BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AIMING ARM FOR TI CANN HINDFOOT ARTHRODESIS NAIL-EX

    MDR report key: 20044258 · Received August 22, 2024

    Report

    Report Number
    8030965-2024-10269
    Event Type
    Malfunction
    Date Received
    August 22, 2024
    Date of Event
    July 26, 2024
    Manufacturer
    SYNTHES GMBH
    Product Code
    FZX
    UDI-DI
    10886982066886
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    DEPUY SYNTHES IS SUBMITTING THIS REPORT PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH DEPUY SYNTHES HAS NOT BEEN ABLE TO INVESTIGATE OR VERIFY PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY FDA, DEPUY SYNTHES OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE DEVICE, DEPUY SYNTHES, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. IF THE INFORMATION IS UNKNOWN, NOT AVAILABLE OR DOES NOT APPLY, THE SECTION/FIELD OF THE FORM IS LEFT BLANK. H11 ADDITIONAL NARRATIVE: E3: REPORTER IS A J&J SALES REPRESENTATIVE. H6: THE SUBJECT DEVICE HAS BEEN RECEIVED, THE INVESTIGATION IS IN PROGRESS, NO CONCLUSION COULD BE DRAWN AT THE TIME OF FILING THIS REPORT. H6: PHOTO INVESTIGATION: THE PHOTOGRAPHS PROVIDED WERE REVIEWED, HOWEVER THE PROVIDED EVIDENCE WAS NOT SUFFICIENT TO CONFIRM THE REPORTED EVENT OF MISALIGNMENT. FUNCTIONALITY ISSUES CANNOT BE EVALUATED THROUGH A PHOTO INVESTIGATION. THE OVERALL COMPLAINT WAS UNCONFIRMED AS THE PHOTOGRAPHS PROVIDED DON¿T HAVE ANY EVIDENCE TO DRAW A CONCLUSION ABOUT THE REPORTED EVENT. BASED ON THE INVESTIGATION FINDINGS, IT HAS BEEN DETERMINED THAT NO CORRECTIVE AND/OR PREVENTATIVE ACTION IS PROPOSED. THERE IS NO INDICATION THAT A DESIGN OR MANUFACTURING ISSUE HAS CAUSED THE COMPLAINT CONDITION. AS PART OF DEPUY SYNTHES QUALITY PROCESS, ALL DEVICES ARE MANUFACTURED, INSPECTED, AND RELEASED TO APPROVED SPECIFICATIONS. ADDITIONAL MONITORING FOR ANY POTENTIAL SAFETY SIGNALS WILL BE CONDUCTED THROUGH COMPLAINT TRENDING AND OTHER POST-MARKET SAFETY SURVEILLANCE ACTIVITIES. H3, H4, H6: DEVICE HISTORY RECORD (DHR) REVIEW CONDUCTED: PART: 03.008.009. LOT NO: 3101387. RELEASE TO WAREHOUSE DATE: 18 MAY, 2009. MANUFACTURING SITE: WERK HAGENDORF. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED ARTICLE LOT AND NO NON-CONFORMANCES WERE IDENTIFIED. 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 · 0

