BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SCREW, FIXATION, BONE

    MDR report key: 7431104 · Received April 13, 2018

    Report

    Report Number
    2939274-2018-51703
    Event Type
    Injury
    Date Received
    April 13, 2018
    Report Date
    March 22, 2018
    Manufacturer
    WRIGHTS LANE SYNTHES USA PRODUCTS LLC
    Product Code
    HWC
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    PATIENT INFORMATION IS UNKNOWN. SPANNING ARTHRODESIS GROUP ¿ ONE (1) PATIENT UNDERWENT INDEX TO MIDDLE END-TO-SIDE FLEXOR DIGITORUM PROFUNDUS TENODESIS FOLLOWING ATTRITIONAL RUPTURE AT TWELVE (12) WEEKS AFTER IMPLANT. 510K: THIS REPORT IS FOR AN UNKNOWN SCREW/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. PATIENT CODE: (B)(4): SURGICAL INTERVENTION WAS NECESSARY. 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), EMAIL FROM (B)(6) 2018.

    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., & WOLFE, S. W. (2017). NONSPANNING 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 NONSPANNING 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) NONSPANNING ARTHRODESIS WERE PERFORMED BETWEEN (B)(6) 2011 AND (B)(6) 2016, WHEREAS THE TWELVE (12) SPANNING TOTAL WRIST ARTHRODESIS WERE PERFORMED BETWEEN (B)(6) 2002 AND (B)(6) 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, PAOLI, PA), 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 NONSPANNING 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 NONLOCKING 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. NONSPANNING 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. A COPY OF THE LITERATURE ARTICLE WILL BE SUBMITTED WITH THIS MEDWATCH. THIS REPORT IS FOR FOUR (4) IMPACTED PRODUCTS OUT OF A TOTAL OF SIXTEEN (16) IMPACTED PRODUCTS. THIS REPORT IS 2 OF 4 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    270828 SCREW, FIXATION, BONE HWC WRIGHTS LANE SYNTHES USA PRODUCTS LLC

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention