BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SMARTNAIL DIAMETER 1.5 X 16MM

    MDR report key: 3367195 · Received September 25, 2013

    Report

    Report Number
    9613278-2013-00002
    Event Type
    Injury
    Date Received
    September 25, 2013
    Date of Event
    August 27, 2013
    Report Date
    September 6, 2013
    Manufacturer
    CONMED LINVATEC BIOMATERIALS
    Product Code
    MAI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE TWO(2) SMARTNAILS WERE NOT RETURNED FOR EVALUATION. LOT# S0005521 WAS MANUFACTURED ON 10/04/2012. OF THE LOT CONTAINING (B)(4) UNITS, THERE ARE NO OTHER COMPLAINTS FOR THIS ITEM AND LOT NUMBER COMBINATION. IN ADDITION, NO ANOMALIES WERE NOTED DURING MANUFACTURING. A TWO YEAR REVIEW OF COMPLAINT HISTORY FOR THIS PRODUCT SHOWED TWO (2) COMPLAINTS FOR THIS FAILURE (DIFFERENT LOTS, SAME PROCEDURE AND SAME PATIENT). A TWO YEAR REVIEW OF COMPLAINT HISTORY FOR THIS AND SIMILAR PRODUCT WAS PERFORMED, AND WAS EVALUATED "AS LOW AS REASONABLY POSSIBLE". LOT# S0005486 WAS MANUFACTURED ON 09/04/2012. OF THE LOT CONTAINING (B)(4) UNITS, THERE ARE NO OTHER COMPLAINTS FOR THIS ITEM AND LOT NUMBER COMBINATION, AND NO ANOMALIES WERE NOTED DURING MANUFACTURING. A TWO YEAR REVIEW OF COMPLAINT HISTORY FOR THIS PRODUCT SHOWED TWO (2) COMPLAINTS FOR THIS FAILURE (DIFFERENT LOTS, SAME PROCEDURE AND SAME PATIENT). A TWO YEAR REVIEW OF COMPLAINT HISTORY FOR THIS AND SIMILAR PRODUCT WAS PERFORMED, AND WAS EVALUATED "AS LOW AS REASONABLY POSSIBLE". BASED ON THE REPORTED INFORMATION (WHICH DID NOT INDICATE THE PATIENT WAS EXPERIENCING ANY UNUSUAL POST-OPERATIVE PAIN OR COMPLICATION), AND INFORMATION CONTAINED WITHIN THE PRODUCT'S INSTRUCTIONS FOR USE (IFU) DESCRIPTION SECTION, WHICH STATES: AS THE PATIENT'S BONE GAINS STRENGTH DURING HEALING (APPROXIMATELY 12 WEEKS), THE SMARTNAIL GRADUALLY LOSES ITS STRENGTH, AND ABSORPTION FOLLOWS IMPLANT STRENGTH LOSS. THERE IS NO INDICATION THAT THE SMARTNAILS WERE DEFECTIVE AND/OR DID NOT PERFORM AS INTENDED. THE PRODUCT'S INSTRUCTIONS FOR USE (IFU) PROVIDES THE FOLLOWING WARNINGS AND PRECAUTIONS: THE SMARTNAIL® IMPLANT SHOULD ONLY BE USED WITH THE DESIGNATED SURGICAL INSTRUMENTS AS OUTLINED ABOVE. INSTRUMENTS ARE COLOR CODED TO HELP IDENTIFICATION. IT IS IMPORTANT THAT THE NAIL IS INSERTED WITH THE INDICATED K-WIRE. PREMATURE BENDING, LOOSENING, FRACTURE OR MIGRATION OF THE NAILS MAY RESULT FROM EARLY STRESS AND ACTIVITY. APPROPRIATE IMMOBILIZATION/CONTROLLED MOBILIZATION SHOULD BE USED UNTIL CLINICAL DETERMINATION OF HEALING. A SURGEON MUST GIVE THE PATIENT APPROPRIATE INSTRUCTIONS FOR POST-OPERATIVE CARE AND REHABILITATION IN ORDER TO PREVENT PREMATURE LOAD BEARING AND OTHER COMPLICATIONS. ANY DECISION TO REMOVE THE DEVICE SHOULD TAKE INTO CONSIDERATION THE POTENTIAL RISK TO THE PATIENT OF A SECOND SURGICAL PROCEDURE. SMARTNAIL REMOVAL SHOULD BE FOLLOWED BY ADEQUATE POSTOPERATIVE MANAGEMENT. PRODUCT NOT RETURNED FOR EVALUATION.

