BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EXPERT A2FN NAIL 12 R CANN L400 TAN LIG

    MDR report key: 10496749 · Received September 4, 2020

    Report

    Report Number
    8030965-2020-06626
    Event Type
    Malfunction
    Date Received
    September 4, 2020
    Date of Event
    August 11, 2020
    Report Date
    August 11, 2020
    Manufacturer
    OBERDORF SYNTHES PRODUKTIONS GMBH
    Product Code
    KTT
    UDI-DI
    07611819324411
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MY
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    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. INVESTIGATION SUMMARY INVESTIGATION SITE: CUSTOMER QUALITY (CQ) ZUCHWIL, SELECTED FLOW: DAMAGED: VISUAL / EXAMPLES: DEFORMED/BENT/CRACKED/BROKEN. VISUAL INSPECTION: ONE PRONG OF THE INSERTION HANDLE INTERFACE IS CRACKED AT THE CROSSOVER TO THE NAIL AND STRONGLY BENT OUTWARD. THERE ARE EXCESSIVE STRESS MARKS AT THE INSIDE OF THE DEFORMED PRONG VISIBLE. ALSO ON TOP OF THE INTACT PRONG ARE STRONG STRESS MARKS VISIBLE. OTHERWISE IS THE NAIL IN A GOOD CONDITION WITH NO VISIBLE DAMAGES. DIMENSIONAL INSPECTION: CHECKED DIMENSIONS WITH CALIPER 3-01-20766 PER DRAWING: OUTER DIAMETER AT INSERTION HANDLE INTERFACE SPECIFICATION /MEASURED: = PASS . OUTER DIAMETER AT INSERTION HANDLE INTERFACE SPECIFICATION / MEASURED: = PASS . DEPTH OF INSERTION HANDLE INTERFACE DIAMETER SPECIFICATION / MEASURED: = PASS . THE DIMENSIONS OF THE SLOT CANNOT BE VERIFIED ANYMORE DUE TO THE DAMAGE IN THE AREA OF THIS FEATURE. DOCUMENT/SPECIFICATION REVIEW: DRAWING WAS REVIEWED TO VERIFY THE RELEVANT DIMENSIONS OF THE DEVICE. THE REVIEW HAS SHOWN THAT THIS DRAWING VERSION IS IN PLACE SINCE APRIL 2008, WHICH SPEAKS AGAINST A DESIGN RELATED ISSUE. THE EXPERT A2FN SURGICAL TECHNIQUE (036.000.752 DSEM/TRM/1015/0537(2) 12/17) WAS REVIEWED AND FOLLOWING POTENTIALLY RELEVANT SECTIONS CAN BE POINTED OUT: ASSEMBLE INSERTION INSTRUMENTS PRECAUTION: CHECK THAT THE CONNECTING SCREW IS CORRECTLY TIGHTENED. DO NOT OVER-TIGHTEN. INSERT NAIL USE SLIGHT TWISTING MOTIONS TO ADVANCE THE NAIL. MONITOR NAIL PASSAGE ACROSS THE FRACTURE, AND CONTROL IN TWO PLANES TO AVOID MALALIGNMENT. THE NAIL ROTATES APPROXIMATELY 90° DURING INSERTION. THE INSERTION HANDLE ROTATES FROM ANTERIOR TO LATERAL DURING INSERTION OF THE LAST ONE-THIRD OF THE NAIL LENGTH. IF THE NAIL DOES NOT ROTATE TO THE LATERAL POSITION DURING INSERTION, REMOVE THE NAIL AND REINSERT. OPTIONAL INSTRUMENTS IF NECESSARY, USE LIGHT HAMMER BLOWS TO INSERT THE NAIL. SLIDE THE CONNECTOR INTO THE MEDIAL GROOVES ON THE INSERTION HANDLE (USE THE LATERAL POSITION ONLY WHEN THE PATIENT ANATOMY REQUIRES THIS) AND SECURE IT IN PLACE USING THE COMBINATION WRENCH. NOTES: IF NAIL INSERTION IS DIFFICULT, CHOOSE A SMALLER DIAMETER NAIL OR REAM THE INTRAMEDULLARY CANAL TO A LARGER DIAMETER. INVESTIGATION CONCLUSION: THE COMPLAINT IS CONFIRMED AS THE INSERTION HANDLE INTERFACE OF THE NAIL IS DEFORMED. DURING THE PERFORMED EVALUATION NO MANUFACTURING RELATED ISSUE COULD BE DETECTED. THE ANODIZED LAYER IS WORN AWAY AT ALL DAMAGES WHICH INDICATES THAT THEY WERE CAUSED POST-MANUFACTURING. THE VISIBLE EXCESSIVE STRESS MARKS INDICATE THAT THE INSERTION HANDLE/NAIL ASSEMBLY WAS EXPOSED TO VERY STRONG ROTATIONAL FORCES IN COMBINATION WITH STRONG HAMMER BLOWS AND THAT FINALLY A MECHANICAL OVERLOAD DID LEAD TO THE DAMAGE OF THE NAIL. IN THIS RELATION THE ABOVE MENTIONED STATEMENTS FROM THE SURGICAL TECHNIQUE CAN BE POINTED OUT TO AVOID SUCH AN OVERLOAD DURING THE NAIL INSERTION. THE ALSO RECEIVED DAMAGED INSERTION HANDLE MAY ALSO HAVE PLAYED A CERTAIN ROLE, BUT AFTERWARDS IT IS IMPOSSIBLE TO DEFINED IF THE DAMAGE AT THE HANDLE DID CONTRIBUTE TO THE DAMAGE OF THE NAIL OR VICE VERSA. BASED ON THE INVESTIGATION FINDINGS, IT HAS BEEN DETERMINED THAT NO CORRECTIVE AND/OR PREVENTATIVE ACTION IS PROPOSED AS NO PRODUCT RELATED ISSUE COULD BE DETECTED. ADDITIONAL MONITORING FOR ANY POTENTIAL SAFETY SIGNALS WILL BE CONDUCTED THROUGH COMPLAINT TRENDING AND OTHER POST MARKET SAFETY SURVEILLANCE ACTIVITIES. DEVICE HISTORY LOT PART: 04.009.560S, LOT: 9662869, MANUFACTURING SITE: MEZZOVICO, RELEASE TO WAREHOUSE DATE: OCT 6, 2015, EXPIRY DATE: SEPT 1, 2025. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE LOT NUMBER, 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 · 1

