BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    11.5MM/8.5MM PROTECTION SLEEVEFOR RECON LOCKING

    MDR report key: 5943713 · Received September 12, 2016

    Report

    Report Number
    1719045-2016-10679
    Event Type
    Malfunction
    Date Received
    September 12, 2016
    Date of Event
    August 19, 2016
    Report Date
    August 22, 2016
    Manufacturer
    SYNTHES MONUMENT
    Product Code
    FZX
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SD, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    AN INVESTIGATION SUMMARY WAS PERFORMED. THE INVESTIGATION OF THE COMPLAINT ARTICLES HAS SHOWN THAT: A VISUAL INSPECTION, DEVICE HISTORY REVIEW (DHR), COMPLAINT HISTORY REVIEW, DRAWING REVIEW, AND RISK ASSESSMENT REVIEW WERE PERFORMED AS PART OF THIS INVESTIGATION. THE COMPLAINT WAS ONLY ABLE TO BE CONFIRMED FOR THE DRIVING CAP AS THE PART WAS RETURNED WITH THE DISTAL THREADS BROKEN OFF AND LODGED IN THE INSERTION HANDLE. REPLICATION OF THE COMPLAINT IS NOT APPLICABLE AS THE DRIVING CAP WAS RETURNED BROKEN. THE DRIVING CAP ALSO SHOWED SIGNS OF WEAR AND IMPACTION ALONG THE SHAFT AND PROXIMAL END. ALTHOUGH THE EXACT CAUSE FOR THE COMPLAINT CONDITION COULD NOT BE DETERMINED, THE DAMAGE TO THE DRIVING CAP IS MOST LIKELY THE RESULT OF OFF-AXIS HAMMERING ON THE DEVICE BEFORE FULLY SEATING THE DRIVING CAP ON THE INSERTION HANDLE OR FROM CROSS THREADING THE DEVICE. THE COMPLAINT AGAINST THE INSERTION HANDLE (03.010.486) IS UNCONFIRMED AS THE ALLEGATION OF DEFICIENCY IS AGAINST THE BROKEN DRIVING CAP.01SEP2016: ALL DEVICES HAVE BEEN RECEIVED WITH THE EXCEPTION OF THE REPAIRABLE AIMING ARM. PLEASE NOTE THAT THE SECOND PROTECTION SLEEVE (03.010.075) WAS NOT RETURNED AND WAS REPORTED TO HAVE BEEN DISCARDED. THE RETURNED PROTECTION SLEEVE (03.010.075, LOT 068672) AND AIMING ARM (03.010.048) WERE FUNCTIONALLY TESTED AND FOUND TO FIT AS INTENDED. THE DEVICES WERE MEASURED AND FOUND TO BE IN SPEC OF THEIR RESPECTIVE DRAWINGS. AN INVESTIGATION WILL BE PERFORMED ON THIS PART SHOULD THE PART RETURN FOR EVALUATION. 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. DEVICE IS AN INSTRUMENT AND IS NOT IMPLANTED/EXPLANTED. A DEVICE HISTORY RECORD REVIEW WAS PERFORMED. SUPPLIER LOT NUMBER: 068672 IS COMPOSED OF TWO SYNTHES LOT NUMBERS: 5814883, 5822273. THE SYNTHES LOT NUMBER FOR THIS COMPLAINED DEVICE IS UNKNOWN AT THIS TIME. LOT# 5814883: THE DEVICE HISTORY RECORD REVIEW SHOWED THAT THERE WERE NO ISSUES DURING THE MANUFACTURE OF THE PRODUCT THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. NO NON-CONFORMANCES WERE GENERATED DURING THE PRODUCTION OF LOT# 5814883. LOT# 5822273: THE DEVICE HISTORY RECORD REVIEW SHOWED A NON-CONFORMANCE WAS ISSUED. OF 10 ITEMS, ONE ITEM WAS SCRAPPED DURING INCOMING FINAL INSPECTION AS IT FAILED GAGE CHECK. IT WOULD NOT GO INTO THE RELEVANT GAGE. RELEVANCE TO THE COMPLAINT CONDITION CANNOT BE DETERMINED UNTIL THE PRODUCT IS INVESTIGATED. REVIEW OF DEVICE HISTORY RECORDS SHOWED THAT THERE ARE POTENTIAL ISSUES DURING THE MANUFACTURE OF THE PRODUCT THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. THE SUBJECT DEVICE HAS BEEN RECEIVED. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS THE SUBJECT DEVICE IS ENTERING THE COMPLAINT SYSTEM. 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 DURING SURGERY FOR A LEFT FEMUR FRACTURE ON (B)(6) 2016, THERE WERE SEVERAL ISSUES THAT OCCURRED WITH THE INSTRUMENTATION. WHILE THE SURGEON WAS INSERTING THE FEMORAL NAIL, THE THREADS OF THE DRIVING CAP BROKE OFF AND REMAIN IN THE INSERTION HANDLE. IN ORDER FOR THE SURGEON TO ADVANCE THE NAIL FURTHER, HE USED PART OF THE APPARATUS AS A HAMMER TO COMPLETE THE TASK. THE SECOND ISSUE INVOLVED THE AIMING ARM. IT WAS REPORTED THAT THE PERCUTANEOUS SLEEVES WOULD NOT SLIDE THROUGH THE AIMING ARM AFTER THE NAIL WAS INSERTED. THE SURGEON USED A MALLET TO HIT THE SLEEVES TO GO THROUGH THE AIMING ARM. THERE WERE TWO SETS OF SLEEVES THAT WERE USED, ONE SET BECAME BENT AND WAS DISCARDED. THERE WAS A SURGICAL DELAY OF APPROXIMATELY 30 MINUTES DUE TO BOTH ISSUES. THE REMAINDER OF THE SURGERY WENT WITHOUT FURTHER INCIDENT AND THE PATIENT WAS REPORTED AS STABLE. THE PATIENT WAS IMPLANTED WITH A LATERAL ENTRY FEMORAL NAIL AND A DISTAL LOCKING SCREW. IT IS UNKNOWN IF OTHER DEVICES WERE IMPLANTED. CONCOMITANT DEVICES: WIRE GUIDE FOR RECON LOCKING (PART #03.010.076, LOT #066895, QUANTITY TROCAR FOR RECON LOCKING (PART #03.010.077, LOT #068341, QUANTITY (B)(4)); FEMORAL NAIL (PART # UNKNOWN, LOT # UNKNOWN, QUANTITY (B)(4)). THIS REPORT IS 2 OF 3 FOR COMPLAINT# (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    594846 11.5MM/8.5MM PROTECTION SLEEVEFOR RECON LOCKING GUIDE FZX SYNTHES MONUMENT 068672

    Patients

    Seq Age Sex Outcome Treatment
    1 14 YR 1 X FEMORAL NAIL (PART # UNKNOWN, LOT # UNKNOWN)| 1 X TROCAR (PART #03.010.077, LOT #068341)| 1 X WIRE GUIDE (PART #03.010.076, 066895)