BEUDAMED
    FDA Adverse Event Injury Summary report: N

    2.4MM TI VA LOCKING SCREW STARDRIVE 20MM-STERILE

    MDR report key: 7201240 · Received January 17, 2018

    Report

    Report Number
    8030965-2018-50436
    Event Type
    Injury
    Date Received
    January 17, 2018
    Report Date
    December 21, 2017
    Manufacturer
    OBERDORF SYNTHES PRODUKTIONS GMBH
    Product Code
    HRS
    UDI-DI
    07611819980662
    PMA / PMN Number
    K102694
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL NARRATIVE: UPDATED CONCOMITANT DEVICES. DEVICE HISTORY RECORDS REVIEW WAS COMPLETED FOR PART# 04.210.120S, LOT# L298950. MANUFACTURING LOCATION: (B)(4), RELEASE TO WAREHOUSE DATE: FEB 09, 2017, EXPIRY DATE: JAN 01, 2027. NON-STERILE PART# 04.210.120, LOT# H201755, MANUFACTURING LOCATION: (B)(4), MANUFACTURING DATE: JAN 12, 2017. NO NON- CONFORMANCE REPORTS WERE GENERATED DURING PRODUCTION. REVIEW OF THE DEVICE HISTORY RECORDS SHOWED THAT THERE WERE NO ISSUES DURING THE MANUFACTURE OF THE PRODUCT THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. COMPONENTS REVIEWED: RAW MATERIAL PART 21015, LOT 9955088 RECEIVED FROM SUPPLIER PERRYMAN COMPANY. CERTIFICATE OF TEST FOR TITANIUM INGOT RECEIVED FROM PERRYMAN MEETS SPECIFICATION. RAW MATERIAL RECEIVING/PUTAWAY CHECKLIST MET REQUIREMENTS. INSPECTION SHEET FOR INCOMING FINAL INSPECTION MET INSPECTION ACCEPTANCE CRITERIA. CERTIFICATE OF COMPLIANCE RECEIVED FROM MARK TWO ENGINEERING. INC. MEET SPECIFICATION. DEVICE HISTORY RECORDS REVIEW WAS COMPLETED FOR PART# 04.210.120S, LOT# L467963. MANUFACTURING LOCATION: (B)(4), RELEASE TO WAREHOUSE DATE: JUN 28, 2017, EXPIRY DATE: JUN 01, 2027. NON-STERILE PART# 04.210.120, LOT# H355717, MANUFACTURING LOCATION: (B)(4), MANUFACTURING DATE: MAY 17, 2017. NO NON- CONFORMANCE REPORTS WERE GENERATED DURING PRODUCTION. REVIEW OF THE DEVICE HISTORY RECORDS SHOWED THAT THERE WERE NO ISSUES DURING THE MANUFACTURE OF THE PRODUCT THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. COMPONENTS REVIEWED: RAW MATERIAL PART 04.211.020.999 2.8MM TI SCREW BLANK 20MM. BP55, LOT H346213 LOT WAS RELEASE TO BP55 ON 13-APR-2017. INSPECTION SHEET FOR IN-PROCESS DIMENSIONAL MET SPECIFICATION. INSPECTION SHEET FOR FINAL INSPECTION, MILL THREADS, TURN/THREAD HEAD, FLUTE FINAL INSPECTION MET INSPECTION ACCEPTANCE CRITERIA. DEVICE HISTORY RECORDS REVIEW WAS COMPLETED FOR PART# 04.210.120S, LOT# L477201. MANUFACTURING LOCATION: (B)(4), RELEASE TO WAREHOUSE DATE: JUL 04, 2017, EXPIRY DATE: JUN 01, 2027. NON-STERILE PART# 04.210.120, LOT# H330598, MANUFACTURING LOCATION: (B)(4), MANUFACTURING DATE: APR 11, 2017. NO NON- CONFORMANCE REPORTS WERE GENERATED DURING PRODUCTION. REVIEW OF THE DEVICE HISTORY RECORDS SHOWED THAT THERE WERE NO ISSUES DURING THE MANUFACTURE OF THE PRODUCT THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. COMPONENTS REVIEWED: RAW MATERIAL PART 04.211.020.999 2.8MM TI SCREW BLANK 20MM. BP55, LOT H312058. LOT WAS RELEASE TO BP55 ON 07-MAR-2017. INSPECTION SHEET FOR IN-PROCESS DIMENSIONAL MET SPECIFICATION. INSPECTION SHEET FOR FINAL INSPECTION, MILL THREADS, TURN/THREAD HEAD, FLUTE FINAL INSPECTION MET INSPECTION ACCEPTANCE CRITERIA. PRODUCT DEVELOPMENT INVESTIGATION WAS COMPLETED. TWO BROKE SCREWS WERE RETURNED. BOTH SCREWS WERE BROKEN JUST BELOW THE HEAD OF THE SCREW. THE SCREWS WERE DAMAGED AT THE BREAK POINT AND ALONG THE HEAD/SHAFT THREADS. THE MATERIAL WAS CHECKED WITH A NITON XRAY ANALYZER GUN AND WAS CONFIRMED TO BE THE CORRECT MATERIAL TYPE (TIALNB). THE THREAD MAJOR DIAMETER, THREAD MINOR DIAMETER, THREAD PROFILE, HEAD PROFILE AND HEAD THREAD PROFILE COULD NOT BE CHECKED DUE TO DAMAGE. SINCE THE FEATURES RELEVANT TO THE COMPLAINT CONDITION COULD NOT BE EVALUATED IT IS UNKNOWN IF THE CAUSE OF THE COMPLAINT CONDITION IS A RESULT OF THE MANUFACTURING PROCESS. THEREFORE, COMPLAINT IS NOT CONFIRMED FROM A MANUFACTURING STANDPOINT. 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

