BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PLATE,FIXATION,BONE

    MDR report key: 7429068 · Received April 13, 2018

    Report

    Report Number
    2939274-2018-51658
    Event Type
    Injury
    Date Received
    April 13, 2018
    Report Date
    March 26, 2018
    Manufacturer
    WRIGHTS LANE SYNTHES USA PRODUCTS LLC
    Product Code
    HRS
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    PATIENT INFORMATION IS UNKNOWN. RANCY, S. K., EK, E. T., PAUL, S., HOTCHKISS, R. N., AND WOLFE, S. W. (2017). NON-SPANNING TOTAL WRIST ARTHRODESIS WITH A LOW-PROFILE LOCKING PLATE. JOURNAL OF WRIST SURGERY. USA. ARTICLE WAS ACCEPTED AFTER REVISION ON JULY 24, 2017. THIS REPORT IS FOR UNKNOWN QUANTITY OF UNKNOWN PLATE /UNKNOWN LOT. PART AND LOT NUMBER ARE UNKNOWN; UDI 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. THE MANUFACTURE DATE IS UNKNOWN. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. (B)(4). 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. (B)(4)

    Description of Event or Problem · 1

    THIS REPORT IS BEING FILED AFTER THE REVIEW OF THE FOLLOWING JOURNAL ARTICLE: RANCY, S. K., EK, E. T., PAUL, S., HOTCHKISS, R. N., AND WOLFE, S. W. (2017). NON-SPANNING TOTAL WRIST ARTHRODESIS WITH A LOW-PROFILE LOCKING PLATE. JOURNAL OF WRIST SURGERY. USA. THE STUDY WAS A RETROSPECTIVE REVIEW OF MEDICAL CHARTS WITH THE GOAL OF COMPARING OUTCOMES BETWEEN FIFTEEN (15) FRACTURES [FIFTEEN (15) PATIENTS] TREATED WITH THE NON-SPANNING WRIST FUSION TECHNIQUE USING A 2.7/3.5 MM LOCKING T-PLATE TO TWELVE (12) FRACTURES [ELEVEN (11) PATIENTS] TREATED WITH THE SPANNING WRIST FUSION TECHNIQUE USING A 2.7/3.5 MM LOCKING COMPRESSION PLATE. ONLY PATIENTS WITH A MINIMUM OF THREE (3) MONTHS OF FOLLOW-UPS WERE INCLUDED IN THE STUDY. THE FIFTEEN (15) NON-SPANNING ARTHRODESIS WERE PERFORMED BETWEEN JANUARY 2011 AND MARCH 2016, WHEREAS THE TWELVE (12) SPANNING TOTAL WRIST ARTHRODESIS WERE PERFORMED BETWEEN MARCH 2002 AND JULY 2011. THE PRIMARY OUTCOME OF COMPARISON WAS FUSION, AND THE SECONDARY OUTCOMES INCLUDED TIME TO UNION IN WEEKS, NUMERICAL RATING SCALE (NRS) PAIN SCORE FROM 1 TO 10, PATIENT-RATED WRIST EVALUATION (PRWE) SCORE, GRIP STRENGTH AND COMPLICATIONS LIKE NEUROPATHY, TENDINOPATHY, HARDWARE REMOVAL, HARDWARE LOOSENING OR BREAKAGE AND PERI-IMPLANT FRACTURE. THE CONSTRUCT IMPLANTED WITHIN FRACTURES TREATED WITH THE SPANNING ARTHRODESIS TECHNIQUE INCLUDED ONE (1) 9-HOLE 2.7/3.5 MM LOCKING COMPRESSION PLATE (SYNTHES, (B)(4)), THREE (3) SELF-TAPPING 2.7 MM SCREWS, THREE (3) 3.5 MM CORTICAL SCREWS, AND ONE (1) UNKNOWN