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING FILED TO PROVIDE ADDITIONAL INFORMATION REGARDING THE EVENT AND THE EVALUATION OF THE SMARTNAILS THAT WERE RECEIVED AFTER THE INITIAL VERBAL REPORT THAT WAS FILED ON 9/25/2013. ALTHOUGH THE REPORT ALLEGES THAT ONLY TWO (2) SMARTNAILS WERE ELEVATED AND SUBSEQUENTLY REMOVED, SIX (6) UNITS WERE RETURNED FOR EVALUATION. NO ALLEGATIONS WERE REPORTED FOR THE ADDITIONAL FOUR (4) UNITS. THE DEVICES WERE RETURNED/EVALUATED AT CONMED LINVATEC, LARGO ON 10/14/2013 AND PHOTOS WERE PROVIDED TO THE BIOMATERIALS R&D MANAGER IN FINLAND FOR FURTHER ANALYSIS. ADDITIONAL INFORMATION RECEIVED ON 11/7/13 REGARDING THE EVENT: THE SURGEON USED DIFFERENT K-WIRES, NOT THE ORIGINALS. THEREFORE, THEY CANNOT MEASURE THE HOLE TO PROPER DEPTH WITH THE WIRES. SO, IT IS NOT GUARANTEED THAT THE HOLE HAS THE PROPER DEPTH. BASED ON NEW INFORMATION AND THE CONDITION OF THE RETURNED SMARTNAILS, CONMED LINVATEC BIOMATERIALS R&D MANAGER FOUND THAT; IF IT IS REALLY TWO (2) OF THE SMARTNAILS THAT WERE ELEVATED (ALTHOUGH SIX WERE RETURNED), IT SEEMS THAT THE DRILL HOLES IN CASE OF THE TWO NAILS THAT WERE FLATTENED WERE TOO LOW. THE DAMAGED (FLATTENED) TIPS OF THE TWO NAILS WERE PROBABLY CAUSED BY TOO LOW OF A DRILL HOLES, WHICH WOULD EVENTUALLY BE THE REASON FOR THE NAIL'S ELEVATION AS WELL. THE ELEVATION MIGHT HAVE NOT HAPPENED IMMEDIATELY AFTER INSERTION, BUT SOMETIME LATER CAUSED BY INTERNAL TENSION. THE ROOT CAUSE OF THIS EVENT IS MOST LIKELY USER RELATED, AND THE DECISION TO ROUTINELY PERFORM "2ND LOOK ARTHROSCOPIES" ON ALL OF THE PATIENTS IS CONSIDERED A SURGEON'S PREFERENCE. THE PRODUCT'S INSTRUCTIONS FOR USE (IFU) PROVIDES THE FOLLOWING WARNINGS AND PRECAUTIONS: THE SMARTNAIL® IMPLANT SHOULD ONLY BE USED WITH THE DESIGNATED SURGICAL INSTRUMENTS. INSTRUMENTS ARE COLOR CODED TO HELP WITH IDENTIFICATION. IT IS IMPORTANT THAT THE NAIL IS INSERTED WITH THE INDICATED K-WIRE. THIS EVENT DID NOT INVOLVE A PRODUCT PROBLEM INDICATING A NONCONFORMITY, ADVERSE TREND OR UNANTICIPATED HAZARD. NO FURTHER ACTION IS PLANNED AT THIS TIME.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT ON (B)(6) 2013, DURING A 2ND LOOK ARTHROSCOPY THREE (3) MONTHS AFTER IMPLANTING TWO (2) SMARTNAILS FOR FIXATION OF A CHONDRAL GRAFT, THE DOCTOR FOUND THE SMARTNAILS SLIGHTLY ELEVATED (UNDER 1MM). THE SURGEON ELECTED TO REMOVE THE IMPLANTS AS HE FELT THE SMARTNAILS COULD POSSIBLY "MOVE AROUND IN THE JOINT BY THEMSELVES AND CAUSE DAMAGE". THE SURGEON ALSO REPORTED THAT THERE WAS "NO SERIOUS PATIENT OUTCOME, SINCE THE CARTILAGE DEFECT WAS NICELY COVERED BY NEWLY FORMED CARTILAGE TISSUE". THERE WAS NO INDICATION THAT A PROBLEM OCCURRED DURING INITIAL IMPLANTATION; HOWEVER, IT WAS REPORTED THAT THE SURGEON DOES NOT LIKE TO USE THE RECOMMENDED K-WIRES, WHICH ARE REFERENCED IN THE PRODUCT'S INSTRUCTIONS FOR USE (IFU). IN ADDITION, THERE WAS NO REPORT OF POST OPERATIVE COMPLICATIONS THAT PROMPTED THE SECONDARY ARTHROSCOPY. IT WAS ONLY REPORTED THAT: "THIS DOCTOR ROUTINELY PERFORMS 2ND LOOK ARTHROSCOPIES ON ALL OF HIS PATIENTS."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    484269 SMARTNAIL DIAMETER 1.5 X 16MM FASTENER, FIXATION, BIODEGRADABLE, SOFT TISSUE MAI CONMED LINVATEC BIOMATERIALS 531516 S0005521

    Patients

    Seq Age Sex Outcome Treatment
    1 Other ITEM# 531516, SMARTNAIL 1.5 X 16MM, LOT# S0005486