BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    2.7MM TI VA LCKNG SCR SLF-TPNG WITH T8 STARDRIVE RECESS 14MM

    MDR report key: 9492301 · Received December 19, 2019

    Report

    Report Number
    8030965-2019-71242
    Event Type
    Malfunction
    Date Received
    December 19, 2019
    Date of Event
    December 3, 2019
    Report Date
    December 3, 2019
    Manufacturer
    OBERDORF SYNTHES PRODUKTIONS GMBH
    Product Code
    HWC
    UDI-DI
    07611819425231
    PMA / PMN Number
    K103243
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL DEVICE PRODUCT CODE: HRS. COMPLAINANT PART IS NOT EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION. A DEVICE HISTORY RECORD (DHR) REVIEW WAS CONDUCTED: THIS MRE REVIEW IS FOR STERILIZATION PROCEDURE ONLY. PART: 04.211.014S, LOT: 4L50948, MANUFACTURING SITE: (B)(4), SUPPLIER: (B)(4), RELEASE TO WAREHOUSE DATE: 03.MAY 2019, EXPIRY DATE: 01.APRIL 2029. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE LOT NUMBER, AND NO NON-CONFORMANCE'S WERE IDENTIFIED. NON-STERILE PART WAS MANUFACTURED IN (B)(4). PART: 04.211.014, LOT: H844375, PART NUMBER: 04.211.014, 2.7MM TI VA LCKNG SCR SLF-TPNG WITH T8 STARDRIVE RECESS 14MM, LOT NUMBER: H844375 (NON-STERILE), LOT QUANTITY: 233. WORK ORDER TRAVELER MET ALL INSPECTION ACCEPTANCE CRITERIA. THIS LOT MET ALL DIMENSIONAL, VISUAL AND PACKAGING CRITERIA AT THE TIME OF RELEASE WITH NO ISSUES DOCUMENTED DURING THE MANUFACTURE THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. COMPONENT(S) REVIEWED: PART NUMBER: 04.211.014.999 2.8MM TI SCREW BLANK 14MM 02.7 VARIABLE ANGLE W/SD8, LOT NUMBER: H791587, LOT QUANTITY: 954, WORK ORDER TRAVELER MET ALL INSPECTION ACCEPTANCE CRITERIA. PART NUMBER: 23032, TIALNBCI2.78, LOT NUMBER: H574287, LOT QUANTITY: 603 LBS. NON-CONFORMANCE WAS INITIATED AGAINST THIS LOT FOR MISSING INFORMATION ON THE SUPPLIER CERTIFICATION (MISSING SHIP DATE). THE DISPOSITION OF THE NR WAS ¿REWORK¿ AND A CORRECTED CERTIFICATION WAS SUPPLIED. CERTIFIED TEST REPORT (CORRECTED) SUPPLIED BY (B)(4) DATED 06-FEB-2018 WAS REVIEWED AND DETERMINED TO BE CONFORMING. LOT SUMMARY REPORT DATED 09-MAR-2018 MET ALL INSPECTION ACCEPTANCE CRITERIA. RAW MATERIAL RECEIVING/PUTAWAY CHECKLIST MET ALL INSPECTION ACCEPTANCE CRITERIA. THIS LOT MET ALL DIMENSIONAL, VISUAL AND PACKAGING CRITERIA AT THE TIME OF RELEASE WITH NO ISSUES DOCUMENTED DURING THE MANUFACTURE THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. 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 · 1

    DEVICE REPORT FROM SYNTHES REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON (B)(6) 2019, THE PATIENT UNDERWENT AN OPEN REDUCTION INTERNAL FIXATION SURGERY FOR THE PROXIMAL ULNA FRACTURE WITH THE SCREWDRIVER IN QUESTION. DURING THE SURGERY, THE SURGEON COULD NOT INSERT THE LOCKING SCREW INTO THE BONE COMPLETELY BECAUSE THE HEAD OF THE LOCKING SCREWS WERE GETTING WORN-OUT. THE TORQUE LIMITATION MECHANISM SEEMED NOT TO BE WORKING PROPERLY. BOTH THE SURGEON AND A SUPERVISING PHYSICIAN TRIED TO INSERT VERY CAREFULLY, BUT THE PROBLEM DIDN'T IMPROVE. THE SURGERY WAS COMPLETED WITH THE SCREW INSERTED INCOMPLETELY. IT IS UNKNOWN OUT OF SIX SCREWS WHICH SCREW WAS INSERTED INCOMPLETELY. THE SURGERY WAS DELAYED BY LESS THAN THIRTY (30) MINUTES. THE SURGEON COMMENTED THAT THERE IS A POSSIBILITY THAT EITHER THE CONNECTION OF THE SCREWDRIVER AND THE SCREW WAS INCOMPLETE OR THE TORQUE LIMITING ATTACHMENT WAS DEFECTIVE. THE SURGEON WORRIES THAT THE SCREW MAY COME OUT BECAUSE OF THE INCOMPLETE INSERTION. NO FURTHER INFORMATION IS AVAILABLE. CONCOMITANT DEVICE REPORTED: UNKNOWN PLATE (PART # UNKNOWN, LOT # UNKNOWN, QUANTITY 1). THIS REPORT IS FOR ONE (1) 2.7MM TI VA LOCKING SCREW 14MM. THIS IS REPORT 2 OF 7 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1294336 2.7MM TI VA LCKNG SCR SLF-TPNG WITH T8 STARDRIVE RECESS 14MM SCREW, FIXATION, BONE HWC OBERDORF SYNTHES PRODUKTIONS GMBH 4L50948 07611819425231

    Patients

    Seq Age Sex Outcome Treatment
    1