BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ZNN¿¢, CMN LAG SCREW, ø 10.5 MM, 115 MM INCLUDING SET SCREW

    MDR report key: 16774595 · Received April 20, 2023

    Report

    Report Number
    0009613350-2023-00143
    Event Type
    Injury
    Date Received
    April 20, 2023
    Date of Event
    February 17, 2023
    Report Date
    August 10, 2023
    Manufacturer
    ZIMMER SWITZERLAND MANUFACTURING GMBH
    Product Code
    HSB
    UDI-DI
    00889024298484
    PMA / PMN Number
    K091566
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). CONCOMITANT MEDICAL PRODUCTS:¿ CMN FEMORAL NAIL, CCD 125, RIGHT, 11.5 MM, 21.5 CM ITEM# 47249321011, LOT# 3143338, 5.0 MM DIAMETER CORTICAL SCREW - RED FIXED ANGLE 3.5 MM HEX HEAD, ITEM# 47248403250, LOT# 65613735, 5.0 MM DIAMETER CORTICAL SCREW - RED FIXED ANGLE 3.5 MM HEX HEAD, ITEM# 47248404550 LOT# 65378233. FOREIGN ¿¿FRANCE". MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE THE ASSOCIATED REPORTS: 0009613350-2023-00141. INVESTIGATION OF THIS INCIDENT IS CURRENTLY ONGOING. ONCE THE INVESTIGATION IS COMPLETED, A SUPPLEMENTAL MEDWATCH 3500A WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL AND/OR CORRECTED INFORMATION. NO PRODUCT WAS RETURNED OR PICTURES PROVIDED; VISUAL AND DIMENSIONAL EVALUATIONS COULD NOT BE PERFORMED. MEDICAL DOCUMENTS IN THE FORM OF SURGICAL REPORT AND IMPLANT LABELS WERE PROVIDED AND REVIEWED BY HCP: FINDINGS: GENERAL ANESTHESIA. SUB-TROCHANTERIC APPROACH. PLACEMENT OF THE CEPHALIC PIN IN THE CENTER OF THE HEAD, IN THE CENTER OF THE NECK. MEASUREMENT AT THE 115M BOREHOLE LENGTH. INSERTION OF A CERVICAL SCREW LENGTH 115 AND TWO. DISTAL SCREWS USING THE AUTOMATIC ANCILLARY, THE CEPHALIC SENSATION, THE NAIL AND ITS GUIDE GOES UP OUTSIDE THE PATIENT, THE CEPHALIC SCREW HAVING PASSED IN FRONT OF THE NAIL AND NOT INSIDE OF IT. C-ARM CHECK FOR PLACEMENT OF NAIL AND SCREWS, THE CERVICAL SCREW AND THE 2 DISTAL SCREWS HAD BEEN PASSED OVER THE NAIL, AND NOT THROUGH THE HOLES PROVIDED FOR THIS PURPOSE ALL COMPONENTS EXCHANGED. THE SURGEON ASKED THAT THIS MALFUNCTIONING C-ARM BE ASSESSED AND THE ARCH BE APPRAISED (ON LATER CLARIFICATION, IT WAS DISCOVERED THAT THE SURGEON WAS REFERRING TO THE TARGETING GUIDE AND NOT TO THE C-ARM FLUOROSCOPY SYSTEM) SIGNIFICANT INCREASE IN SURGICAL TIME. BASED ON THE GIVEN INFORMATION AND RESULTS OF THE INVESTIGATION, A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED. IF ANY FURTHER INFORMATION IS FOUND WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL REPORT WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS

    Additional Manufacturer Narrative · 0

    UPON REVIEW OF THIS COMPLAINT FROM AN INVESTIGATION PERSPECTIVE, IT IS NOW CONFIRMED THAT THE EVENT IS CONSIDERED AS MISASSEMBLY BY USERS HENCE THIS EVENT WILL BE NON -REPORTABLE AND REPORT WILL BE VOIDED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A PATIENT UNDERWENT A PROCEDURE FOR A PERTROCHANTERIC FRACTURE WITH A NAIL. POST-OP X-RAYS SHOWED THE CERVICAL SCREW AND THE TWO DISTAL SCREWS HAD PASSED ABOVE THE NAIL, AND NOT PASSED THROUGH THE HOLES PROVIDED IN THE NAIL. THE NAIL WAS REMOVED AND REPLACED. DUE DILIGENCE IS IN PROGRESS FOR THIS COMPLAINT; TO DATE NO ADDITIONAL INFORMATION OR PRODUCT HAS BEEN RECEIVED.

    Description of Event or Problem · 0

    NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT: AN INTRA-OP ASSEMBLY ISSUE OCCURRED DURING THE OP. THE CERVICAL SCREW AND THE 2 DISTAL SCREWS HAD PASSED ABOVE THE NAIL AND NOT IN THE HOLES PROVIDED FOR THIS PURPOSE. THE NAIL WAS REMOVED THEN REPLACED WITH ANOTHER ZIMMER NAIL WITH ANOTHER ANCILLARY. THE EVENT WAS EVALUATED AS NON-REPORTABLE DURING THE INVESTIGATION. IF ANY FURTHER INFORMATION IS FOUND WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL REPORT WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1156445 ZNN¿¢, CMN LAG SCREW, ø 10.5 MM, 115 MM INCLUDING SET SCREW ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES HSB ZIMMER SWITZERLAND MANUFACTURING GMBH N/A 3093322 00889024298484

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR Male Hospitalization| R