BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNK - ELASTIC NAILS

    MDR report key: 11689434 · Received April 19, 2021

    Report

    Report Number
    8030965-2021-03047
    Event Type
    Injury
    Date Received
    April 19, 2021
    Report Date
    March 30, 2021
    Manufacturer
    SYNTHES GMBH
    Product Code
    HSB
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT IS FOR AN UNKNOWN ELASTIC NAILS/UNKNOWN LOT. PART AND LOT NUMBER ARE UNKNOWN. WITHOUT THE SPECIFIC PART NUMBER; THE UDI NUMBER AND 510-K NUMBER IS UNKNOWN. COMPLAINANT PART IS NOT EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION. WITHOUT A LOT NUMBER THE DEVICE HISTORY RECORDS REVIEW COULD NOT BE COMPLETED. PRODUCT WAS NOT RETURNED. 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 · 1

    THIS REPORT IS BEING FILED AFTER THE REVIEW OF THE FOLLOWING JOURNAL ARTICLE: THOMPSON, N. ET AL (2010), THE USE OF MINIMALLY INVASIVE TECHNIQUES IN MULTI-LEVEL SURGERY FOR CHILDREN WITH CEREBRAL PALSY: PRELIMINARY RESULTS, THE JOURNAL OF BONE AND JOINT SURGERY. BRITISH VOLUME, VOL. 92-B (10), PAGES 1442-1448, HTTPS://DOI.ORG/10.1302/0301-620X.92B10.24307 ((B)(6)). THE AIM OF THIS PROSPECTIVE COHORT STUDY IS TO DESCRIBE THE PRELIMINARY RESULTS OF A PILOT STUDY COMPARING THE OUTCOMES OF MINIMALLY INVASIVE SINGLE-EVENT MULTI-LEVEL SURGERY WITH CONVENTIONAL MULTILEVEL PROCEDURES. A TOTAL OF 10 PATIENTS WITH A MEAN AGE OF 10.6 YEARS (7.11 TO 13.9) HAD MINIMALLY INVASIVE SURGERY ON 18 LIMBS. THESE PATIENTS WERE MATCHED FOR AMBULATORY LEVEL AND COMPARED WITH 10 PATIENTS WITH A MEAN AGE OF 11.4 YEARS (7.9 TO 14.4) WHO UNDERWENT CONVENTIONAL MULTI-LEVEL SURGERY ON 20 LIMBS. IN 10 PATIENTS, CALCANEAL OSTEOTOMIES WERE FIXED WITH A SMALL FRAGMENT AO PLATE (SYNTHES INC.(B)(4)) TO ACHIEVE IMMEDIATE STABILITY. AN INNOVATIVE TECHNIQUE WAS USED FOR DEROTATION OSTEOTOMY OF THE FEMUR AND TIBIA, BASED ON CLOSED CORTICOTOMY AND FIXATION WITH THE TITANIUM ELASTIC NAILS (SYNTHES INC.). FEMORAL DEROTATION OSTEOTOMY WAS PERFORMED IN ALL CASES WHILE TIBIAL DEROTATION OSTEOTOMY IN 1 CASE (TABLE 1). THE MEAN FOLLOW-UP PERIOD WAS UNKNOWN. THE FOLLOWING COMPLICATIONS WERE REPORTED AS FOLLOWS: MINIMALLY INVASIVE GROUP: PATIENT 2: A (B)(6) MALE PATIENT DEVELOPED A TRANSIENT LEFT TROCHANTERIC BURSITIS. PATIENT 3: A (B)(6) MALE PATIENT DEVELOPED TRANSIENT NEUROPATHIC PAIN IN THE RIGHT FOOT. IN AN UNKNOWN NUMBER OF PATIENTS, THERE WAS A SIGNIFICANT REDUCTION OF KNEE FLEXOR STRENGTH (P < 0.001) AT 12 MONTHS COMPARED WITH PRE-OPERATIVELY, BUT IMPROVED STRENGTH IN THE HIP ABDUCTORS AND KNEE EXTENSORS AT 90¿ AND 30¿. CONVENTIONAL GROUP: PATIENT 20: A (B)(6) FEMALE PATIENT HAD FAILURE OF FIXATION REQUIRING REVISION WHEN SHE FELL AT HOME FIVE WEEKS POSTOPERATIVELY. IN AN UNKNOWN NUMBER OF PATIENTS, MUSCLE STRENGTH WAS REDUCED AT 12 MONTHS COMPARED WITH PRE-OPERATIVELY IN ALL LOWER-LIMB MUSCLE GROUPS, EXCEPT FOR THE HIP ABDUCTORS (FIG. 2). THIS REPORT IS FOR AN UNKNOWN SYNTHES ELASTIC NAILS. IT CAPTURES REPORTED EVENT OF SIGNIFICANT REDUCTION OF KNEE FLEXOR STRENGTH IN MINIMALLY INVASIVE GROUP AND MUSCLE STRENGTH WAS REDUCED IN THE CONVENTIONAL GROUP. A COPY OF THE LITERATURE ARTICLE IS BEING SUBMITTED WITH THIS MEDWATCH. THIS IS REPORT 1 OF 7 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    582273 UNK - ELASTIC NAILS ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES HSB SYNTHES GMBH

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention