BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNK - GUIDE/COMPRESSION/K-WIRES

    MDR report key: 15390790 · Received September 9, 2022

    Report

    Report Number
    8030965-2022-06580
    Event Type
    Injury
    Date Received
    September 9, 2022
    Manufacturer
    SYNTHES GMBH
    Product Code
    LRN
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    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. THIS REPORT IS FOR AN UNKNOWN GUIDE/COMPRESSION/K-WIRES/UNKNOWN LOT. PART AND LOT NUMBERS ARE UNKNOWN; UDI NUMBER IS UNKNOWN. COMPLAINANT PART IS NOT EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION. 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 · 0

    THIS REPORT IS BEING FILED AFTER THE REVIEW OF THE FOLLOWING JOURNAL ARTICLE: SETHURAMAN S., ET AL (2022) RADIOGRAPHIC OUTCOMES OF CORTICAL SCREW FIXATION AS AN ALTERNATIVE TO KIRSCHNER WIRE FIXATION FOR TEMPORARY LATERAL COLUMN STABILIZATION IN DISPLACED LISFRANC JOINT FRACTUREDISLOCATIONS: A RETROSPECTIVE COHORT ANALYSIS, BMC MUSCULOSKELETAL DISORDERS VOLUME 23:PAGES 51-54 (USA) THIS RETROSPECTIVE COHORT STUDY AIMS TO EVALUATE THE EFFICACY OF TEMPORARY LATERAL COLUMN CORTICAL SCREW FIXATION AS AN ALTERNATIVE TO K-WIRE FIXATION FOR TMT JOINT FRACTURE-DISLOCATIONS. FROM 2005 TO 2018, 45 CONSECUTIVE PATIENTS WHO UNDERWENT OSSEOUS FIXATION OF LISFRANC JOINT FRACTURE-DISLOCATIONS (MYERSON CLASSIFICATION TYPES A, B1, B2, C1, AND C2 WAS REVIEWED. THIRTY-ONE PATIENTS MET INCLUSION CRITERIA FOR THIS STUDY WITH AGES RANGING FROM EIGHTEEN TO 73 YEARS OLD (MEAN AGE 39.8 ± 15.9 YEARS). FIVE PATIENTS WERE FURTHER EXCLUDED FROM ANALYSIS. TWENTY SIX PATIENTS REMAINED ELIGIBLE FOR ANALYSIS. MEAN AGE FOR THESE PATIENTS WAS 41.0 ± 16.9 YEARS. ALL PATIENTS UNDERWENT MEDIAL AND MIDDLE COLUMN FIXATION WITH 3.5 MM CORTICAL SCREWS (SYNTHES, WEST CHESTER, PA) AND 31 ALSO UNDERWENT LATERAL COLUMN FIXATION EITHER WITH 3.5 MM CORTICAL SCREWS OR 0.062-IN. KIRSCHNER WIRES (SYNTHES, WEST CHESTER, PA). PATIENTS WERE TREATED ACCORDING TO SENIOR AUTHOR PREFERENCE FOR LATERAL COLUMN FIXATION METHOD. 3.5 MM OR 2.7 MM PLATES (SYNTHES, WEST CHESTER, PA) WERE ALSO USED IN MEDIAL COLUMN FIXATION CONSTRUCTS FOR FOURTEEN PATIENTS. THE PRIMARY OUTCOME MEASURE WAS RADIOGRAPHICALLY STABLE LATERAL COLUMN HEALING BEFORE AND AFTER IMPLANT REMOVAL. MEAN FOLLOW-UP WAS 88.2 ± 114 WEEKS FOR ALL PATIENTS. REPORTED COMPLICATIONS: THOSE WITH K-WIRE FIXATION OF THE LATERAL COLUMN WERE MORE LIKELY TO SUFFER FROM DISUSE OSTEOPENIA. TWO PATIENTS IN THE K-WIRE COHORT REQUIRED A CANE FOR AMBULATORY ASSISTANCE DUE TO PERONEAL PALSY AND IPSILATERAL CUBOID AND TALUS FRACTURES, RESPECTIVELY. PATIENTS THAT UNDERWENT LATERAL COLUMN K-WIRE FIXATION WERE MORE LIKELY TO COMPLAIN OF POST-OPERATIVE PAIN. AN ANTEROPOSTERIOR, OBLIQUE, AND LATERAL INJURY RADIOGRAPHS OF THE LEFT FOOT DEMONSTRATING MYERSON TYPE A LATERALLY INCONGRUOUS TMT JOINT FRACTURE-DISLOCATION. B ANTEROPOSTERIOR, OBLIQUE, AND LATERAL POSTOPERATIVE RADIOGRAPHS DEMONSTRATING RESTORATION OF ANATOMIC ALIGNMENT OF MIDFOOT, MEDIAL COLUMN TMT JOINT PRIMARY ARTHRODESIS, AND LATERAL COLUMN K-WIRE FIXATION. C ANTEROPOSTERIOR, OBLIQUE, AND LATERAL POSTOPERATIVE RADIOGRAPHS DEMONSTRATING REMOVAL OF LATERAL COLUMN K-WIRES AND MILD NARROWING OF FOURTH AND FIFTH TMT JOINT. LONGITUDINAL CLINICAL OUTCOMES OF PATIENTS THAT RECEIVED LATERAL COLUMN FIXATION VIA K-WIRE CONSTRUCTS POST-TRAUMATIC ARTHRITIS. DISUSE OSTEOPENIA. AIDED MOBILITY. LONGITUDINAL CLINICAL OUTCOMES OF PATIENTS THAT RECEIVED LATERAL COLUMN FIXATION VIA CORTICAL SCREW. POST-TRAUMATIC ARTHRITIS. DISUSE OSTEOPENIA. AIDED MOBILITY. DID NOT RETURN TO NORMAL SHOE WEAR,ONE PATIENT IN THE CORTICAL SCREW COHORT REQUIRED A ONE-INCH HEEL LIFT POST-OPERATIVELY. LONGITUDINAL RADIOGRAPHIC OUTCOMES OF PATIENTS THAT RECEIVED LATERAL COLUMN FIXATION VIA CORTICAL SCREW: UNSTABLE HARDWARE. NON-HEALING FRACTURE. HARDWARE REMOVED. STAGED HARDWARE REMOVAL. LONGITUDINAL RADIOGRAPHIC OUTCOMES OF PATIENTS THAT RECEIVED LATERAL COLUMN FIXATION VIA K-WIRE CONSTRUCTS: UNSTABLE HARDWARE. HARDWARE REMOVED. STAGED HARDWARE REMOVAL. A COPY OF THE LITERATURE ARTICLE IS BEING SUBMITTED WITH THIS MEDWATCH. THIS REPORT INVOLVES ONE UNK - GUIDE/COMPRESSION/K-WIRES. THIS IS REPORT 3 OF 3 FOR PC- (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1359860 UNK - GUIDE/COMPRESSION/K-WIRES WIRE, SURGICAL LRN SYNTHES GMBH

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention