BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    2.7MM TI VA LCKNG SCR SLF-TPNG WITH T8 STARDRIVE RECESS 18MM

    MDR report key: 7234217 · Received February 1, 2018

    Report

    Report Number
    8030965-2018-50780
    Event Type
    Malfunction
    Date Received
    February 1, 2018
    Date of Event
    January 11, 2018
    Report Date
    January 11, 2018
    Manufacturer
    OBERDORF : SYNTHES PRODUKTIONS GMBH
    Product Code
    HWC
    UDI-DI
    07611819425255
    PMA / PMN Number
    K103243
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL NARRATIVE: A DEVICE HISTORY RECORD REVIEW WAS PERFORMED FOR THE SUBJECT DEVICE PLEASE NOTE, THIS DHR REVIEW IS FOR STERILIZATION PROCEDURE ONLY: PART NO.: 04.211.018S LOT NO.: L076454 MANUFACTURING LOCATION: (B)(4) SUPPLIER: (B)(4) RELEASE TO WAREHOUSE DATE: 26.JUL.2016 EXPIRY DATE: 01.JUL.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 04.211.018 / H137378 WAS MANUFACTURED IN US, (B)(4). MANUFACTURING LOCATION: (B)(4). MANUFACTURING DATE: 06-JUL-2016 PART #: 04.211.018, LOT#: H137378 (NON-STERILE) - 2.7MM TI VA LCKNG SCR SLF-TPNG WITH T8 STARDRIVER RECESS 18MM. QTY: (B)(4). COMPONENTS: 04.211.018.999, 2.8MM TI SCREW BLANK 18MM, LOT H041428 LOT WAS RELEASE TO BP55 ON 23-JUN-2016. INSPECTION SHEET- MILL SHAFT THREADS, TURN/THREAD HEAD, FLUTE FINAL INSPECTION MEET INSPECTION ACCEPTANCE CRITERIA. NR WAS CREATED FOR PART 04.211.018.999 ON 03-MAY-2016 FOR 4/18 PARTS WERE FOUND OUT OF SPECIFICATION. PARTS WERE REWORKED FOR TAPER DEPTH SHALLOW. 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. A PRODUCT DEVELOPMENT INVESTIGATION WAS PERFORMED FOR THE SUBJECT DEVICE. THE EVALUATION OF THE RECEIVED LOCKING SCREW HAS SHOWN THAT THE THREAD FLANKS AT THE LOCKING HEAD ARE COMPLETELY FLATTENED. THEREFORE, THIS COMPLAINT IS CONFIRMED AS A LOCKING OF THE SCREW IS IMPOSSIBLE IN THIS CONDITION. THE EVALUATION HAS ALSO SHOWN THAT THE LAST TWO THREAD FLANKS OF THE SHAFT ARE ALSO TOTALLY FLATTENED, WHILE THE OTHER THREAD FLANKS ARE PARTIALLY FLATTENED. DUE TO THESE DAMAGES THE RELEVANT DIMENSIONS CANNOT BE VERIFIED ANYMORE. THE ANODIZED LAYER IS WORN AWAY AT ALL DAMAGES, WHICH CLEARLY SHOWS THAT THEY WERE CAUSED POST-MANUFACTURING. THE REVIEW OF THE MANUFACTURING DOCUMENTS HAS SHOWN THAT THIS SCREW WAS MANUFACTURED WITH A LOT SIZE OF (B)(4) PIECES ACCORDING TO THE SPECIFICATION IN JULY 2016. WE ARE NOT AWARE OF ANY OTHER COMPLAINT FOR THIS ARTICLE- AND LOT NUMBER COMBINATION (NEITHER FOR THE STERILE LOT L076454 NOR THE UNSTERILE LOT H137378). BASED ON THESE FINDINGS A MANUFACTURING RELATED ISSUE CAN BE EXCLUDED. AS STATED ABOVE, THE LAST TWO THREAD FLANKS AT THE SHAFT ARE COMPLETELY FLATTENED, THIS IS AN INDICATION FOR A STRONG METALLIC CONTACT WITH THE PLATE, MOST LIKELY BY AN EXCESSIVE INSERTION ANGLE OF THE SCREW. IT CAN BE ASSUME THAT THE SAME CONTACT DID ALSO DAMAGE THE THREAD FLANKS AT THE HEAD AND MADE FINALLY THE LOCKING OF THE SCREW IMPOSSIBLE. 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. CLARIFICATION OF EVENT DESCRIPTION/CONCOMITANT DEVICES. DATE RETURNED TO MANUFACTURER. 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

    DEVICE REPORT FROM SYNTHES EUROPE REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED DURING A PROCEDURE FOR THE RIGHT FIRST METATARSAL BONE FRACTURE ON (B)(6) 2018, THE VARIABLE ANGLE (VA) LOCKING SCREW COULD NOT BE TIGHTENED. SURGEON STATED THE PATIENT¿S INFERIOR BONE QUALITY, EVEN THE TEMPORARY BONE FIXATION WITH KIRSCHNER WIRE (K-WIRE) WAS NOT EFFECTIVE ENOUGH FOR THE SCREW INSERTION WITH THE DESIRED ANGLE. SURGERY WAS UNSUCCESSFULLY COMPLETED WITH A 20 MINUTE DELAY, SURGEON ABORTED THE PROCEDURE. PATIENT STATUS WAS REPORTED AS OKAY. CONCOMITANT DEVICES REPORTED: K-WIRE (PART NUMBER UNKNOWN, LOT NUMBER UNKNOWN, QUANTITY 1), INSERTION INSTRUMENT (PART NUMBER UNKNOWN, LOT NUMBER UNKNOWN, QUANTITY 1)

    Additional Manufacturer Narrative · 1

    ADDITIONAL PROCODES: HRS. THE DEVICE WAS REMOVED FROM THE PATIENT INTRAOPERATIVELY. COMPLAINANT PART HAS BEEN RECEIVED, HOWEVER, PRODUCT INVESTIGATION IS NOT YET COMPLETED; NO CONCLUSION COULD 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

    THE SCREWS WERE USED IN SURGERY FOR THE RIGHT FIRST METATARSAL BONE FRACTURE ON (B)(6) 2018. VA LOCK SCREW IN QUESTION COULD NOT BE TIGHTENED. THE SURGEON COMPLETED IT WITH A 20-MINUTE DELAY. THERE WAS NO ADVERSE CONSEQUENCE TO THE PATIENT. THE SURGEON¿S COMMENTS: THE SCREW INSERTION ANGLE MAY HAVE NOT BEEN STABLE EVEN WITH THE HELP OF TENTATIVE BONE FIXATION WITH K-WIRE. THIS COMPLAINT INVOLVES 2 DEVICES. CONCOMITANT PARTS: -K-WIRE (PART# UNKNOWN / LOT# UNKNOWN / QUANTITY 1). -INSERTION ANGLE (PART# UNKNOWN / LOT# UNKNOWN / QUANTITY 1). THIS COMPLAINT IS FOR ONE (1) SCREW. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    78289 2.7MM TI VA LCKNG SCR SLF-TPNG WITH T8 STARDRIVE RECESS 18MM SCREW,FIXATION,BONE HWC OBERDORF : SYNTHES PRODUKTIONS GMBH L076454 07611819425255

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR