BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SCREW,FIXATION,BONE

    MDR report key: 6631213 · Received June 9, 2017

    Report

    Report Number
    2520274-2017-11788
    Event Type
    Injury
    Date Received
    June 9, 2017
    Report Date
    May 18, 2017
    Manufacturer
    SYNTHES MONUMENT
    Product Code
    HWC
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL PRODUCT CODE: HRS. K113364. THIS REPORT IS FOR FIVE (5) UNKNOWN 2.7MM CORTEX SCREWS. IT IS UNKNOWN WHICH FIVE (5) SCREWS OF THE TEN (10) IMPLANTED SCREWS BROKE. THE FOLLOWING PART NUMBERS WERE PROVIDED: 2.7MM CORTEX SCREW SLF-TPNG WITH T8 STARDRIVE RECESS 20MM, PART 202.880, G5: K113364 2.7MM CORTEX SCREW SELF-TAPPING 18MM, PART 212.818, G5: K113364 2.7MM CORTEX SCREW SELF-TAPPING 20MM, PART 212.820, G5: K102694, QUANTITY 2 2.7MM CORTEX SCREW SELF-TAPPING 22MM, PART 212.822, G5: K103243, QUANTITY 2 2.7MM CORTEX SCREW SELF-TAPPING 12MM, PART 212.812, G5: K103243, QUANTITY 2 2.7MM CORTEX SCREW SLF-TPNG WITH T8 STARDRIVE RECESS 14MM, PART 202.874, G5: K113364 2.7MM CORTEX SCREW SLF-TPNG WITH T8 STARDRIVE RECESS 16MM, PART 202.876, G5: K113364. A PRODUCT INVESTIGATION WAS COMPLETED: FIVE SCREWS WERE REPORTED WITH THE COMPLAINT CATEGORY OF ¿BROKEN : POSTOPERATIVELY.¿ THE DEVICES WERE NOT RETURNED FOR INVESTIGATION BUT MEDICAL IMAGING AND POSTOPERATIVE PHOTOS WERE RECEIVED. A VISUAL INSPECTION VIA THE PROVIDED IMAGING WAS PERFORMED AS PART OF THIS INVESTIGATION. THE COMPLAINT CONDITION WAS CONFIRMED. NO DEFINITIVE ROOT CAUSE WAS ABLE TO BE DETERMINED WITH THE PROVIDED INFORMATION AND SINCE THE DEVICES WERE NOT RECEIVED FOR PHYSICAL EVALUATION. DURING THE INVESTIGATION NO PRODUCT ISSUES WERE OBSERVED THAT MAY HAVE CONTRIBUTED TO THE COMPLAINT CONDITION. THE RISK ASSESSMENT WAS FOUND TO ADEQUATELY ADDRESS THE COMPLAINT CONDITION. NO NEW MALFUNCTIONS WERE OBSERVED DURING THE COURSE OF THIS INVESTIGATION. THE X-RAYS RECEIVED SHOW THE IMPLANTED PLATE AND SCREWS. FOUR SCREWS WERE OBSERVED IN THE SHAFT OF THE PLATE AND APPEAR INTACT. MULTIPLE SCREWS WERE OBSERVED IN THE HEAD OF THE PLATE. A DEFINITIVE NUMBER OF SCREW IN THE HEAD OF THE PLATE AND THE CONDITION OF THE SCREWS COULD NOT BE DETERMINED BASED ON THE VIEW OF THE X-RAY. HOWEVER, AT LEAST TWO SCREWS COULD BE IDENTIFIED AS BROKEN. BASED ON THE PROVIDED IMAGING, THE COMPLAINT CONDITION IS CONFIRMED AND CONSISTENT WITH THE REPORTED CONDITION. REPLICATION OF THIS COMPLAINT CONDITION IS NOT APPLICABLE AS THE DEVICES ARE ALREADY BROKEN AND WERE NOT RECEIVED. BASED ON THE PROVIDED IMAGES IT CAN ALSO BE CONCLUDED THAT IT IS PROBABLE THAT THE FIVE BROKEN SCREWS WERE FIVE LOCKING SCREWS IN THE HEAD OF THE PLATE. HOWEVER, FROM ONLY THE PROVIDED IMAGES, THE PART NUMBERS COULD NOT BE DEFINITIVELY DETERMINED. AS THE PHYSICAL DEVICES WERE NOT RECEIVED NO FURTHER DIMENSIONAL OR MATERIAL TESTING COULD BE COMPLETED AND THE DEVICES COULD NOT BE INSPECTED TO THE DRAWING SPECIFICATION. AS THE LOT NUMBERS WERE NOT PROVIDED A REVIEW OF THE DEVICE HISTORY RECORDS COULD NOT BE REVIEWED. 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

