BEUDAMED
    FDA Adverse Event Injury Summary report: N

    5.0MM TI SCHANZ SCREW BLUNTED TROCAR POINT 200MM

    MDR report key: 6212423 · Received December 29, 2016

    Report

    Report Number
    3006126083-2016-10047
    Event Type
    Injury
    Date Received
    December 29, 2016
    Date of Event
    December 1, 2016
    Report Date
    December 5, 2016
    Manufacturer
    SYNTHES RARON
    Product Code
    HWC
    UDI-DI
    07611819035799
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THERAPY DATE: EXACT DATE UNKNOWN; REPORTED AS TWO WEEKS BEFORE EVENT DATE OF (B)(6) 2016. (B)(6). DEVICE IS NOT DISTRIBUTED IN THE UNITED STATES, BUT IS SIMILAR TO DEVICE MARKETED IN THE USA. A REVIEW OF THE DEVICE HISTORY RECORDS HAS BEEN REQUESTED. THE DEVICE WAS RECEIVED, THE INVESTIGATION COULD NOT BE COMPLETED, AND NO CONCLUSION COULD BE DRAWN, AS PRODUCT IS ENTERING THE COMPLAINT SYSTEM. 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

    A PRODUCT INVESTIGATION WAS COMPLETED: THE COMPLAINED DEVICES WERE FORWARDED TO THE RESPONSIBLE PRODUCT UNIT DEPARTMENT FOR EVALUATION. THE RECEIVED CONDITION WAS CLEAN WITH NO VISIBLE DAMAGES EXCEPT ONE SCREW (PART 494.540, LOT 9799776) IS BENT. PER THE TECHNIQUE GUIDE, THE MAXIMUM EXPECTED TEMPERATURE RISE DURING A MRI IS LESS THAN 6°C. BECAUSE HIGHER IN VIVO HEATING CANNOT BE EXCLUDED, CLOSE PATIENT MONITORING AND COMMUNICATION WITH THE PATIENT DURING THE SCAN ARE REQUIRED. IMMEDIATELY ABORTION OF THE SCAN IS RECOMMENDED IF THE PATIENT REPORTS BURNING SENSATION OR PAIN. THE RETURNED DEVICE CAN BE CONSIDERED AS SAFE AND FUNCTIONAL BUT THE COMPLAINT CAN BE RATED AS CONFIRMED AS THE PATIENT REPORTED BURNING PAIN DURING THE MRI PROCEDURE. ALL LISTED CONCOMITANT PARTS WERE STILL INTACT AND DO NOT SHOW ANY DAMAGES. NO INDICATION FOR PRODUCT RELATED ISSUE WAS FOUND. 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.

    Additional Manufacturer Narrative · 1

    MANUFACTURING LOCATION: (B)(4). MANUFACTURING DATE: JULY 29, 2016. NO NON-CONFORMANCE REPORTS WERE GENERATED DURING PRODUCTION. REVIEW OF THE DEVICE HISTORY RECORD(S) SHOWED THAT THERE WERE NO ISSUES DURING THE MANUFACTURE OF THE PRODUCT THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. 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

    DEVICE REPORT FROM SYNTHES EUROPE REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT A PATIENT WITH EXTERNAL FIXATION UNDERWENT A MAGNETIC NUCLEAR RESONANCE. DURING THIS EXAMINATION THE PATIENT FELT BURNING PAIN IN THE AREA OF THE SCHANZ SCREWS. THE EXAMINATION WAS CANCELLED, AND THE IMPLANT WAS REMOVED. IMPLANT DATE WAS TWO WEEKS BEFORE THE EVENT DATE. EXACT DATE IS UNKNOWN; EXPLANT SURGERY WAS ON (B)(6) 2016. THE PATIENT HAD NO HISTORY OF INFECTION OR INFLAMMATION. NO PROLONGATION OF THE SURGERY WAS REPORTED. PATIENT STATUS/OUTCOME IS GOOD. CONCOMITANT MEDICAL PRODUCTS: CARBON FIBER ROD (PART 394.850, LOT 8524314, QUANTITY 1); CARBON FIBER ROD (PART 394.850, LOT 7948360, QUANTITY 1); CARBON FIBER ROD (PART 394.840, LOT 7923803, QUANTITY 1); CARBON FIBER ROD (PART 394.860, LOT 7948359, QUANTITY 1); ROD-TO-ROD CLAMP (PART 390.007, LOT 7493073, QUANTITY 1); ROD-TO-ROD CLAMP (PART 390.007, LOT H099858, QUANTITY 1); ROD-TO-ROD CLAMP (PART 390.007, LOT 9897254, QUANTITY 1); ROD-TO-ROD CLAMP (PART 390.007, LOT 6979527, QUANTITY 1); CLAMP (PART 390.008, LOT 6989718, QUANTITY 1); CLAMP (PART 390.008, LOT 7910586, QUANTITY 1); CLAMP (PART 390.008, LOT 7451378, QUANTITY 1); CLAMP (PART 390.008, LOT 7979826, QUANTITY 1). THIS IS REPORT 3 OF 4 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    863115 5.0MM TI SCHANZ SCREW BLUNTED TROCAR POINT 200MM SCREW, FIXATION, BONE HWC SYNTHES RARON L071062 07611819035799

    Patients

    Seq Age Sex Outcome Treatment
    1 38 YR Required Intervention ONE PART 390.007, LOT 6979527, ROD-TO-ROD CLAMP| ONE PART 390.007, LOT 7493073, ROD-TO-ROD CLAMP| ONE PART 390.007, LOT 9897254, ROD-TO-ROD CLAMP| ONE PART 390.007, LOT H099858, ROD-TO-ROD CLAMP| ONE PART 390.008, LOT 6989718, CLAMP| ONE PART 390.008, LOT 7451378, CLAMP| ONE PART 390.008, LOT 7910586, CLAMP| ONE PART 390.008, LOT 7979826, CLAMP| ONE PART 394.840, LOT 7923803, CARBON FIBER ROD| ONE PART 394.850, LOT 7948360, CARBON FIBER ROD| ONE PART 394.850, LOT 8524314, CARBON FIBER ROD| ONE PART 394.860, LOT 7948359, CARBON FIBER ROD