BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    11.5MM/8.5MM PROTECTION SLEEVE FOR RECON LOCKING

    MDR report key: 6546356 · Received May 4, 2017

    Report

    Report Number
    1719045-2017-10435
    Event Type
    Malfunction
    Date Received
    May 4, 2017
    Date of Event
    April 9, 2017
    Report Date
    April 9, 2017
    Manufacturer
    SYNTHES MONUMENT
    Product Code
    FZX
    UDI-DI
    10886982067456
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    A PRODUCT DEVELOPMENT INVESTIGATION WAS PERFORMED. THE FOLLOWING EIGHT (8) DEVICES WERE RECEIVED WITH SURFACE WEAR CONSISTENT WITH THE AGE OF EACH DEVICE (APPROX. 6.5 TO 12.5 YEARS OLD) AND SIGNIFICANT USE AND WITH THE COMPLAINT CATEGORY OF DEVICE INTERACTION: MISALIGNMENT: TWO (2) PROTECTION SLEEVES FOR RECON LOCKING (PART 03.010.075, LOTS 32739), TWO (2) WIRE GUIDES FOR RECON LOCKING (PART 03.010.076, LOTS 34696), TWO (2) 3.2MM TROCARS FOR RECON LOCKING (PART 03.010.077, LOT 37870) , ONE (1) RECON LOCKING AIMING ARM (PART 03.010.048, LOT 4944751), ONE (1) INSERTION HANDLE (PART 03.010.046, LOT 3449695). A DEVICE HISTORY RECORD REVIEW, DEVICE INSPECTION, FUNCTIONAL TEST, AND DRAWING REVIEW WERE PERFORMED AS PART OF THIS INVESTIGATION. THE RETURNED PARTS WERE DETERMINED TO BE SUITABLE FOR THEIR INTENDED USE WHEN EMPLOYED AND MAINTAINED AS RECOMMENDED. NO NEW MALFUNCTIONS WERE OBSERVED DURING THE COURSE OF THIS INVESTIGATION. THE RETURNED DEVICES ARE PART OF THE TITANIUM CANNULATED LATERAL ENTRY FEMORAL NAIL SYSTEM AND ARE SPECIFICALLY USED IN TARGETING WHEN THE TWO RECON LOCKING SCREWS OPTION IS DESIRED. THE ASSOCIATED NAIL WAS NOT RETURNED; THEREFORE TESTING WITH THE NAIL IN QUESTION WAS UNABLE TO BE PERFORMED. HOWEVER, DURING FUNCTIONAL TESTING THE DEVICES COULD BE FULLY ASSEMBLED AND FORMED A RIGID CONSTRUCT AS INTENDED. IN ADDITION, THE DEVICES WERE FOUND TO NOT SHOWS ANY DEFECTS WHICH WOULD CONTRIBUTE TO THE COMPLAINT CONDITION. THE OBSERVED SURFACE WEAR WAS DETERMINED NOT IMPACT FUNCTIONALITY. THUS, THE REPORTED ISSUE THAT THE AIMING APPARATUS WAS ¿FLIMSY¿ IS UNCONFIRMED. IT WAS REPORTED THAT THE SURGEON WAS ABLE TO MANIPULATE THE APPARATUS USING HIS HANDS TO GET THE TROCAR COMBINATION TO LINE UP APPROPRIATELY AND IMPLANT THE RECON SCREWS AND THAT THE NAIL WAS SUCCESSFULLY IMPLANTED. THIS SPEAKS TO THE LIKELIHOOD THAT THE DEVICES WERE NOT FULLY TIGHTENED AS INTENDED OR THAT SOFT TISSUE DEFLECTION FORCES WERE PRESENT WHICH WOULD BOTH IMPACT THE ALIGNMENT. MATERIAL RECORD REVIEW (MRR) WAS GENERATED FOR PART 03.010.075, LOT 32739 FOR AN UNDERSIZED INNER SHAFT AND FOR TRUE POSITION GAGE. THIS IS NOT RELATED TO THE COMPLAINT CONDITION BECAUSE ACCORDING TO THE COMPLAINT DESCRIPTION, SURGEON WAS ABLE TO MANIPULATE THE APPARATUS USING HIS HANDS TO GET THE TROCAR COMBINATION TO LINE UP AND A TRUE POSITION BEING OFF WOULD NOT BE ABLE TO BE MANUALLY MANIPULATED (METAL PROPERTIES/TRUE POSITION UNABLE TO BE MANIPULATED BY HAND). THE LOT WAS 100 PERCENT INSPECTED AND THE 3 NON-CONFORMING ITEMS WERE RETURNED TO SUPPLIER. RELEVANT DRAWINGS, REFLECTING THE CURRENT AND MANUFACTURED REVISION, WERE