BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    2.4MM TI VA LOCKING SCREW STARDRIVE 12MM-STERILE

    MDR report key: 11067015 · Received December 23, 2020

    Report

    Report Number
    8030965-2020-09945
    Event Type
    Malfunction
    Date Received
    December 23, 2020
    Date of Event
    November 24, 2020
    Report Date
    November 26, 2020
    Manufacturer
    SYNTHES GMBH
    Product Code
    HRS
    UDI-DI
    07611819980631
    PMA / PMN Number
    K102694
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    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. H3, H6: STERILE PART: PART: 04.210.112S, LOT: 7L22106, MANUFACTURING SITE: SELZACH, SUPPLIER: (B)(4), RELEASE TO WAREHOUSE DATE: AUGUST 28, 2020, EXPIRY DATE: AUGUST 01, 2030. SINCE THERE IS NO ALLEGATION AGAINST PACKING OR STERILITY, A MANUFACTURING RECORD EVALUATION WAS NOT PERFORMED. NON-STERILE PART: PART: 04.210.112, SYNTHES LOT: 50P3310, SUPPLIER LOT: 50P3310, RELEASE TO WAREHOUSE DATE: MARCH 26, 2020, MANUFACTURING SITE: SYNTHES USA HQ, INC, SUPPLIER: (B)(4). NO NONCONFORMANCE REPORTS (NCRS) WERE GENERATED DURING PRODUCTION. REVIEW OF THE DEVICE HISTORY RECORD(S) SHOWED THAT THERE WERE NO ISSUES DURING THE MANUFACTURE OF THIS PRODUCT, AND ANY SUB-COMPONENTS, WHICH WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. VISUAL INSPECTION: THE THREAD AT THE HEAD OF THE RETURNED VA LOCKING SCREW LOOKS STRIPPED AND DEFORMED. THEREFORE, THE COMPLAINT IS RATED AS CONFIRMED FOR THESE SCREWS. DIMENSIONAL INSPECTION: DUE TO THE DAMAGES, THE RELEVANT DIMENSION COULD NOT BE MEASURED. HOWEVER, THE PART CONFORMED TO DIMENSIONAL SPECIFICATIONS AT THE TIME OF MANUFACTURING AND PASSED INSPECTION REQUIREMENTS. DOCUMENT/SPECIFICATION REVIEW: THE MANUFACTURING REVIEW SHOWS THAT THE PRODUCTION PROCEDURES WERE ACCORDING TO THE SPECIFICATIONS AND THERE WERE NO ISSUES THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. THE INVESTIGATION HAS SHOWN THAT THE CAUSE OF COMPLAINED MALFUNCTION IS A POST-MANUFACTURING CAUSED USE RELATED DAMAGE AT THE DEVICE. SUMMARY: THE COMPLAINT IS RATED AS CONFIRMED FOR THIS VA LOCKING SCREW. WE DO SUPPOSE THAT THE DEVICE ENCOUNTERED UNINTENDED FORCES, SUCH AS EXCESSIVE FORCE APPLICATION DURING INSERTION SURGERY WHICH FINALLY CAUSED THE POST MANUFACTURING DAMAGES. THESE COULD BE: WRONG TORQUE OR ANGULATION OF SCREWING DURING INSERTION IN THE PLATE WHICH COULD LEAD TO THE COMPLAINT CONDITION. DURING THE INVESTIGATION, NO PRODUCT DESIGN OR MANUFACTURING ISSUES WERE OBSERVED THAT MAY HAVE CONTRIBUTED TO THE COMPLAINT CONDITION; THEREFORE, FURTHER CORRECTIVE AND/OR PREVENTIVE ACTION IS NOT REQUIRED. ADDITIONAL MONITORING FOR ANY POTENTIAL SAFETY SIGNALS WILL BE CONDUCTED THROUGH COMPLAINT TRENDING AND OTHER POST MARKET SAFETY SURVEILLANCE ACTIVITIES. BASED ON THE INVESTIGATION FINDINGS, IT HAS BEEN DETERMINED THAT NO CORRECTIVE AND/OR PREVENTATIVE ACTION IS PROPOSED AS NO PRODUCT RELATED ISSUE COULD BE DETECTED. 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. H3, H6- THE THREAD AT THE HEAD OF THE RETURNED VA LOCKING SCREW LOOKS STRIPPED AND DEFORMED. THEREFORE THE COMPLAINT IS RATED AS CONFIRMED FOR THESE SCREWS. THE COMPLAINT IS RATED AS CONFIRMED FOR THIS VA LOCKING SCREW. WE DO SUPPOSE THAT THE DEVICE ENCOUNTERED UNINTENDED FORCES, SUCH AS EXCESSIVE FORCE APPLICATION DURING INSERTION SURGERY WHICH FINALLY CAUSED THE POST MANUFACTURING DAMAGES. THESE COULD BE: WRONG TORQUE OR ANGULATION OF SCREWING DURING INSERTION IN THE PLATE WHICH COULD LEAD TO THE COMPLAINT CONDITION. DURING THE INVESTIGATION, NO PRODUCT DESIGN OR MANUFACTURING ISSUES WERE OBSERVED THAT MAY HAVE CONTRIBUTED TO THE COMPLAINT CONDITION; THEREFORE, FURTHER CORRECTIVE AND/OR PREVENTIVE ACTION IS NOT REQUIRED. ADDITIONAL MONITORING FOR ANY POTENTIAL SAFETY SIGNALS WILL BE CONDUCTED THROUGH COMPLAINT TRENDING AND OTHER POST MARKET SAFETY SURVEILLANCE ACTIVITIES. BASED ON THE INVESTIGATION FINDINGS, IT HAS BEEN DETERMINED THAT NO CORRECTIVE AND/OR PREVENTATIVE ACTION IS PROPOSED AS NO PRODUCT RELATED ISSUE COULD BE DETECTED. DEVICE HISTORY LOT : STERILE PART: PART: 04.210.112S, LOT: 7L22106, MANUFACTURING SITE: SELZACH, SUPPLIER: (B)(4), RELEASE TO WAREHOUSE DATE: 28.AUG.2020. EXPIRY DATE: 01.AUG.2030. SINCE THERE IS NO ALLEGATION AGAINST PACKING OR STERILITY, A MANUFACTURING RECORD EVALUATION WAS NOT PERFORMED. NON-STERILE PART: PART # 04.210.112, SYNTHES LOT NUMBER: 50P3310, SUPPLIER LOT NUMBER: 50P3310, RELEASE TO WAREHOUSE DATE: 26.MAR.2020, MANUFACTURING SITE: SYNTHES USA HQ, INC, SUPPLIER: (B)(4), NO NCR¿S WERE GENERATED DURING PRODUCTION. PART NUMBER: 04.210.112S, LOT NUMBER: 6L35310, PART/LOT COMBINATION ARE UNKNOWN AT SYNTHES GMBH, NO DHR REVIEW POSSIBLE. REVIEW OF THE DEVICE HISTORY RECORD(S) SHOWED THAT THERE WERE NO ISSUES DURING THE MANUFACTURE OF THIS PRODUCT, AND ANY SUB-COMPONENTS, WHICH 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.

