DAMAGE WOULD NOT IMPACT THE FUNCTIONALITY OF THE COMPLAINT. THE HELICAL BLADE WAS NOT RETURNED THEREFORE THE DAMAGE COULD NOT BE CONFIRMED. AS THE COMPLAINTS AGAINST THESE DEVICES ARE UNCONFIRMED, A DETAILED COMPLAINT INVESTIGATION INCLUDING A COMPLAINT HISTORY REVIEW AND RISK DOCUMENT REVIEW IS NOT REQUIRED. 130 DEG AIMING ARM - PART 357.366, LOT 4733180, MFG 04-MAR-2004 ¿ BENT ¿ UNCONFIRMED. INSERTION HANDLE ¿ 357.411, LOT 4481673, MFG 20-DEC-2002 ¿ BENT ¿ UNCONFIRMED. CONNECTING SCREW ¿ 357.397, LOT 6921363, MFG 26-JUNE-2012 ¿ BENT ¿ UNCONFIRMED. WIRE GUIDE - 357.381, LOT 4825180, 20-OCT-2004 ¿ BENT ¿ UNCONFIRMED. TROCAR ¿ 357.383, LOT 4464407, MFG 02-OCT-2002 ¿ BENT ¿ UNCONFIRMED. HELICAL BLADE ¿ 465.304 ¿ NICK/GOUGED/CHIPPED ¿ UNCONFIRMED (WAS NOT RETURNED) . RELEVANT DRAWINGS FOR THE RETURNED UNCONFIRMED INSTRUMENTS WERE EXAMINED (BOTH CURRENT REVISION AND FROM THE TIME OF MANUFACTURE). THE DESIGN, MATERIALS AND FINISHING PROCESSES WERE FOUND TO BE APPROPRIATE FOR THE INTENDED USE OF THESE DEVICES. 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

    PATIENT HEIGHT REPORTED AS 5 FEET 4 INCHES. DEVICE IS AN INSTRUMENT AND IS NOT IMPLANTED/EXPLANTED. (B)(4). PART 357.397, LOT 6921363: RELEASE TO WAREHOUSE DATE: JUNE 26, 2012. SUPPLIER: (B)(4). NO NON-CONFORMANCE REPORTS WERE GENERATED DURING PRODUCTION. REVIEW OF DEVICE HISTORY RECORDS SHOWED THAT THERE WERE NO ISSUES DURING THE MANUFACTURE OF THIS PRODUCT THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT AN INITIAL TROCHANTERIC FIXATION NAIL (TFN) PROCEDURE FOR THE LEFT FEMUR TOOK PLACE ON (B)(6) 2016 WHERE SEVERAL DEVICE MALFUNCTIONS OCCURRED. THE HELICAL BLADE COUPLING SCREW BROKE INTO TWO PIECES WHILE BEING HAMMERED BY AN UNKNOWN MALLET. THOSE PIECES WERE RETRIEVED WITH DIFFICULTY AND UNSPECIFIED ADDITIONAL INTERVENTION RESULTING IN A THIRTY (30) MINUTE SURGICAL DELAY. ADDITIONALLY, AS THE HELICAL BLADE INSERTER WAS REMOVED IT WAS NOTED THE TIP WAS BROKEN IN PIECES AS A RESULT FROM THE HAMMERING. ALL PIECES WERE RETRIEVED FROM THE BROKEN INSERTER. IT WAS ALSO DETERMINED THE THREADS OF THE BLADE GUIDE SLEEVE BECAME DAMAGED WHILE THE SURGEON WAS TRYING TO REMOVE THE HELICAL BLADE INSERTER. THE BUTTRESS COMPRESSION NUT FOR THE BLADE GUIDE SLEEVE COULD NO LONGER BE TURNED, AND WAS NO LONGER USABLE BECAUSE OF THE DAMAGE TO THE THREADS. THIS PUSHED THE BLADE GUIDE SLEEVE INTO THE 130 DEGREE AIMING ARM. THE BUTTRESS COMPRESSION NUT AND THE BLADE GUIDE SLEEVE BECAME STUCK TOGETHER. DURING THE IMPLANTATION OF THE HELICAL BLADE AND THE NAIL THE SURGEON REPORTED DIFFICULTY IN IMPLANTING THE TWO DEVICES. A PAIR OF NON-SYNTHES PLIERS WAS USED TO REMOVE THE HELICAL BLADE. THE SURFACE OF THE HELICAL BLADE WAS SCRATCHED WHILE IT WAS BEING REMOVED. THE HELICAL BLADE WAS CONNECTED TO BOTH THE HELICAL BLADE INSERTER AND THE INSERTER COUPLING SCREW; THESE BECAME STUCK TOGETHER FOR A SHORT TIME BUT WERE LATER SEPARATED. THE HELICAL BLADE AND THE NAIL WERE BOTH REMOVED AND REPLACED WITH TWO NEW BACK-UP IMPLANTS OF THE SAME KIND TO COMPLETE THE PROCEDURE. ADDITIONAL DEVICES WERE ALSO DAMAGED DURING THE PROCEDURE: TFN AIMING ARM AND CONNECTING SCREW WERE BENT BY THE MALLET. THE SURGEON HAD CONCERNS THE CONNECTING SCREW MIGHT BE BENT AND COULD NOT BE TIGHTENED CORRECTLY. THE 130 DEGREE AIMING ARM, GUIDE WIRE, AND 4MM TROCAR WERE MOST LIKELY BENT OR DAMAGED AS WELL. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. CONCOMITANT DEVICES REPORTED WERE: NON-SYNTHES PLIERS (PART/LOT UNKNOWN, QUANTITY 1); MALLET, (PART/LOT UNKNOWN, QUANTITY 1); TFN NAIL (PART 456.357S, LOT UNKNOWN, QUANTITY 1). THIS IS REPORT 7 OF 10 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    40804 CANNULATED CONNECTING SCREW F/TROCHANTERIC FIXATION NAILS GUIDE FZX SYNTHES MONUMENT 6921363 10886982196224

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR 1 PART 456.357S, LOT UNKNOWN, TFN NAIL| 1 UNKNOWN MALLET| 1 UNKNOWN PAIR NON-SYNTHES PLIERS