BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LAG/COM SCREW KIT 110/105

    MDR report key: 13615102 · Received February 27, 2022

    Report

    Report Number
    1020279-2022-00869
    Event Type
    Injury
    Date Received
    February 27, 2022
    Date of Event
    February 7, 2022
    Report Date
    March 24, 2022
    Manufacturer
    SMITH & NEPHEW, INC.
    Product Code
    JDS
    UDI-DI
    03596010563347
    PMA / PMN Number
    K040212
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INTERNAL COMPLAINT REFERENCE: (B)(4).

    Additional Manufacturer Narrative · 0

    THE DEVICE WAS NOT RETURNED FOR EVALUATION AND THE REPORTED EVENT COULD NOT BE CONFIRMED. THE CLINICAL/MEDICAL INVESTIGATION CONCLUDED THAT, SMITH AND NEPHEW HAS NOT RECEIVED THE DEVICE/ADEQUATE CLINICAL DOCUMENTATION TO FULLY EVALUATE THE COMPLAINT. THEREFORE, A THOROUGH MEDICAL INVESTIGATION CANNOT BE RENDERED NOR CAN THE CLINICAL ROOT CAUSE OF THE REPORTED FAILURE BE DETERMINED. THE IMPACT TO THE PATIENT BEYOND THAT WHICH HAS ALREADY BEEN REPORTED CANNOT BE CONFIRMED NOR CONCLUDED. SHOULD ANY ADDITIONAL RELEVANT MEDICAL INFORMATION BE PROVIDED, THIS CASE WOULD BE RE-ASSESSED. A REVIEW OF THE MANUFACTURING RECORDS DID NOT REVEAL A MANUFACTURING ABNORMALITY THAT COULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED INCIDENT. A REVIEW OF COMPLAINT HISTORY FOR THE PART NUMBER OVER THE PAST 12 MONTHS AND FOR THE BATCH NUMBER BASED ON HISTORICAL DATA OF THE DEVICE DID NOT REVEAL SIMILAR EVENTS FOR THE LISTED DEVICE. A REVIEW OF THE INSTRUCTIONS FOR USE DOCUMENTS FOR INTRAMEDULLARY NAIL SYSTEM REVEALED THAT THE RISK OF BREAKAGE OR FAILURE OF THE IMPLANT HAS BEEN IDENTIFIED AS A POSTOPERATIVE CARE. A REVIEW OF THE RISK MANAGEMENT FILE REVEALED THIS FAILURE MODE WAS PREVIOUSLY IDENTIFIED. THE ANTICIPATED RISK LEVEL IS STILL ADEQUATE. A HISTORICAL REVIEW CONCLUDED THAT THERE ARE NO PRIOR ACTIONS RELATED TO THIS PRODUCT AND EVENT. AT THIS TIME, WE HAVE NO REASON TO SUSPECT THAT THE PRODUCT FAILED TO MEET ANY PRODUCT SPECIFICATIONS AT THE TIME OF MANUFACTURE. SOME POTENTIAL PROBABLE CAUSES FOR THIS EVENT COULD INCLUDE BUT NOT LIMITED TO TRAUMATIC INJURY OR SURGICAL TECHNIQUE. THE CONTRIBUTION OF THE DEVICE TO THE REPORTED EVENT COULD NOT BE CORROBORATED. BASED ON THIS INVESTIGATION, THE NEED FOR CORRECTIVE ACTION IS NOT INDICATED. WITHOUT THE RETURN OF THE ACTUAL PRODUCT INVOLVED, OUR INVESTIGATION COULD NOT PROCEED. SHOULD THE DEVICE OR ADDITIONAL INFORMATION BE RECEIVED, THE COMPLAINT WILL BE REOPENED. NO FURTHER INVESTIGATION IS WARRANTED FOR THIS COMPLAINT; HOWEVER, WE WILL CONTINUE TO MONITOR FOR FUTURE COMPLAINTS AND INVESTIGATE AS NECESSARY. WE CONSIDER THIS INVESTIGATION CLOSED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT, AFTER TRAUMA SURGERY WAS PERFORMED ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED A FRACTURE OF THE NECK OF THE FEMUR. THIS ADVERSE EVENT WAS SOLVED WITH A REVISION SURGERY ON (B)(6) 2022, REMOVING THE LAG/COM SCREW KIT 110/105. THE PATIENT'S CURRENT HEALTH STATUS IS UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1303305 LAG/COM SCREW KIT 110/105 NAIL, FIXATION, BONE JDS SMITH & NEPHEW, INC. 71677110 19JT28442 03596010563347

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Hospitalization| R