    DEPUY SYNTHES IS SUBMITTING THIS REPORT PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH DEPUY SYNTHES HAS NOT BEEN ABLE TO INVESTIGATE OR VERIFY PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY FDA, DEPUY SYNTHES OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE DEVICE, DEPUY SYNTHES, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. PHYSICAL DEVICE INVESTIGATION:: H3, H4, H6: THE PRODUCT WAS RETURNED TO DEPUY SYNTHES FOR EVALUATION. VISUAL INSPECTION OF THE RETURNED DEVICE FOUND NOTHING INDICATIVE OF A DEVICE NONCONFORMANCE. ALL THE HOLES IN THE DEVICE WERE OBSERVED IN NORMAL CONDITIONS. NO SIGNS OF HEAVY USE WERE IDENTIFIED. A DIMENSIONAL INSPECTION WAS UNABLE TO BE PERFORMED DUE TO THE POST-MANUFACTURING DAMAGE. A FUNCTIONAL EVALUATION WAS NOT PERFORMED SINCE THE MATING DEVICES LIKE THE PROTECTION SLEEVE (03.008.002), THREADED ALIGNMENT PIN (03.008.004), DRILL SLEEVE (03.010.069) Y GUIDE WIRE (357.399) WERE NOT RETURNED. THEREFORE THE COMPLAINT CANNOT BE REPLICATE. ACCORDING TO THE SURGICAL TECHNIQUE EXPERT HAN. EXPERT HINDFOOT ARTHRODESIS NAIL, THE FOLLOWING STEPS MUST FOLLOW, TO CONFIRM THE NAIL AND SCREW POSITION THE FOLLOWING STEP. INSERT THE ALIGNMENT PIN INTO THE AIMING ARM ATTACH THE AIMING ARM TO THE INSERTION HANDLE. ORIENT THE AIMING ARM SO THE LETTER ¿P¿, FOR POSTERIOR, CAN BEEN SEEN ON THE INSERTION HANDLE. TIGHTEN THE THREADED ALIGNMENT PIN. INSERT TROCAR COMBINATION INSERT THE THREE-PART TROCAR COMBINATION (PROTECTION SLEEVE, CORRESPONDING DRILL SLEEVE AND TROCAR) THROUGH THE MOST INFERIOR HOLE OF THE AIMING ARM. MAKE A STAB INCISION AND INSERT THE TROCAR TO THE BONE. REMOVE THE TROCAR. VERIFY NAIL INSERTION DEPTH AND LOCATION BY INSERTING A 400 MM GUIDE WIRE THROUGH THE DRILL SLEEVE INTO THE BONE. CONFIRM GUIDE WIRE POSITION RADIOGRAPHICALLY. THIS POSITION WILL DETERMINE THE FINAL POSITION OF THE MOST DISTAL LOCKING SCREW THE OVERALL COMPLAINT WAS NOT CONFIRMED AS THE OBSERVED CONDITION OF THE AIM ARM FOR TI CANN HINDFOOT ARTHRO NL WOULD NOT CONTRIBUTE TO THE COMPLAINED DEVICE ISSUE. BASED ON THE INVESTIGATION FINDINGS, IT HAS BEEN DETERMINED THAT NO CORRECTIVE AND/OR PREVENTATIVE ACTION IS PROPOSED. THERE IS NO INDICATION THAT A DESIGN OR MANUFACTURING ISSUE HAS CAUSED THE REPORTED COMPLAINT CONDITION. AS PART OF DEPUY SYNTHES QUALITY PROCESS, ALL DEVICES ARE MANUFACTURED, INSPECTED, AND RELEASED TO APPROVED SPECIFICATIONS. ADDITIONAL MONITORING FOR ANY POTENTIAL SAFETY SIGNALS WILL BE CONDUCTED THROUGH COMPLAINT TRENDING AND OTHER POST-MARKET SAFETY SURVEILLANCE ACTIVITIES. DEVICE HISTORY REVIEW (DHR) PART:03.008.009, LOT:3101387, MANUFACTURING SITE: WERK HAGENDORF, SUPPLIER: NA, RELEASE TO WAREHOUSE DATE: 18 MAY 2009, EXPIRATION DATE: NA. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED ARTICLE LOT AND NO NON-CONFORMANCES WERE IDENTIFIED. 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 · 0

    IT WAS REPORTED THAT ON JULY 26, 2024, THE TARGETING HOLES WERE NOT LINING UP WITH THE NAIL. THERE WAS NO PATIENT INVOLVEMENT. THIS REPORT IS FOR ONE (1) AIMING ARM FOR TI CANN HINDFOOT ARTHRODESIS NAIL-EX. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1741858 AIMING ARM FOR TI CANN HINDFOOT ARTHRODESIS NAIL-EX GUIDE, SURGICAL, INSTRUMENT FZX SYNTHES GMBH 3101387 10886982066886

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown UNK TI CANN HINDFOOT ARTHRODESIS NAIL-EX