BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    1.8MM TI VA LCKNG BUTTRESS PIN WITH T8 STARDRIVE RECESS/22MM

    MDR report key: 7140382 · Received December 21, 2017

    Report

    Report Number
    8030965-2017-50936
    Event Type
    Malfunction
    Date Received
    December 21, 2017
    Date of Event
    November 27, 2017
    Report Date
    November 27, 2017
    Manufacturer
    OBERDORF : SYNTHES PRODUKTIONS GMBH
    Product Code
    HWC
    UDI-DI
    07611819420236
    PMA / PMN Number
    K102694
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE HISTORY RECORD REVIEW WAS PERFORMED FOR THE SUBJECT DEVICE: PART NUMBER: 04.210.092S, LOT NUMBER: L033256. MANUFACTURING LOCATION: (B)(4), SUPPLIER: (B)(4). RELEASE TO WAREHOUSE DATE: 23.JUN.2016 EXPIRY DATE: 01.JUN.2026. NO NCRS 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. NON-STERILE 04.210.092 / 7801225 WAS MANUFACTURED IN US. MANUFACTURING LOCATION: (B)(4). MANUFACTURING DATE: 23-SEP-2014 PART NO: 04.210.092, LOT NO: 7801225 (NON-STERILE) ¿ 1.8MM TI VA LCKNG BUTTRESS PIN WITH T8 STARDRIVE RECESS/22MM. QUANTITY (B)(4). COMPONENTS REVIEWED: RAW MATERIAL PART 04.211.032.999, 2.8MM TI SCREW BLANK 32MM. BP55, LOT 7786062 MEET SPECIFICATION. LOT WAS RELEASED TO BP55 ON 29-AUG-2014. INSPECTION SHEET FOR FINAL INSPECTION MEETS INSPECTION ACCEPTANCE CRITERIA. NO NCRS WERE GENERATED DURING PRODUCTION. REVIEW OF THE DEVICE HISTORY RECORD(S) SHOWED THAT THERE WERE NO ISSUES DURING THE MANUFACTURE OF THIS 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.

    Additional Manufacturer Narrative · 1

    PATIENT INFORMATION NOT AVAILABLE FOR REPORTING. ADDITIONAL PRODUCT CODE: HRS. DEVICE WAS NOT EXPLANTED. COMPLAINANT PART IS NOT EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED. 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 PATIENT UNDERWENT SURGERY FOR A DISTAL RADIUS FRACTURE ON (B)(6) 2017. ALTHOUGH THE SURGEON INSERTED THE BUTTRESS PIN TO THE SCREW HOLE OF THE PLATE IN THE VARIABLE ANGLE MODE AFTER BENDING THAT SCREW HOLE ON THE RADIAL SIDE AT THE DISTAL SECOND ROW, THE BUTTRESS PIN WAS NOT LOCKED WITH THE PLATE. THE SURGEON COMMENTED THAT THIS EVENT OCCURRED BECAUSE THE SCREW HOLE MIGHT HAVE BEEN DEFORMED DUE TO BENDING, THE SCREW HOLE MIGHT BE DAMAGED DURING DRILLING, OR THE SURGEON MIGHT HAVE APPLIED MORE THAN THE 15-DEGREE ANGLE FOR SOME REASONS. THE SURGERY WAS EXTENDED FOR 10 MINUTES. THE UNLOCKED SCREW REMAINS IN THE PATIENT. THIS IS REPORT 2 OF 2 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    918786 1.8MM TI VA LCKNG BUTTRESS PIN WITH T8 STARDRIVE RECESS/22MM SCREW, FIXATION, BONE HWC OBERDORF : SYNTHES PRODUKTIONS GMBH L033256 07611819420236

    Patients

    Seq Age Sex Outcome Treatment
    1