BEUDAMED
    FDA Adverse Event Injury Summary report: N

    4.5MM CORTEX SCREW SELF-TAPPING 38MM

    MDR report key: 9622677 · Received January 23, 2020

    Report

    Report Number
    8030965-2020-00564
    Event Type
    Injury
    Date Received
    January 23, 2020
    Report Date
    January 20, 2020
    Manufacturer
    OBERDORF SYNTHES PRODUKTIONS GMBH
    Product Code
    HWC
    UDI-DI
    07611819004658
    PMA / PMN Number
    K112583
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NZ
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    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. 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

    PRODUCT COMPLAINT # (B)(4). 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. E1: REPORTERS STATE: (B)(6). H3, H4, H6: A REVIEW OF THE DEVICE HISTORY RECORD. DEVICE HISTORY LOT PART: 214.838, LOT: L511971, MANUFACTURING SITE: MEZZOVICO, RELEASE TO WAREHOUSE DATE: 28.JUL.2017. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE LOT NUMBER, AND NO NON-CONFORMANCES WERE IDENTIFIED. THE REVIEW HAS SHOWN THAT THIS SCREW WAS MADE OUT OF BLANK 214.038.999 WITH LOT H378114, THEREFORE AN ADDITIONAL DHR REVIEW ACTIVITY WAS ASSIGNED TO MONUMENT: MANUFACTURING LOCATION: MONUMENT MANUFACTURING DATE: 29-JUN-2017 PART NUMBER: 214.038.999, 4.6MM SCREW BLANK 38MM 04.5 CORTEX SCREW W/3.5 HEX LOT NUMBER: H378114 (NON-STERILE) LOT QUANTITY: 959 WORK ORDER TRAVELER MET ALL INSPECTION ACCEPTANCE CRITERIA. COMPONENT PART(S) REVIEWED: PART NUMBER: 13008, 316LC*RI4.58 LOT NUMBER: H210706 LOT QUANTITY: 3,041 LBS. CERTIFICATE OF TESTS SUPPLIED BY CARPENTER DATED 28-SEP-2016 WAS REVIEWED AND DETERMINED TO BE CONFORMING. LOT SUMMARY REPORT DATED 10-OCT-2016 MET ALL INSPECTION ACCEPTANCE CRITERIA. RAW MATERIAL RECEIVING/PUTAWAY CHECKLIST MET ALL INSPECTION ACCEPTANCE CRITERIA. THIS LOT MET ALL DIMENSIONAL AND VISUAL CRITERIA AT THE TIME OF RELEASE WITH NO ISSUES DOCUMENTED DURING THE MANUFACTURE THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. DEVICE HISTORY BATCH NULL, DEVICE HISTORY REVIEW 18-FEB-2020: DHR REVIEWED. THIS LOT MET ALL DIMENSIONAL AND VISUAL CRITERIA AT THE TIME OF RELEASE WITH NO ISSUES DOCUMENTED DURING THE MANUFACTURE THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. H3, H6: INVESTIGATION SUMMARY INVESTIGATION SITE: CQ ZUCHWIL. SELECTED FLOW: DAMAGED: VISUAL / EXAMPLES: DEFORMED/BENT/CRACKED/BROKEN. VISUAL INSPECTION: THE CORTEX SCREW Ø 4.5MM, SELF-TAPP., L 38MM IS BROKEN APART AT THE SHAFT. THE FRAGMENT WITH THE TIP WITH A LENGTH OF ABOUT 12MM WAS NOT RETURNED FOR EVALUATION OTHERWISE IS THE SCREW IN A GOOD CONDITION WITH SLIGHT WEAR MARKS AT THE SHAFT AND THE HEAD. DIMENSIONAL INSPECTION: CHECKED DIMENSIONS WITH CALIPER. DRAWING SPECIFICATION REVIEW: DRAWINGS 214.814 WERE REVIEWED TO VERIFY THE RELEVANT DIMENSIONS AND THE MATERIAL SPECIFICATION OF THE CORTEX SCREW. THE REVIEW OF THE MANUFACTURING DOCUMENTS HAS SHOWN THAT WITH STAINLESS STEEL ACCORDING TO NORM ISO 5832-1 FOR SURGICAL IMPLANTS THE CORRECT MATERIAL WAS USED. INVESTIGATION CONCLUSION: THE COMPLAINT IS CONFIRMED AS THE RECEIVED CORTEX SCREW IS BROKEN. DURING THE PERFORMED EVALUATION NO MANUFACTURING RELATED ISSUE COULD BE DETECTED, THE SCREW WAS MANUFACTURED ACCORDING TO THE SPECIFICATION. THE EXACT CAUSE OF THIS SCREW BREAKAGE CANNOT BE DEFINED AS THERE WAS NO INFORMATION PROVIDED IF THE SCREW BROKE IN SITU OR DURING EXTRACTION. BASED ON THE PROVIDED INFORMATION WE CAN ONLY ASSUME THAT A COMPLICATION DURING THE HEALING PROCESS, LIKE THE MENTIONED METABOLIC BONE DISEASE WITH THE RELATED NON UNION, DID LEAD A FATIGUE FAILURE OF THE SCREW, EITHER IN SITU OR DURING EXTRACTION AS THE SCREW WAS WEAKENED. 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. ADDITIONAL MONITORING FOR ANY POTENTIAL SAFETY SIGNALS WILL BE CONDUCTED THROUGH COMPLAINT TRENDING AND OTHER POST MARKET SAFETY SURVEILLANCE ACTIVITIES. 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 DEVICE REPORTED: 5.0MM LOCKING SCREWSELF-TAPPING 80MM (PRODUCT CODE: 213.380, LOT #: L528658, QUANTITY: 1), 5.0MM LOCKING SCREW SELF-TAPPING 75MM (PRODUCT CODE: 213.375, LOT #: 7918910, QUANTITY: 1), 5.0MM LOCKING SCREW SELF-TAPPING 75MM (PRODUCT CODE: 213.375, LOT #: L108563, QUANTITY: 1), 5.0MM LOCKING SCREW SELF-TAPPING 65MM (PRODUCT CODE: 213.365, LOT #: 2161126, QUANTITY: 2), 5.0MM LOCKING SCREW SELF-TAPPING 55MM (PRODUCT CODE: 213.355, LOT #: 9875351, QUANTITY: 1), 5.0MM LOCKING SCREW SELF-TAPPING 40MM (PRODUCT CODE: 213.340, LOT #: L629099, QUANTITY: 1), 4.5MM CORTEX SCREW SELF-TAPPING 36MM (PRODUCT CODE: 214.836, LOT #: 9401022, QUANTITY: 1).