    REPORTER IS A J&J EMPLOYEE. THE DEVICE WAS RECEIVED, THE INVESTIGATION IS IN PROGRESS, NO CONCLUSION COULD BE DRAWN AT THE TIME OF FILING THIS REPORT. 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

    DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2020, TWO (2) EXPERT A2FN NAILS CRACKED DURING THE PROCEDURE. THE FIRST NAIL CRACKED DURING MALLET PROCEDURE WHILE THE SECOND CRACKED DURING INSERTION. IT WAS REPORTED THAT THE INSERTION HANDLE MAY HAVE CONTRIBUTED TO NAIL FAILURE. THERE WAS A SURGICAL DELAY OF ONE (1) HOUR. THE PROCEDURE WAS COMPLETED WITH A THIRD NAIL. THERE WAS NO PATIENT CONSEQUENCE. CONCOMITANT DEVICE REPORTED: AIMING ARM (PART#: 03.010.382, LOT#: 3654133, QUANTITY: 1); UNKNOWN MALLET (PART#: UNKNOWN, LOT#: UNKNOWN, QUANTITY: 1). THIS REPORT IS FOR ONE (1) EXPERT A2FN NAIL Ø12 R CANN L400 TAN LIG. THIS IS REPORT 2 OF 3 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    960004 EXPERT A2FN NAIL 12 R CANN L400 TAN LIG APPLIANCE, FIXATION, NAIL KTT OBERDORF SYNTHES PRODUKTIONS GMBH 9662869 07611819324411

    Patients

    Seq Age Sex Outcome Treatment
    1 21 YR EXPERT A2FN Ø12 R CANN L400 TAN LIGHT GR| UNK - GUIDES/SLEEVES/AIMING: AIMING ARM| UNK - IMPACTION INSTRUMENTS: HAMMER/MALLET: TRAUMA| UNK - INSERTION INSTRUMENTS: TRAUMA