BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPEED COMPRESSION IMPLANT KIT 25X20X20MM

    MDR report key: 9141279 · Received October 1, 2019

    Report

    Report Number
    8030965-2019-68896
    Event Type
    Malfunction
    Date Received
    October 1, 2019
    Report Date
    September 5, 2019
    Manufacturer
    OBERDORF SYNTHES PRODUKTIONS GMBH
    Product Code
    JDR
    UDI-DI
    00810633020234
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    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. THE COMPLAINT CONDITION COULD BE CONFIRMED ACCORDING THE RECEIVED PICTURES. PRODUCT WAS NOT RETURNED. BASED ON THE INFORMATION AVAILABLE, IT HAS BEEN DETERMINED THAT NO CORRECTIVE AND 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 HISTORY PART NUMBER: SE-2520, BME LOT NUMBER: BSE170540, MANUFACTURING DATE OR RELEASE TO WAREHOUSE DATE: 16AUG2017, PLACE OF MANUFACTURE: BIOMEDICAL ENTERPRISES, SAN ANTONIO, TX, LOT EXPIRATION DATE: 23MAR2022. DHR REVIEW: A REVIEW OF THE DEVICE HISTORY RECORD REVEALED NO COMPLAINT RELATED ANOMALIES. THE DEVICE HISTORY RECORD SHOWS THIS LOT OF SE-2520 WAS PROCESSED THROUGH A DEVIATED PROCESS WITH NO NONCONFORMITIES NOTED. DEVIATIONS INCLUDE PD# 1137 FOR USE OF A STREAMLINED LABELING PROCESS AS A TEST FOR PROCESS IMPROVEMENTS, PD# 1132 FOR USE OF DOWN-REV IFUS IN THE KIT TO EXHAUST INVENTORY BEFORE SWITCHING, & PD# 1150 FOR PRODUCT OVER-LABELING (ALL DEVIATIONS HOUSED IN QCBD). THE IDENTIFIED PROCESS DEVIATIONS ARE NOT RELEVANT TO THE COMPLAINT CONDITION AS LOT WAS 100% VISUALLY INSPECTED PER INSPECTION REPORT # 172279 PRIOR TO RELEASE WITH NO ABNORMALITIES IDENTIFIED. 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. THE REVIEW OF THE RAW MATERIAL DEVICE HISTORY RECORD USED IN MANUFACTURE OF LOT# BSE170540 REVEALED ONE NONCONFORMANCE (NCMR # 2631 HOUSED IN QCBD) TO BE ASSOCIATED TO RAW MATERIAL LOT 1607120188. THE NCMR WAS GENERATED DUE TO PRESENCE OF EDM WIRE MARK COSMETIC DEFECTS ON QTY 3 / 152 IMPLANTS. THE 3 NC ITEMS WERE SCRAPPED AND THE REMAINING CONFORMING ITEMS WERE RELEASED FROM HOLD. THE NONCONFORMANCE IS NOT RELEVANT TO THE COMPLAINT BECAUSE THE DEFECT WAS COSMETIC IN NATURE ALL ITEMS EXHIBITING THE DEFECT WERE REMOVED AT TIME OF DETECTION. THIS RAW MATERIAL LOT MET ALL DIMENSIONAL AND VISUAL CRITERIA AT THE TIME OF RELEASE WITH NO ISSUES DOCUMENTED 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 · 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. THE DEVICE WAS RECEIVED, THE INVESTIGATION IS IN PROGRESS, NO CONCLUSION COULD BE DRAWN AT THE TIME OF FILING 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