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A REVISION OF AN OPEN REDUCTION AND INTERNAL FIXATION (ORIF) OF THE LEFT DISTAL RADIUS ON (B)(6) 2017 DUE TO A DELAYED/MALUNION UNION AND FIVE (5) BROKEN CORTEX SCREWS. IT IS UNKNOWN WHAT CAUSED THE BREAKAGE. THE SCREWS HAD BROKEN AT THE NECK OF THE SCREWS JUST BELOW THE PLATE INTERFACE. THERE WAS NO MALFUNCTION OF THE PLATE. ALL OF THE HARDWARE, INCLUDING ONE (1) PLATE, FIVE (5) BROKEN DISTAL LOCKING SCREWS, AND FIVE (5) ADDITIONAL SCREWS WERE REMOVED INTACT. THE PATIENT WAS REVISED TO A COMPETITOR¿S PLATE AND SCREWS. NO SURGICAL DELAY OR PATIENT HARM. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. PATIENT OUTCOME WAS STABLE. THE PATIENT WAS INITIALLY IMPLANTED WITH HARDWARE FOR AN OPEN LEFT DISTAL RADIUS FRACTURE DUE TO A FALL DOWN STAIRS, ON (B)(6) 2017, AT A DIFFERENT FACILITY BY A DIFFERENT SURGEON. PATIENT OUTCOME IN THE INITIAL SURGERY WAS STABLE. ON (B)(6) 2017, THE PATIENT WAS SEEN FOR A POST-OPERATIVE EXAM. IT WAS NOTED AT HIS LAST VISIT HE HAD LOSS OF FIXATION AND ALIGNMENT WITH LOSS OF PALMAR TILT AND SHORTENING OF THE RADIUS. THE PATIENT REPORTED IMPROVING MOTION BUT REPORTED PAIN AT THE DISTAL RADIOULNAR JOINT (DRUJ) AREA AND TENDERNESS OVER HIS DISTAL RADIUS. X-RAYS WERE TAKEN AT THE VISIT AND REVEALED LOSS OF FIXATION ALIGNMENT WITH LOSS OF VOLAR TILT, SHORTENING OF THE RADIUS AND EVIDENCE OF HARDWARE FRACTURE AT THE SCREW-PLATE JUNCTION. THE SURGEON HAD RECOMMENDED THE PATIENT UNDERGO A REVISION OF INTERNAL FIXATION WITH RESTORATION OF RADIAL LENGTH AND ALIGNMENT WHICH LED TO THE (B)(6) 2017 REVISION. CONCOMITANT DEVICES REPORTED: LOCKING COMPRESSION PLATE (LCP) DISTAL RADIUS PLATE EXTRA-ARTICULAR/LEFT-LONG (PART 242.462, LOT M143777, QUANTITY 1), 2.7MM CORTEX SCREW SELF-TAPPING (PART UNKNOWN, LOT UNKNOWN, QUANTITY 5) THIS REPORT IS FOR FIVE (5) UNKNOWN 2.7MM CORTEX SCREWS.

    Additional Manufacturer Narrative · 1

    PATIENT WEIGHT NOT AVAILABLE FOR REPORTING. DATE OF DEVICE BREAKAGE AND DELAYED UNION IS NOT KNOWN. 510K: THIS REPORT IS FOR FIVE (5) UNKNOWN DISTAL LOCKING SCREWS. PART AND LOT NUMBERS 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 INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. 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.

    Additional Manufacturer Narrative · 1

    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

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A REVISION OF AN OPEN REDUCTION AND INTERNAL FIXATION (ORIF) OF THE DISTAL RADIUS ON (B)(6) 2017 DUE TO A DELAYED UNION AND FIVE (5) BROKEN SCREWS. IT IS UNKNOWN WHAT CAUSED THE BREAKAGE. THERE WAS NO MALFUNCTION OF THE PLATE. ALL OF THE HARDWARE, INCLUDING ONE (1) PLATE, AND FIVE (5) BROKEN UNKNOWN DISTAL LOCKING SCREWS WERE REMOVED. THE PATIENT WAS REVISED TO A COMPETITOR¿S PLATE AND SCREWS. NO SURGICAL DELAY OR PATIENT HARM. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. PATIENT OUTCOME IS STABLE. THE PATIENT WAS INITIALLY IMPLANTED WITH THE HARDWARE FOR AN OPEN DISTAL RADIUS FRACTURE ON AN UNKNOWN DATE AT A DIFFERENT FACILITY BY A DIFFERENT SURGEON. CONCOMITANT DEVICES REPORTED: LOCKING COMPRESSION PLATE (LCP) DISTAL RADIUS PLATE EXTRA-ARTICULAR/LEFT-LONG (PART 242.462, LOT M143777, QUANTITY 1) THIS REPORT IS FOR FIVE (5) UNKNOWN DISTAL LOCKING SCREWS THIS IS REPORT 1 OF 1 FOR (B)(4)..

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    413313 SCREW,FIXATION,BONE HWC SYNTHES MONUMENT

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention 1 LCP (PART 242.462, LOT M143777)| 5 UNKNOWN 2.7MM CORTEX SCREWS| PLATE (242.462, LOT M143777, QTY 1)