    Additional Manufacturer Narrative · 1

    COMPLAINANT PART IS EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION BUT HAS YET TO BE RECEIVED. THE INVESTIGATION COULD NOT BE COMPLETED, NO PRODUCT WAS RECEIVED; NO CONCLUSION COULD BE DRAWN AT THE TIME OF FILING THIS REPORT. 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 (B)(6) REPORTS AN EVENT AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2020, THE PATIENT UNDERWENT THE SURGERY. DURING THE SURGERY, THE SCREW COULDN'T BE LOCKED TO THE PLATE. A NEW SCREW WAS INSERTED THE SAME HOLE. THE SURGERY WAS COMPLETED SUCCESSFULLY WITHIN 30 MINUTES DELAY. THE PATIENT OUTCOME WAS UNKNOWN. CONCOMITANT DEVICE REPORTED: UNK - PLATE: (PART# UNKNOWN; LOT# UNKNOWN; QUANTITY: 1). THIS COMPLAINT INVOLVES ONE DEVICE. THIS REPORT IS FOR (1) 2.4MM TI VA LOCKING SCREW STARDRIVE 12MM-STERILE THIS REPORT IS 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1526822 2.4MM TI VA LOCKING SCREW STARDRIVE 12MM-STERILE PLATE,FIXATION,BONE HRS SYNTHES GMBH 6L35310 07611819980631

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK - PLATES