BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN ORTHOCORD

    MDR report key: 9186160 · Received October 14, 2019

    Report

    Report Number
    1221934-2019-58927
    Event Type
    Injury
    Date Received
    October 14, 2019
    Report Date
    October 9, 2019
    Manufacturer
    DEPUY MITEK LLC US
    Product Code
    MAI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT IS FOR AN UNKNOWN. 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. CONCOMITANT MEDICAL PRODUCTS: UNKNOWN. 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: BASSEM T. ELHASSAN ET AL, 2016, ¿CONTRALATERAL TRAPEZIUS TRANSFER TO RESTORE SHOULDER EXTERNAL ROTATION FOLLOWING ADULT BRACHIAL PLEXUS INJURY¿, JOURNAL OF SHOULDER AND ELBOW SURGERY VOLUME 41 NUMBER 4 PAGES E45-E51, USA. TO EVALUATE THE OUTCOME OF CONTRALATERAL LOWER TRAPEZIUS ORIGIN TRANSFER (CLTOT) TO RESTORE SHOULDER EXTERNAL ROTATION IN PATIENTS WITH SHOULDER PARALYSIS AFTER BRACHIAL PLEXUS INJURY (BPI). THE PATIENTS EVALUATED ON COURSE OF THIS STUDY: WE EVALUATED 12 PATIENTS WITH A HISTORY OF BPI WITH PERSISTENT SHOULDER PARALYSIS. 10 MEN AND 2 WOMEN, AVERAGE AGE OF 35 YEARS (RANGE, 19¿59 YEARS). YEARS). AVERAGE TIME BETWEEN NERVE SURGERY AND CLTOT WAS 18 MONTHS (RANGE, 15¿43 MONTHS). WE RECOMMENDED CLTOT IF BY 15 MONTHS FROM THE TIME OF NERVE SURGERY OR INJURY THE PATIENT HAD NO SIGN OF NERVE RECOVERY BY ELECTROMYOGRAM AND HAD AT LEAST ANTIGRAVITY ELBOW FLEXION. ALL PATIENTS UNDERWENT BRACHIAL PLEXUS RECONSTRUCTION AT AN AVERAGE OF 4 MONTHS AFTER INJURY. ALL PATIENTS HAD VARIABLE DEGREES OF RESTORED ELBOW FLEXION, WITH AT LEAST M3 MUSCLE STRENGTH. NO PATIENTS REGAINED SHOULDER ER. NO PATIENT UNDERWENT PRIOR SHOULDER TENDON TRANSFER. DURING ACTIVE ELBOW FLEXION, OWING TO THE LACK OF SHOULDER ER, ALL PATIENTS WERE BLOCKED BY THEIR ABDOMENS OR CHESTS FROM REACHING THEIR MOUTHS. OUR MEASUREMENT OF ER WAS 0° ER WHEN THE HAND WAS ON THE ABDOMEN. THUS, IN PATIENTS WHO COULD NOT INITIATE ER TO MOVE THE HAND AWAY FROM THE ABDOMEN, ER WAS MEASURED AS 0°. IN ADDITION, 5 PATIENTS HAD GROSS AND PAINFUL INFERIOR SUBLUXATION OF THE SHOULDER WITH A POSITIVE SULCUS SIGN. FOUR OF THESE PATIENTS HAD A HISTORY OF MULTIPLE TENDON TRANSFERS, INCLUDING ONE WHO HAD ISOLATED CLTOT. THE ARTICLE DESCRIBES THE FOLLOWING PROCEDURE: ALL PATIENTS ARE POSITIONED IN THE PRONE POSITION DURING THE TRANSFER. THE CLTOT PROLONGED WITH LUMBOSACRAL FASCIA IS HARVESTED THROUGH A CAUDAD SMALL INCISION AT THE LEVEL OF TIO. THEN A SMALL CEPHALAD INCISION IS PERFORMED AT THE LEVEL OF T4, AND AFTER CREATING A WIDE TUNNEL BETWEEN THE 2 INCISIONS, THE LOWER TRAPEZIUS ORIGIN IS DETACHED FROM CAUDAD TO CEPHALAD TO THE LEVEL OF T4 AND RETRIEVED FROM THE CAUDAD TO THE CEPHALAD INCISION USING A GRASPING CLAMP. A DEEP, WIDE TUNNEL IS CREATED BETWEEN THE CONTRALATERAL PROXIMAL PARASPINAL WOUND AND THE SHOULDER WOUND TO ALLOW RETRIEVAL OF THE HARVESTED TRAPEZIUS INTO THE IPSILATERAL SHOULDER WOUND. THE SHOULDER IS PLACED IN MAXIMAL EXTERNAL ROTATION AND THE PROLONGED TENDINOUS PORTION OF THE LOWER TRAPEZIUS ORIGIN IS SUTURED TO THE INFRASPINATUS TENDON USING SUTURES AND MULTIPLE INTERRUPTED NUMBER 2 ORTHOCORD SUTURE (DEPUY, WARSAW, IN). THE DELTOID IS THEN REPAIRED USING TRANSOSSEOUS SUTURES TO THE SPINE OF THE SCAPULA. DEEP SUCTION DRAINS ARE LEFT IN THE WOUNDS, AND THE WOUNDS ARE CLOSED IN LAYERS. PATIENTS ARE USUALLY ABLE TO ACTIVATE THE TRANSFER BY 8 TO 10 WEEKS AFTER SURGERY AND SLOWLY GAIN STRENGTH AND IMPROVED CONTROL OVER 3 TO 6 MONTHS. BY 6 MONTHS, PATIENTS ARE GENERALLY ABLE TO USE THE TRANSFER SPONTANEOUSLY. WE COMPARED DIFFERENCES BETWEEN PREOPERATIVE AND POSTOPERATIVE GROUPS USING THE 2-SAMPLE T TEST FOR CONTINUOUS VARIABLES AND CHI SQUARE TEST (OR FISHER EXACT TEST) FOR CATEGORICAL VARIABLES. P < .05 WAS CONSIDERED STATISTICALLY SIGNIFICANT. THE DEVICES INVOLVED WERE: NUMBER 2 ORTHOCORD SUTURE (DEPUY, WARSAW, IN). COMPLICATIONS MENTIONED IN THE CASE REPORT WERE: ONE PATIENT SUSTAINED A FALL RESULTING IN STRETCH INJURY TO THE TRANSFER, UNDERWENT SUCCESSFUL REVISION SURGERY, AND REGAINED 100° ACTIVE SHOULDER EXTERNAL ROTATION AWAY FROM THE ABDOMEN MORE THAN A YEAR AFTER REVISION SURGERY. ANOTHER PATIENT'S TRANSFER FAILED DURING REHABILITATION, BUT THE PATIENT ELECTED NOT TO PURSUE TREATMENT. NO PATIENTS HAD CHANGES IN CONTRALATERAL SHOULDER MOTION OR STRENGTH OR ANY PAIN FROM THE CONTRALATERAL SHOULDER. THIS STUDY DEMONSTRATED THAT CLTOT TO THE INFRASPINATUS TENDON WAS EFFECTIVE IN IMPROVING SHOULDER EXTERNAL ROTATION IN PATIENTS WITH BPI.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    981832 UNKNOWN ORTHOCORD SOFT-TISSUE ANCHOR, BIOABSORBABLE MAI DEPUY MITEK LLC US

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention