BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SCREW, FIXATION, BONE

    MDR report key: 5815939 · Received July 22, 2016

    Report

    Report Number
    2520274-2016-13604
    Event Type
    Injury
    Date Received
    July 22, 2016
    Report Date
    July 8, 2016
    Manufacturer
    SYNTHES USA
    Product Code
    HWC
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. PATIENT DOB NOT PROVIDED FOR REPORTING. UNKNOWN WHEN SCREWS BROKE. THIS REPORT IS FOR (3) UNKNOWN 402.8XX SCREWS/UNKNOWN LOT NUMBER. (B)(4) LOT NUMBER IS UNKNOWN, UDI IS UNAVAILABLE. DEVICE IS EXPECTED TO BE RETURNED TO SYNTHES MANUFACTURER FOR EVALUATION /INVESTIGATION, BUT HAS YET TO BE RECEIVED. (B)(6). (B)(4). THE 510K#: UNKNOWN. SUBJECT DEVICE HAS NOT BEEN RECEIVED. WITHOUT A LOT NUMBER, THE DEVICE HISTORY RECORD REVIEW AND THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED 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

    THREE OF THE FOUR SCREWS IMPLANTED IN THE DISTAL PORTION OF THE PLATE BROKE. THE SCREWS ARE FROM EITHER OF THE TWO FOLLOWING PART FAMILIES: PART FAMILY: 402.8XX ¿ 2.7MM TI CORTEX SCREW SELF-TAPPING (VARYING LENGTHS) ¿ HWC: SCREW, FIXATION, BONE ¿ K112583. PART FAMILY: 04.210.1XX ¿ 2.4MM TI VA LOCKING SCREW STARDRIVE (VARYING LENGTHS) ¿ HWC: SCREW, FIXATION, BONE / HRS: PLATE, FIXATION, BONE ¿ K103243. CORRECTED DATA: WITHOUT A VALID PART AND LOT NUMBER, THE UDI IS NOT AVAILABLE. DEVICE 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

    PRODUCT INVESTIGATION SUMMARY: SIX (6) LOCKING SCREWS WERE RECEIVED FOR EVALUATION. OF THE RETURNED SCREWS, THREE (3) OF THEM WERE BROKEN WITH ONLY THE SHAFTS RETURNED. SINCE THE EXACT ARTICLE AND LOT NUMBERS ARE NOT AVAILABLE, THE PRESENT COMPLAINT CANNOT BE FULLY ANALYZED. FURTHER, THE ACCOMPANYING X-RAY(S) DID NOT PROVIDE CONCLUSIVE EVIDENCE OF ROOT CAUSE. BASED UPON THE MEASURABLE DIMENSIONS (I.E. SHAFT DIAMETER, WHICH MEASURED 2.39MM) AND THE ANODIZED COLOR (GREEN), IT CAN BE CONCLUDED THAT THE BROKEN SCREWS WERE IN FACT 2.4MM LOCKING SCREWS OF PART FAMILY 412.8XX. WITHOUT FURTHER CLINICAL INFORMATION, THE EXACT CAUSE CANNOT BE DETERMINED. HOWEVER, THE COMPLAINED CONDITION IS NOT LIKELY THE RESULT OF ANY PRODUCT-RELATED DEFICIENCIES. THE GENERAL INSTRUCTIONS FOR USE INDICATE THAT THE SELECTION OF THE PROPER IMPLANT IS PARAMOUNT TO REDUCE THE RISK OF IMPLANT BREAKAGE. IN ADDITION, PATIENT-RELATED FACTORS HAVE A STRONG INFLUENCE ON THE SUCCESS OF THE SURGERY. NO DEFINITIVE ROOT CAUSE WAS ABLE TO BE DETERMINED. THIS REPORT IS FOR THREE (3) UNKNOWN SCREWS WITH PARTIAL PART FAMILY 412.8XX. 2.4MM TI LOCKING SCREW SELF-TAPPING W/ STARDRIVE RECESS (UNKNOWN LENGTH) ¿ HRS: PLATE, FIXATION, BONE / HWC: SCREW, FIXATION, BONE ¿ K103243. WITHOUT VERIFICATION OF THE EXACT PART AND LOT NUMBER, THE UDI REMAINS UNKNOWN. DEVICE 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 ON AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT DURING REMOVAL OF THE IMPLANT IT WAS INTRAOPERATIVELY DETECTED THAT 3 SCREW HEADS WERE BROKEN AT THE DISTAL REGION OF THE PLATE. WHICH OF THE 4 DISTAL SCREWS COULD NOT BE FOUND OUT. ALL SCREWS WERE IMPLANTED WITH NEWTON METER LIMITER CONSIDERING ALL SECURITY ASPECTS. TO REMOVE ALL METAL PIECES, IT WAS NEEDED TO DRILL THE BROKEN SCREW, WHICH LED TO A SURGICAL PROLONGATION OF 30 MINUTES. PATIENT IS IN GOOD CONDITION. THIS COMPLAINT INVOLVES 1 PART OF (3) UNKNOWN SCREWS. CONCOMITANT DEVICE: 1X 04.111.520 / LOT UNK (VA-LCP TWO-COLUMN DISTAL RADIUS PLATE 2.4, VOLAR). THIS REPORT IS 1 OF 1 FOR (B)(4).

    Description of Event or Problem · 1

    CLARIFICATION: DEVICE REPORT FROM SYNTHES (B)(4) REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT A PATIENT UNDERWENT A PLANNED REVISION PROCEDURE ON (B)(6) 2016. DURING THIS PROCEDURE, THREE (3) BROKEN SCREWS WERE IDENTIFIED IN THE DISTAL REGION OF THE PLATE. THERE WERE A TOTAL OF FOUR (4) SCREWS IMPLANTED IN THAT REGION, BUT IT IS UNKNOWN WHICH OF THEM BROKE (EITHER FROM PART FAMILY 402.8XX OR 04.210.1XX). THE SCREWS WERE INITIALLY IMPLANTED ON (B)(6) 2015 WITH A NEWTON-METER LIMITER. AS A RESULT, A DRILL WAS NEEDED IN ORDER TO REMOVE THOSE SCREWS AND THEIR FRAGMENTS. THE PROCEDURE WAS EXTENDED BY THIRTY (30) MINUTES. POST-OPERATIVELY, THE PATIENT WAS SAID TO BE IN GOOD CONDITION. CONCOMITANT DEVICE(S) REPORTED: VARIABLE ANGLE 2-COLUMN LOCKING COMPRESSION PLATE (PART: 04.111.520 / LOT: UNKNOWN / QUANTITY: 1). THIS REPORT IS 1 OF 1 FOR COM-(B)(4).

    Description of Event or Problem · 1

    UPDATE: THE INVESTIGATION OF THE RETURNED SCREWS IDENTIFIED THAT THE BROKEN DEVICES BELONGED TO PART FAMILY 412.8XX, NOT 402.8XX AS ORIGINALLY REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    468786 SCREW, FIXATION, BONE HWC SYNTHES USA

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR Required Intervention