SCREW; FINALLY, THE CONSTRUCT WAS CLOSED INTO THE PATIENT WITH NON-ABSORBABLE SUTURES. THE CONSTRUCT IMPLANTED WITHIN FRACTURES WITH THE NON-SPANNING ARTHRODESIS TECHNIQUE INCLUDED ONE (1) 2.4/2.7 MM VOLAR DISTAL RADIUS LOCKING COMPRESSION PLATE (SYNTHES), MULTIPLE (UNKNOWN QUANTITY) OF FIXED ANGLES 2.4 MM LOCKING SCREWS AND UNKNOWN QUANTITY OF UNKNOWN LOCKING AND UNKNOWN NON-LOCKING SCREWS. THE FOLLOWING COMPLICATIONS WERE OBSERVED BASED ON THE RESULTS OF THIS COMPARATIVE STUDY AND ARE SEPARATED BY THE STUDIED AND COMPARED METHODS OF TREATMENT: SPANNING ARTHRODESIS GROUP ¿ ONE (1) PATIENT UNDERWENT PLATE REMOVAL DUE TO PAINFUL HARDWARE. ONE (1) PATIENT UNDERWENT INDEX TO MIDDLE END-TO-SIDE FLEXOR DIGITORUM PROFUNDUS TENODESIS FOLLOWING ATTRITIONAL RUPTURE AT TWELVE (12) WEEKS AFTER IMPLANT. ONE (1) PATIENT UNDERWENT AN OPEN REDUCTION INTERNAL FIXATION (ORIF) AFTER SUSTAINING OPEN DISPLACED PERI-IMPLANT FRACTURES OF THE THIRD METACARPAL AND RADIUS SHAFT AT THE SCREW AND PLATE INTERFACES AFTER A FALL FROM HIS ROOF. ONE (1) PATIENT HAD A BACKED OUT UNKNOWN SCREW CAUSING PAIN IN THE METACARPAL REGION; THIS PATIENT DECLINED HARDWARE REMOVAL. NON-SPANNING ARTHRODESIS GROUP ¿ ONE (1) PATIENT UNDERWENT REMOVAL OF THE PLATE DUE TO CARPOMETACARPAL (CMC) IMPINGEMENT. ONE (1) PATIENT UNDERWENT REMOVAL OF THE PLATE DUE TO BREAKAGE OF AN UNKNOWN SCREW AT THE CAPITATOTRAPEZOID ARTICULATION. ONE (1) PATIENT UNDERWENT REMOVAL OF SCREW DUE TO PROMINENT HARDWARE. IT IS UNKNOWN IF ANY OF THE REPORTED SCREWS IMPLANTED WITH THE TWO SYNTHES PLATES WERE SYNTHES IMPLANTS. ADDITIONALLY, THE AUTHOR EXPLAINED HIM AND HIS TEAM USED THE DEVICES OFF LABEL FOR A WRIST FUSION AND PRODUCTS PERFORMED AS INTENDED. POTENTIALLY ONE OR TWO WERE REMOVED. SINCE THE COMPLAINT INVOLVES TWELVE (12) IMPACTED PRODUCTS IN TOTAL, I.E. FIVE (5) FOR SPANNING ARTHRODESIS TECHNIQUE SEVEN (7) FOR NON-SPANNING ARTHRODESIS TECHNIQUE, THE IMPACTED PRODUCTS CORRESPONDING TO THESE TWO TECHNIQUES WILL BE DISTRIBUTED AMONG THE FOLLOWING TWO PRODUCT COMPLAINTS: (B)(4) WILL REPORT ALL IMPACTED PRODUCTS ASSOCIATED TO SPANNING ARTHRODESIS TECHNIQUE. (B)(4) WILL REPORT ALL IMPACTED PRODUCTS ASSOCIATED TO NON-SPANNING ARTHRODESIS TECHNIQUE. THIS REPORT IS FOR ONE (1) PATIENT UNDERWENT REMOVAL OF THE PLATE DUE TO CARPOMETACARPAL (CMC) IMPINGEMENT. ALSO, THIS REPORT IS FOR UNKNOWN QUANTITY OF UNKNOWN PLATE AND IS REPORT 1 OF 5 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    270623 PLATE,FIXATION,BONE HRS WRIGHTS LANE SYNTHES USA PRODUCTS LLC

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention