BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNK - SCREWS: 7.0 MM CANNULATED

    MDR report key: 18234096 · Received November 29, 2023

    Report

    Report Number
    8030965-2023-15020
    Event Type
    Injury
    Date Received
    November 29, 2023
    Manufacturer
    SYNTHES GMBH
    Product Code
    HWC
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TW
    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. D1, D2, D3, D4, G4-510K: THIS REPORT IS FOR AN UNKNOWN LOCKING SCREWS/UNKNOWN LOT. PART AND LOT NUMBER ARE UNKNOWN. WITHOUT THE SPECIFIC PART NUMBER; THE UDI NUMBER AND 510-K NUMBER IS UNKNOWN. D9: COMPLAINANT PART IS NOT EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION. H3, H4, H6: WITHOUT A LOT NUMBER THE DEVICE HISTORY RECORDS REVIEW COULD NOT BE COMPLETED. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. 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 · 0

    THIS REPORT IS BEING FILED AFTER THE REVIEW OF THE FOLLOWING JOURNAL ARTICLE: HSU, C.H. ET AL (2022), DISTAL FEMUR GROWTH MODIFICATION SURGERY IS ASSOCIATED WITH HIGHER SURGICAL WOUND COMPLICATION RATE, J PEDIATR ORTHOP, VOL. 42 (8), PAGES 451-455, SEPTEMBER 2022, (TAIWAN) THIS STUDY AIMED TO REPORT THE RATE, SEVERITY, AND POSSIBLE RISK FACTORS FOR SURGICAL WOUND COMPLICATION AFTER GROWTH MODIFICATION SURGERIES. THIS IS A RETROSPECTIVE STUDY BETWEEN JANUARY 2007 AND DECEMBER 2019 REVIEWED SURGICAL WOUND COMPLICATIONS IN 622 PEDIATRIC ORTHOPEDIC PATIENTS IN WHICH DIVIDED INTO A GROWTH MODIFICATION GROUP (N =418) 195 MALE AND 213 FEMALE WITH THE MEAN AGE 10.0 ± 3.2. IN OSTEOTOMY GROUP (N = 204) 109 MALE AND 95 FEMALES WITH THE MEAN AGE OF 12.0 ± 7.1. THE MEAN OPERATION TIME IN THE GROWTH MODIFICATION GROUP WAS SIGNIFICANTLY SHORTER THAN THAT IN THE OSTEOTOMY GROUP (99 VS. 209 MIN, P <0.01). IN GROWTH MODIFICATION GROUP, A STAINLESS-STEEL PLATE (SYNTHES, JOHNSON & JOHNSON) AND 7.0-MM CANNULATED SCREWS (AO, SYNTHES, INC., CHESTER, PA, USA) AT 205 SITES, RESPECTIVELY. THE OTHER IMPLANTS INCLUDED WERE TITANIUM STAPLES (SMITH-NEPHEW, MEMPHIS, TN,USA) AT 19 SITES 8 PLATES (ORTHOFIX SRL, VERONA, ITALY) AT 184 SITES, HINGE PLATES (PEGA MEDICAL, LAVAL, QUEBEC, CANADA) AT 47 SITES. ON THE OTHER HAND, IN OSTEOTOMY GROUP, THE IMPLANTS INCLUDED AN ANGLED PLATE (AO, SYNTHES, INC., CHESTER, PA, USA) AT 269 SITES, A DYNAMIC COMPRESSION PLATE (AO, SYNTHES, INC) AT 34 SITES AND AN LCP PEDIATRIC HIP PLATE (DEPUY SYNTHES, RAYNHAM, MA, USA) AT 24 SITES AND AND KIRSCHNER WIRES (K-WIRES) AT 4 SITES. THE FOLLOWING COMPLICATIONS WERE REPORTED AS FOLLOWS: IN GROWTH MODIFICATION GROUP: (N=15) WOUND RELATED INFECTION FOR THE STEEL PLATE. (N=1) WOUND RELATED INFECTION FOR THE CANNULATED SCREW. AMONG THE MENTIONED COMPLICATIONS IN THE GROUP, THEY ALSO EXPERIENCED GRADE III IN THE CLAVIEN-DINDO COMPLICATION CLASSIFICATION SYSTEM WHICH IS TREATABLE INFECTION THAT REQUIRED SURGICAL DEBRIDEMENT OR UNPLANNED HOSPITAL READMISSION AND GRADE II IN THE CLAVIEN-DINDO COMPLICATION CLASSIFICATION SYSTEM REQUIRING SURGICAL DEBRIDEMENT AND 5 REQUIRING UNPLANNED HOSPITAL READMISSIONS FOR PARENTERAL ANTIBIOTICS. IN OSTEOTOMY GROUP: (N=?) WOUND INFECTION CAUSED BY UNDETERMINED IMPLANT (SYNTHES/NON SYNTHES DEVICE) CONTRIBUTED THE COMPLICATION OWING TO UNPLANNED HOSPITAL READMISSION. THIS REPORT IS FOR AN UNKNOWN SYNTHES 7.0-MM CANNULATED SCREWS. A COPY OF THE LITERATURE ARTICLE IS BEING SUBMITTED WITH THIS MEDWATCH. THIS IS REPORT 2 OF 2 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1846141 UNK - SCREWS: 7.0 MM CANNULATED SCREW, FIXATION, BONE HWC SYNTHES GMBH

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention