BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNK - SCREWS: 2.7 MM VA LOCKING

    MDR report key: 18821553 · Received March 1, 2024

    Report

    Report Number
    8030965-2024-03108
    Event Type
    Malfunction
    Date Received
    March 1, 2024
    Manufacturer
    SYNTHES GMBH
    Product Code
    HWC
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    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. D1: THIS REPORT IS FOR AN UNKNOWN 2.7MM VARIABLE ANGLE (VA) LOCKING SCREW/UNKNOWN LOT. IT IS UNKNOWN WHICH SPECIFIC SCREW BROKE, ALTHOUGH THE POTENTIAL PART NUMBERS OF THE SCREWS ARE 04.211.016TS OR 04.211.018TS. D4: POTENTIAL UDI NUMBERS FOR 04.211.016TS OR 04.211.018TS ARE (B)(4). G4 510K: K103243 D9: COMPLAINANT PART IS NOT EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION. H3, H4, H6: 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. 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.

    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. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED ARTICLE LOT AND NO NON-CONFORMANCES WERE IDENTIFIED. PART: 04.211.014TS. LOT: 9L80024. MANUFACTURING SITE: WERK SELZACH. SUPPLIER: (B)(4). RELEASE TO WAREHOUSE DATE: 07 SEP 2022. EXPIRATION DATE: 01 SEP 2027. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED ARTICLE LOT AND NO NON-CONFORMANCES WERE IDENTIFIED. NON-STERILE PART # 04.211.014. NON-STERILE LOT #1465P52. MANUFACTURING SITE: WERK SELZACH. SUPPLIER:(B)(4). RELEASE TO WAREHOUSE DATE:12 AUG 2022. PRODUCT WAS NOT RETURNED. BASED ON THE INFORMATION AVAILABLE, IT HAS BEEN DETERMINED THAT NO CORRECTIVE AND 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. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THIS MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Description of Event or Problem · 0

    DEVICE REPORT FROM DEPUY SYNTHES REPORTS AN EVENT IN JAPAN AS FOLLOWS: IT WAS REPORTED THAT ON JUNE 16, 2023, THE PATIENT UNDERWENT OPEN REDUCTION INTERNAL FIXATION (ORIF) WITH A VARIABLE ANGLE-LOCKING COMPRESSION (VA-LCP) PLATE FOR CLAVICLE DIAPHYSEAL FRACTURE. ON (B)(6) 2024 REMOVAL PROCEDURE WAS PERFORMED AS BONE-UNION WAS ACHIEVED. DURING THE REMOVAL OF THE PLATE, A THIRD PROXIMAL SCREW HEAD PORTION WAS DISCOVERED AS BROKEN OFF SITUATION, AND THERE WAS A THREAD PART REMAINED IN PATIENT¿S BONE. EVEN PICKING IT UP BY A FORCEPS WAS UNSUCCESSFUL, AND THUS, THERE WAS THE ONLY SCREW LEFT IN PATIENT¿S BODY, THE REVISION SURGERY ENDED WITHIN ADDITIONAL THIRTY (30) MINUTES. ACCORDING TO A SURGEON, DUE TO FEAR OF SECONDARY FRACTURE, REMOVAL OF THE SCREW IN QUESTION WAS NOT CONDUCTED. PATIENT OUTCOME IS REPORTED AS STABLE. NO FURTHER INFORMATION IS AVAILABLE. THIS REPORT IS FOR AN UNKNOWN 2.7MM VA LOCKING SCREW. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    212750 UNK - SCREWS: 2.7 MM VA LOCKING SCREW, FIXATION, BONE HWC SYNTHES GMBH

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown VA LOCKSCR ø2.7 HE 2.4 SELF-TAP L14 TAN.| VA LOCKSCR ø2.7 HE 2.4 SELF-TAP L16 TAN.| VA LOCKSCR ø2.7 HE 2.4 SELF-TAP L16 TAN.| VA LOCKSCR ø2.7 HE 2.4 SELF-TAP L16 TAN.| VA LOCKSCR ø2.7 HE 2.4 SELF-TAP L16 TAN.| VA LOCKSCR ø2.7 HE 2.4 SELF-TAP L18 TAN.| VA LOCKSCR ø2.7 HE 2.4 SELF-TAP L18 TAN.| VA-LCP CLAVIC PL 2.7 SHAFT CS3 R TAN.