BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    130 DEG AIMING ARM

    MDR report key: 12413610 · Received September 2, 2021

    Report

    Report Number
    2939274-2021-05118
    Event Type
    Malfunction
    Date Received
    September 2, 2021
    Report Date
    August 3, 2021
    Manufacturer
    WRIGHTS LANE SYNTHES USA PRODUCTS LLC
    Product Code
    HSB
    PMA / PMN Number
    K131548
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    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. IF THE INFORMATION IS UNKNOWN, NOT AVAILABLE OR DOES NOT APPLY, THE SECTION/FIELD OF THE FORM IS LEFT BLANK. B5. D2. D4. D7. D9. G1. G4. H3, H4, H5, H6: ART # 03.037.013-US. LOT # 9910249. MANUFACTURING SITE: (B)(4). RELEASE TO WAREHOUSE DATE: 07 JUL2016. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED ARTICLE LOT AND NO NON-CONFORMANCES WERE IDENTIFIED. VISUAL INSPECTION: THE 130 DEG AIMING ARM (PART #: 03.037.013, LOT #: 9910249) WAS RECEIVED AT US CUSTOMER QUALITY (CQ). VISUAL INSPECTION OF THE COMPLAINT DEVICE SHOWED SURFACE SCRATCHES. ALSO THE LOCKING DEVICE FOR TFNA AIMING ARM WAS NOT RETURNED. FUNCTIONAL TEST: A FUNCTIONAL ASSESSMENT WAS PERFORMED BY ASSEMBLING THE DEVICE WITH MATING CONCOMITANT DEVICE (PART # 03.037.012; LOT# 9880054). BOTH ASSEMBLED CORRECTLY. ALSO RETURNED COMPONENTS (PART # 03.025.040 LOT# 9875043; PART # 03.010.065 LOT# L000467AND PART # 03.010.070, LOT# 9894041) WERE ASSEMBLED TOGETHER AND INSERTED INTO THE ASSEMBLED AIMING ARM AND INSERTION HANDLE. NO ISSUE WAS IDENTIFIED AND ALL DEVICES ASSEMBLED CORRECTLY WITH NO ISSUE. CAN THE COMPLAINT BE REPLICATED WITH THE RETURNED DEVICE? NO. DIMENSIONAL INSPECTION: NO DIMENSIONAL INSPECTION WAS PERFORMED AS THERE WAS NO DAMAGE THAT WARRANTED A DIMENSIONAL INSPECTION. DOCUMENT/SPECIFICATION REVIEW: CURRENT AND MANUFACTURED WERE REVIEWED. NO DESIGN ISSUES OR DISCREPANCIES WERE IDENTIFIED. COMPLAINT CONFIRMED? NO. INVESTIGATION CONCLUSION: THIS COMPLAINT IS NOT CONFIRMED AS THERE WAS NO DEFECT OBSERVED ON THE COMPLAINT DEVICE THAT COULD CONTRIBUTE TO THE REPORTED ALLEGATION. ALSO FUNCTIONAL ASSESSMENT PERFORMED SHOWED NO DEFECT. HOWEVER SURFACE SCRATCHES WERE NOTICED. NO ROOT CAUSE COULD DEFINITIVELY BE DETERMINED FOR THE REPORTED COMPLAINT CONDITION. NO NEW, UNIQUE OR DIFFERENT PATIENT HARMS WERE IDENTIFIED AS A RESULT OF THIS EVALUATION. THERE WAS NO INDICATION THAT A DESIGN OR MANUFACTURING ISSUE CONTRIBUTED TO THE COMPLAINT. NO DESIGN ISSUES WERE OBSERVED DURING THE DOCUMENT/SPECIFICATION REVIEW. BASED ON THE INVESTIGATION FINDINGS, IT HAS BEEN DETERMINED THAT NO CORRECTIVE AND/OR PREVENTIVE ACTION IS PROPOSED. ADDITIONAL MONITORING FOR ANY POTENTIAL SAFETY SIGNALS WILL BE CONDUCTED THROUGH COMPLAINT TRENDING AND OTHER POST MARKET SAFETY SURVEILLANCE ACTIVITIES. 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

    CONCOMITANT DEVICES: CONNECTING SCREW ( PART # 03.037.010, LOT #: 9872034, QUANTITY: 1).INSERTION HANDLE ( PART # 03.037.012, LOT #: 9880054, QUANTITY: 1).DRILL SLEEVE (PART # 03.010.065, LOT #: L000467, QUANTITY: 1).PROTECTION SLEEVE (PART #03.025.040, LOT #: 9875043, QUANTITY: 1).

    Additional Manufacturer Narrative · 1

    ADDITIONAL NARRATIVE: 510K: THIS REPORT IS FOR AN UNKNOWN GUIDES/SLEEVES/AIMING: AIMING ARM/UNKNOWN LOT. PART AND LOT NUMBERS ARE UNKNOWN; UDI NUMBER IS UNKNOWN. COMPLAINANT PART IS EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION, BUT HAS YET TO BE RECEIVED. REPORTER IS A J&J EMPLOYEE. WITHOUT A LOT NUMBER THE DEVICE HISTORY RECORDS REVIEW COULD NOT BE COMPLETED. PRODUCT WAS NOT RETURNED. BASED ON THE INFORMATION AVAILABLE, IT HAS BEEN DETERMINED THAT NO CORRECTIVE AND/OR PREVENTATIVE ACTION IS PROPOSED. THIS COMPLAINT WILL BE ACCOUNTED FOR AND MONITORED VIA POST MARKET SURVEILLANCE ACTIVITIES. IF ADDITIONAL INFORMATION IS MADE AVAILABLE, THE INVESTIGATION WILL BE UPDATED AS APPLICABLE. 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 ON AN UNKNOWN DATE DURING A TIBIA PROCEDURE, THE SURGEON WAS EXPERIENCING DIFFICULTY PUTTING A SCREW ON THE TROCHANTERIC FIXATION NAIL ADVANCED (TFNA) NAIL. IT WAS NOTED THAT THE UNKNOWN AIMING ARM WAS LOOSE. IT IS UNKNOWN IF THERE WAS A SURGICAL DELAY. THE PROCEDURE AND PATIENT OUTCOME ARE UNKNOWN. THERE IS NO FURTHER INFORMATION AVAILABLE. THIS REPORT IS FOR ONE (1) UNK - GUIDES/SLEEVES/AIMING: AIMING ARM. THIS IS REPORT 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1313835 130 DEG AIMING ARM ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES HSB WRIGHTS LANE SYNTHES USA PRODUCTS LLC 9910249

    Patients

    Seq Age Sex Outcome Treatment
    1 11.0/8.0 PROTECTION SLEEVE 188 FOR ASLS| 4.2MM TROCAR 210MM| 8.0MM/4.2MM DRILL SLEEVE 200MM| CANNULATED CONNECTING SCREW| COMPLETE RADIOLUCENT INSERTION HANDLE| UNKNOWN SCREWS| UNKNOWN SCREWS