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS RECEIVED, THE INVESTIGATION COULD NOT BE COMPLETED, AND NO CONCLUSION COULD BE DRAWN, AS PRODUCT IS ENTERING THE COMPLAINT SYSTEM. (B)(4). 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 AN UNKNOWN DATE THE PATIENT PRESENTED WITH ANOTHER BROKEN LOCKING COMPRESSION PLATE (LCP) DISTAL FEMUR PLATE. IN THE 13-HOLE RIGHT LCP DF PLATE THERE WAS AN INCOMPLETE BREAK IN THE DISTAL THIRD OF THE SHAFT WITH A PLASTIC DEFORMATION. THE PATIENT IS THOUGHT TO HAVE A METABOLIC BONE DISEASE WHICH LEAD TO A NONUNION. THE REVISION SURGERY WAS DONE IN (B)(6) 2019. X-RAYS, ADDITIONAL PLATES AND BONE GRAFTING WERE REQUIRED. CONCOMITANT DEVICES: 5.0MM LOCKING SCREWSELF-TAPPING 80MM (PRODUCT CODE: 213.380, LOT #: L528658, QUANTITY: 1), 5.0MM LOCKING SCREW SELF-TAPPING 75MM (PRODUCT CODE: 213.375, LOT #: 7918910, QUANTITY: 1), 5.0MM LOCKING SCREW SELF-TAPPING 75MM (PRODUCT CODE: 213.375, LOT #: L108563, QUANTITY: 1), 5.0MM LOCKING SCREW SELF-TAPPING 65MM (PRODUCT CODE: 213.365, LOT #: 2161126, QUANTITY: 2), 5.0MM LOCKING SCREW SELF-TAPPING 55MM (PRODUCT CODE: 213.355, LOT #: 9875351, QUANTITY: 1), 5.0MM LOCKING SCREW SELF-TAPPING 40MM (PRODUCT CODE: 213.340, LOT #: L629099, QUANTITY: 1), 4.5MM CORTEX SCREW SELF-TAPPING 36MM (PRODUCT CODE: 214.836, LOT #: 9401022, QUANTITY: 1). THIS REPORT IS FOR ONE 4.5MM CORTEX SCREW SELF-TAPPING 38MM. THIS REPORT IS 4 OF 4 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    87018 4.5MM CORTEX SCREW SELF-TAPPING 38MM SCREW,FIXATION,BONE HWC OBERDORF SYNTHES PRODUKTIONS GMBH L511971 07611819004658

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention CORTSCR Ø4.5 SELF-TAP L36 SST| CORTSCR Ø4.5 SELF-TAP L36 SST| LOCKSCR Ø5 SELF-TAP L40 SST| LOCKSCR Ø5 SELF-TAP L40 SST| LOCKSCR Ø5 SELF-TAP L55 SST| LOCKSCR Ø5 SELF-TAP L55 SST| LOCKSCR Ø5 SELF-TAP L65 SST| LOCKSCR Ø5 SELF-TAP L65 SST| LOCKSCR Ø5 SELF-TAP L65 SST| LOCKSCR Ø5 SELF-TAP L65 SST| LOCKSCR Ø5 SELF-TAP L75 SST| LOCKSCR Ø5 SELF-TAP L75 SST| LOCKSCR Ø5 SELF-TAP L75 SST| LOCKSCR Ø5 SELF-TAP L75 SST| LOCKSCR Ø5 SELF-TAP L80 SST| LOCKSCR Ø5 SELF-TAP L80 SST| CORTSCR Ø4.5 SELF-TAP L36 SST| LOCKSCR Ø5 SELF-TAP L40 SST| LOCKSCR Ø5 SELF-TAP L55 SST| LOCKSCR Ø5 SELF-TAP L65 SST| LOCKSCR Ø5 SELF-TAP L65 SST| LOCKSCR Ø5 SELF-TAP L75 SST| LOCKSCR Ø5 SELF-TAP L75 SST| LOCKSCR Ø5 SELF-TAP L80 SST