BEUDAMED
    FDA Adverse Event Injury Summary report: N

    11.0MM TI TROCH FIXATION NAIL SCREW/120MM - STERILE

    MDR report key: 8551762 · Received April 25, 2019

    Report

    Report Number
    2939274-2019-57664
    Event Type
    Injury
    Date Received
    April 25, 2019
    Report Date
    March 27, 2019
    Manufacturer
    WRIGHTS LANE SYNTHES USA PRODUCTS LLC
    Product Code
    HSB
    UDI-DI
    10886982094896
    PMA / PMN Number
    K092646
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    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. A DEVICE HISTORY RECORD (DHR) REVIEW WAS CONDUCTED: MANUFACTURING LOCATION: MONUMENT, MANUFACTURING DATE: 28-JUN-2010, EXPIRATION DATE: 31-MAY-2020, PART NUMBER: 04.032.120S, 11.0MM TI TROCH FIXATION NAIL SCREW/120MM ¿ STERILE, LOT NUMBER: 6415533 (STERILE), LOT QUANTITY: 12 . WORK ORDER TRAVELER MET ALL INSPECTION ACCEPTANCE CRITERIA. THIS LOT MET ALL DIMENSIONAL, VISUAL, STERILITY AND PACKAGING CRITERIA AT THE TIME OF RELEASE WITH NO ISSUES DOCUMENTED DURING THE MANUFACTURE THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. COMPONENT PART(S) REVIEWED: PART NUMBER: 21012, TIALNBRI13.00, LOT NUMBER: 6030780, LOT QUANTITY: 1,565 LBS. PRODUCT TRAVELER MET ALL INSPECTION ACCEPTANCE CRITERIA. THIS LOT MET ALL DIMENSIONAL, VISUAL, STERILITY AND PACKAGING CRITERIA AT THE TIME OF RELEASE WITH NO ISSUES DOCUMENTED DURING THE MANUFACTURE THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. 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

    ADDITIONAL DEVICE PROCODE: HWC. DEVICE IS NOT EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION. (B)(4). PRODUCT WAS NOT RETURNED. BASED ON THE INFORMATION AVAILABLE, IT HAS BEEN DETERMINED THAT NO CORRECTIVE AND 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 (B)(6) 2019, THE PATIENT UNDERWENT ORTHOPEDIC PROCEDURE. DURING THE PROCEDURE, ONE (1) TITANIUM CANNULATED TROCHANTERIC FIXATIONAL NAIL, ONE (1) TITANIUM CANNULATED TROCHANTERIC FIXATION NAIL SCREW, ONE (1) TITANIUM LOCKING SCREW 42MM FOR INTRAMEDULLARY NAILS AND ONE (1) TITANIUM LOCKING SCREW 48MM FOR INTRAMEDULLARY NAILS WERE REMOVED. THE TITANIUM CANNULATED TROCHANTERIC FIXATION NAIL SCREW ADVANCED AND CUT OUT OF THE FEMORAL HEAD WAS PAINFUL TO THE PATIENT AND A HARDWARE MALFUNCTION. THE NAIL WAS REMOVED WITH NO ISSUES. PROCEDURE WAS CONVERTED TO A TOTAL HIP ARTHROPLASTY ON THIS PATIENT. IT IS UNKNOWN IF THERE WAS SURGICAL DELAY. PROCEDURE OUTCOME IS UNKNOWN WITH NO PATIENT CONSEQUENCE. CONCOMITANT DEVICE REPORTED: TITANIUM LOCKING SCREW 42MM FOR INTRAMEDULLARY NAILS (PART 458.942, LOT UNKNOWN, QUANTITY 1), TITANIUM LOCKING SCREW 48MM FOR INTRAMEDULLARY NAILS (PART 458.948, LOT UNKNOWN, QUANTITY 1). THIS REPORT IS FOR ONE (1) TITANIUM CANNULATED TROCHANTERIC FIXATION NAIL SCREW. THIS IS REPORT 2 OF 2 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    346273 11.0MM TI TROCH FIXATION NAIL SCREW/120MM - STERILE ROD,FIXATION,INTRAMEDULLARY HSB WRIGHTS LANE SYNTHES USA PRODUCTS LLC 04.032.120S 6415533 10886982094896

    Patients

    Seq Age Sex Outcome Treatment
    1 85 YR Required Intervention