REVIEWED. THE RECON LOCKING PROTECTION SLEEVE HOLES OF THE AIMING ARE WERE INSPECTED AND CONFIRMED TO BE WITHIN THE SPECIFICATION. IN CONCLUSION, AS NO FUNCTIONAL ISSUE WAS IDENTIFIED, THE COMPLAINT CONDITION FOR THESE DEVICES IS UNCONFIRMED AND COULD NOT BE REPLICATED. DURING THE INVESTIGATION THERE IS NO EVIDENCE OF A MANUFACTURING ISSUE AND NO PRODUCT DESIGN ISSUES OR DISCREPANCIES WERE OBSERVED THAT MAY HAVE CONTRIBUTED TO THE COMPLAINT CONDITION. THE RETURNED PARTS WERE DETERMINED TO BE SUITABLE FOR THEIR INTENDED USE WHEN EMPLOYED AND MAINTAINED AS RECOMMENDED. 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/EXPLANTED. THE DEVICE WAS RECEIVED, THE INVESTIGATION COULD NOT BE COMPLETED, AND NO CONCLUSION COULD BE DRAWN, AS PRODUCT IS ENTERING THE COMPLAINT SYSTEM. DHR REVIEW FOR PART: #03.010.075 -SYNTHES LOT #4791742, SUPPLIER LOT # 32739, RELEVANCE TO COMPLAINT CONDITION CANNOT BE DETERMINED UNTIL THE PRODUCT IS RETURNED FOR INVESTIGATION. (B)(6) CONSISTED OF 60 ITEMS WITH THE INNER SHAFT DIAMETER AND 3 ITEMS WITH POSITION GAGE OUT OF SPECIFICATIONS. THE SLIGHT UNDERSIZE CAUSE MINOR RUBBING WITH MATING DRILL BUT NO ISSUES WITH FUNCTION. THE REVIEW OF THE DEVICE HISTORY RECORDS(S) SHOWED THAT THERE ARE POTENTIAL ISSUES DURING MANUFACTURE OF THE PRODUCT WHAT COULD CONTRIBUTE TO THIS COMPLAINT CONDITION. RELEASE TO WAREHOUSE DATE: 03AUG2004. SUPPLIER: PRECISION EDGE SURGICAL PRODUCTS. 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 THREE-PART TROCAR COMBINATION WHICH CONSISTED OF THE PROTECTION SLEEVES, WIRE GUIDES, AND TROCARS WAS NOT LINING UP APPROPRIATELY WITH THE HOLES IN THE TITANIUM (TI) LATERAL ENTRY FEMORAL RECON NAIL-EXPERT. PATIENT UNDERWENT A LATERAL ENTRY FEMORAL NAIL PROCEDURE FOR A LEFT FEMUR FRACTURE ON (B)(6) 2017. SURGEON REPORTED THAT HE WAS UNABLE TO ACCURATELY DRILL THE HOLES FOR THE TWO TI RECON SCREWS. IN ADDITION, SURGEON STATED THAT THE AIMING APPARATUS WHICH CONSISTED OF THE AIMING ARM AND INSERTION HANDLE WAS FLIMSY. SURGEON WAS ABLE TO MANIPULATE THE APPARATUS USING HIS HANDS TO GET THE TROCAR COMBINATION TO LINE UP APPROPRIATELY AND IMPLANT THE RECON SCREWS. ADDITIONAL X-RAYS WERE TAKEN TO GET A BETTER VIEW OF THE ISSUE. X-RAYS ARE NOT AVAILABLE FOR REVIEW. PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT REQUIRING OTHER MEDICAL INTERVENTION. THERE WAS AN APPROXIMATELY 30 SECONDS TO ONE MINUTE SURGICAL DELAY DUE TO IDENTIFYING THE ISSUE, MULTIPLE FAILED ATTEMPTS, AND HAND MANIPULATION. PATIENT STATUS/OUTCOME WAS REPORTED AS STABLE. CONCOMITANT DEVICES REPORTED: TI LATERAL ENTRY FEMORAL NAIL (PART 04.003.275S, LOT H210044, QUANTITY 1); TI RECON SCREW (PART 04.003.028, LOT NUMBER UNKNOWN, QUANTITY 2), DRILL BIT (PART 03.010.078, LOT NUMBER UNKNOWN, QUANTITY 1). THIS REPORT IS FOR ONE (1) PROTECTION SLEEVE THIS IS REPORT 2 OF 5 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    326300 11.5MM/8.5MM PROTECTION SLEEVE FOR RECON LOCKING GUIDE FZX SYNTHES MONUMENT 32739 10886982067456

    Patients

    Seq Age Sex Outcome Treatment
    1 19 YR DRILL BIT (03.010.078, LOT UNKNOWN, QTY 1)| SCREW (04.003.028, LOT UNKNOWN, QTY 2)