BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNK - SCREWS: 4.0 MM CANNULATED

    MDR report key: 14592165 · Received June 3, 2022

    Report

    Report Number
    8030965-2022-03651
    Event Type
    Malfunction
    Date Received
    June 3, 2022
    Manufacturer
    SYNTHES GMBH
    Product Code
    HWC
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    DEPUY SYNTHES IS SUBMITTING THIS REPORT PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH DEPUY SYNTHES HAS NOT BEEN ABLE TO INVESTIGATE OR VERIFY PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY FDA, DEPUY SYNTHES OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE DEVICE, DEPUY SYNTHES, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. IF THE INFORMATION IS UNKNOWN, NOT AVAILABLE OR DOES NOT APPLY, THE SECTION/FIELD OF THE FORM IS LEFT BLANK. ADDITIONAL NARRATIVE: THIS REPORT IS FOR AN UNKNOWN SCREWS: 4.0 MM CANNULATED/UNKNOWN LOT. PART AND LOT NUMBER ARE UNKNOWN. WITHOUT THE SPECIFIC PART NUMBER; THE UDI NUMBER AND 510-K NUMBER IS UNKNOWN. D9: 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. PRODUCT WAS NOT RETURNED. BASED ON THE INFORMATION AVAILABLE, IT HAS BEEN DETERMINED THAT NO CORRECTIVE AND/OR PREVENTATIVE ACTION IS PROPOSED. THIS COMPLAINT WILL BE ACCOUNTED FOR AND MONITORED VIA POST MARKET SURVEILLANCE ACTIVITIES. IF ADDITIONAL INFORMATION IS MADE AVAILABLE, THE INVESTIGATION WILL BE UPDATED AS APPLICABLE. 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 · 0

    DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN THE UNITED KINGDOM AS FOLLOWS: THIS REPORT IS BEING FILED AFTER THE REVIEW OF THE FOLLOWING JOURNAL ARTICLE: LEVENE A.P., TEMPLETON P., (2008) PREVIOUSLY UNREPORTED FAILURE OF A SYNTHES 4.0 MM DIAMETER CANNULATED SCREW, INJURY EXTRA VOLUME 39, PAGES 212¿215 (UNITED KINGDOM) THIS STUDY PRESENTS A CASE REPORT OF A PREVIOUSLY UNRECORDED FAILURE OF THE SYNTHES 4.0 MM DIAMETER CANNULATED SCREW SYSTEM THAT OCCURRED DURING SCREW INSERTION. A 38-YEAR-OLD GENTLEMAN PRESENTED TO ACCIDENT AND EMERGENCY WITH A 2-WEEK-OLD INJURY TO HIS LEFT ELBOW. ON EXAMINATION HE HAD MINIMAL TENDERNESS OVER THE LATERAL ASPECT OF HIS ELBOW AND A FIXED FLEXION DEFORMITY OF 608, WHICH COULD BE INCREASED TO 1208 ON PASSIVE MOVEMENT OF THE ELBOW, ALTHOUGH THIS DID ELICIT A LARGE DEGREE OF PAIN. X-RAYS OF THE GENTLEMAN¿S LEFT ELBOW SHOWED A DISPLACED LATERAL EPICONDYLE FRACTURE OF THE HUMERUS. THE PATIENT UNDERWENT OPEN REDUCTION AND INTERNAL FIXATION OF THE FRACTURED LEFT EPICONDYLE USING A 50 MM PARTIALLY THREADED SYNTHES 4.0 MM DIAMETER CANNULATED SCREW, AS THE SCREW WAS BEING INSERTED, IT WAS COMPLETELY UNCOILED AND COLLAPSED AND BROKE, LEAVING THE DISTAL THREADED END OF THE SCREW IN THE GENTLEMAN¿S ELBOW. THE WOUND WAS OPENED AND THE BROKEN PART OF THE SCREW WAS NOT PALPABLE. IT WAS DECIDED TO LEAVE IT. TWO 4.0 MM DIAMETER CANCELLOUS PARTIALLY THREADED SMALL FRAGMENT SCREWS WERE INSERTED AND CHECK X-RAYS SHOWED A SATISFACTORY REDUCTION OF THE FRACTURE, AND ALSO THE BROKEN COLLAPSED DISTAL THREADED END OF THE CANNULATED SCREW. THE PATIENT WAS REVIEWED ON THE WARD THE NEXT MORNING AND WAS FOUND TO HAVE A GOOD NEUROVASCULAR FUNCTION. HE WAS DISCHARGED AND RETURNED TO THE CLINIC 6 DAYS LATER WHERE THE. ABOVE ELBOW BACKSLAB WAS REMOVED AND THE WOUND INSPECTION WAS FINE. HE WAS RE-FITTED WITH AN ABOVE ELBOW SPLIT CAST AND ADVISED TO KEEP AN APPOINTMENT FOR 2 WEEKS TIME. HOWEVER, THE PATIENT RETURNED TO THE CLINIC 8 DAYS LATER WHERE A REPEAT A-P AND LATERAL X-RAY SHOWED GOOD HEALING OF THE FRACTURE AND NO SYMPTOMS FROM THE BROKEN COLLAPSED DISTAL THREADED END OF THE CANNULATED SCREW. IN THE FINAL CLINIC APPOINTMENT, THE PATIENT HAD A 208 FIXED FLEXION CONTRACTURE BUT GOOD FLEXION AND FOREARM ROTATION. HE WAS THEN DISCHARGED. (THE PROXIMAL END OF THE CANNULATED SCREW WAS SENT BACK TO SYNTHES HEAD OFFICE IN SWITZERLAND FOR LABORATORY TESTING TO ASCERTAIN THE CAUSE OF THE SCREW FAILURE .THE MANUFACTURING PAPERS AND RAW MATERIAL TESTING CERTIFICATE SHOWED THAT PRIOR TO USING THE MATERIAL ANALYSIS, STRENGTH AND STRUCTURAL STABILITY OF THE SCREW WERE ALL IN COMPLIANCE WITH AO/ASIF SPECIFICATIONS AND WITH THE INTERNATIONAL STANDARD. THE BROKEN SCREW THAT WAS SENT TO THEMSELVES DID NOT SHOW ANY IRREGULARITIES ON THE CROSS-SECTION SURFACE AND THEY COULD NOT DETECT ANY PRODUCT FAULT.) THIS REPORT IS FOR AN UNKNOWN SYNTHES 4.0 MM DIAMETER CANNULATED SCREW SYSTEM. A COPY OF THE LITERATURE ARTICLE IS BEING SUBMITTED WITH THIS REPORT. THIS IS REPORT 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1801372 UNK - SCREWS: 4.0 MM CANNULATED SCREW, FIXATION, BONE HWC SYNTHES GMBH

    Patients

    Seq Age Sex Outcome Treatment
    1 38 YR Unknown