    CONCOMITANT DEVICES REPORTED: 2.4MM TI VA-LCP 2-CLMN VLR DST RAD PLATE (PART # 04.111.731S, LOT # L096056, QUANTITY 1), 2.4MM TI VA LOCKING SCREW STARDRIVE 12MM-STERILE (PART # 04.210.112S, LOT # L448234, QUANTITY 1), 2.4MM TI VA LOCKING SCREW STARDRIVE 14MM-STERILE (PART # 04.210.114S, LOT #L326359, QUANTITY 3), 2.4MM TI VA LOCKING SCREW STARDRIVE 16MM-STERILE (PART # 04.210.116S VA, LOT # L550722, QUANTITY 1), 2.4MM TI VA LOCKING SCREW STARDRIVE 16MM-STERILE (PART # 04.210.116S, LOT # L552825, QUANTITY 1), 2.7MM TI CORTEX SCREW SLF-TPNG WITH T8 STARDRIVE RECESS 16MM (PART # 402.876S, LOT #L334900, QUANTITY 1), VA LOCKSCR Ø2.4 SELF-TAP L20 TAN (PART #04.210.120S, LOT# L298950, L46796 OR L477201, QUANTITY 2).

    Additional Manufacturer Narrative · 1

    PATIENT¿S IDENTIFIER AND WEIGHT ARE UNKNOWN. DATE OF POSTOPERATIVE SCREW BREAKAGE IS UNKNOWN. (LOT NUMBER): THREE (3) SCREWS, ALL WITH PART NUMBER 04.210.120S AND LOT NUMBERS L298950, L467963, L477201 WERE REPORTED; HOWEVER, IT IS UNKNOWN OUT OF THESE THREE SCREWS, WHICH SCREW IS BROKEN. THE SUBJECT DEVICE HAS BEEN RECEIVED AND THE PRODUCT EVALUATION IS IN PROGRESS. NO CONCLUSION CAN BE DRAWN. 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 A PATIENT UNDERWENT THE INITIAL SURGERY FOR DISTAL RADIUS FRACTURE ON (B)(6) 2017 AND WAS IMPLANTED WITH THE VARIABLE ANGLE LOCKING COMPRESSION PLATE (VA-LCP). THE SURGERY WAS COMPLETED SUCCESSFULLY. AFTER THE SURGERY, DURING THE PATIENT¿S REHABILITATION, IT WAS FOUND THAT THE TWO SCREWS HAD BEEN BROKEN. ONE SCREW AT DISTAL END WAS BROKEN AND ANOTHER ONE IN THE MIDDLE WAS BROKEN. ON (B)(6) 2017, RE-OPERATION WAS PERFORMED TO REMOVE ALL IMPLANTS IN USE AND APPLY A PLASTER CAST FOR FIXATION. THE REMOVAL SURGERY WAS SUCCESSFULLY COMPLETED WITHOUT ANY EXTENSION. CONCOMITANT DEVICES REPORTED: 2.4 MM TI VA-LCP 2-CLMN VLR DST RAD PLATE (PART # 04.111.731S, LOT # L096056, QUANTITY 1), 2.4 MM TI VA LOCKING SCREW STARDRIVE 12 MM-STERILE (PART # 04.210.112S, LOT # L448234, QUANTITY 1), 2.4 MM TI VA LOCKING SCREW STARDRIVE 14 MM-STERILE (PART # 04.210.114S, LOT #L326359, QUANTITY 1), 2.4 MM TI VA LOCKING SCREW STARDRIVE 16 MM-STERILE (PART # 04.210.116S VA, LOT # L550722, QUANTITY 1), 2.4 MM TI VA LOCKING SCREW STARDRIVE 16 MM-STERILE (PART # 04.210.116S, LOT # L552825, QUANTITY 1), 2.7 MM TI CORTEX SCREW SLF-TPNG WITH T8 STARDRIVE RECESS 16 MM (PART # 402.876S, LOT #L334900, QUANTITY 1). THIS REPORT IS FOR ONE (1) BROKEN 2.4 MM TI VA LOCKING SCREW STARDRIVE 20 MM-STERILE. THIS IS REPORT 2 OF 2 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    44724 2.4MM TI VA LOCKING SCREW STARDRIVE 20MM-STERILE PLATE,FIXATION,BONE HRS OBERDORF SYNTHES PRODUKTIONS GMBH 07611819980662

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Required Intervention