    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. PART NUMBER: SE-2520 BME LOT NUMBER: BSE170540. MANUFACTURING DATE OR RELEASE TO WAREHOUSE DATE: 16AUG2017. PLACE OF MANUFACTURE: BIOMEDICAL ENTERPRISES, SAN ANTONIO, TX. LOT EXPIRATION DATE: 23MAR2022. DHR REVIEW: A REVIEW OF THE DEVICE HISTORY RECORD REVEALED NO COMPLAINT RELATED ANOMALIES. THE DEVICE HISTORY RECORD SHOWS THIS LOT OF SE-2520 WAS PROCESSED THROUGH A DEVIATED PROCESS WITH NO NONCONFORMITIES NOTED. DEVIATIONS FOR USE OF A STREAMLINED LABELING PROCESS AS A TEST FOR PROCESS IMPROVEMENTS, FOR USE OF DOWN-REV IFUS IN THE KIT TO EXHAUST INVENTORY BEFORE SWITCHING, & FOR PRODUCT OVER-LABELING (ALL DEVIATIONS HOUSED IN QCBD). THE IDENTIFIED PROCESS DEVIATIONS ARE NOT RELEVANT TO THE COMPLAINT CONDITION AS LOT WAS 100% VISUALLY INSPECTED PER INSPECTION REPORT PRIOR TO RELEASE WITH NO ABNORMALITIES IDENTIFIED. 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. THE REVIEW OF THE RAW MATERIAL DEVICE HISTORY RECORD USED IN MANUFACTURE OF LOT# BSE170540 REVEALED ONE NONCONFORMANCE TO BE ASSOCIATED TO RAW MATERIAL LOT 1607120188. THE NCMR WAS GENERATED DUE TO PRESENCE OF EDM WIRE MARK COSMETIC DEFECTS ON QTY 3 / 152 IMPLANTS. THE 3 NC ITEMS WERE SCRAPPED AND THE REMAINING CONFORMING ITEMS WERE RELEASED FROM HOLD. THE NONCONFORMANCE IS NOT RELEVANT TO THE COMPLAINT BECAUSE THE DEFECT WAS COSMETIC IN NATURE ALL ITEMS EXHIBITING THE DEFECT WERE REMOVED AT TIME OF DETECTION. THIS RAW MATERIAL LOT MET ALL DIMENSIONAL AND VISUAL CRITERIA AT THE TIME OF RELEASE WITH NO ISSUES DOCUMENTED THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. THIS NONCONFORMANCE IS NOT RELEVANT TO THE COMPLAINT AS ALL VISUALLY NC ITEMS WERE REMOVED AT TIME OF DETECTION. A PICTURE OF THE COMPLAINT PART WAS FORWARDED TO BME FOR EVALUATION. HERE THE STATEMENT. DEVICE WAS NOT RETURNED HOWEVER PHOTOS OF COMPLAINT DEVICE ATTACHED TO THE PRODUCT COMPLAINT RECORD WERE REVIEWED. VISUAL INSPECTION OF THE PHOTOS SHOWED THAT THE IMPLANT WAS DEPLOYED FROM ITS INSERTER AND THAT THE RELEASE BUTTON WAS ACTUATED IN THE LOWERED POSITION, CONFIRMING THE COMPLAINT DESCRIPTION (REFER TO PICTURES ATTACHED TO COMPLAINT). IT WAS ALSO OBSERVED THERE WAS A CREASE ON THE DEVICE BOX AND SMALL SCRATCHES ON THE INNER TRAY NEAR THE LOCATION OF THE RELEASE BUTTON INDICATING THE RELEASE BUTTON MAY HAD BEEN ACTUATED THROUGH THE PACKAGING DURING STORAGE OR TRANSIT/HANDLING. VISUAL INSPECTION OF COMPLAINT PHOTOS WAS PERFORMED ON 21-NOV-2019 BY C. SCHMITZ. FUNCTIONAL TESTING WAS NOT PERFORMED AS THE DEVICE WAS NOT PHYSICALLY RETURNED THOUGH VISUALLY THE DEVICE CAN BE CONFIRMED TO NOT FUNCTION APPROPRIATELY DUE TO A DEPLOYED IMPLANT. DIMENSIONAL INSPECTION WAS NOT PERFORMED AS THE DEVICE WAS NOT PHYSICALLY RETURNED AND COULD NOT BE DIMENSIONALLY INSPECTED. DOCUMENTATION REVIEW ON 21-NOV-2019 BY C. SCHMITZ IDENTIFIED THAT AN UPDATE TO THE PACKAGING CONFIGURATION FOR SPEED IMPLANTS WAS RELEASED ON AUGUST 23, 2018 (AFTER LOT# BSE170540 MFG DATE) VIA CHANGE ORDER AND THAT THE CURRENT SPEED IMPLANT KIT PACKAGING PROCEDURE INSTRUCTS THE IMPLANT KIT BE PACKAGED WITH THE RELEASE BUTTON FACING DOWN, INSTEAD OF FACING UP, TO REDUCE THE RISK OF ACTUATION OF THE RELEASE BUTTON THROUGH THE PACKAGING TRAY. BASED ON THE INVESTIGATION CONDUCTED IT HAS BEEN DETERMINED THAT THE MOST PROBABLE ROOT CAUSE FOR THIS TYPE OF COMPLAINT IS THE PACKAGING DESIGN, WITH TRANSIT/HANDLING BEING A CONTRIBUTING FACTOR. NO MANUFACTURING DEFECTS OR DEFICIENCIES WERE IDENTIFIED AND/OR CONFIRMED, THEREFORE REVIEW TO THE SPECIFIC PRM AND PRM LINE IS NOT REQUIRED. IT THE POTENTIAL IMPACT OF THE DESIGN TO THE COMPLAINT HAS BEEN PARTIALLY ADDRESSED VIA CHANGE ORDER AND ADDITIONAL DESIGN CHANGES ARE BEING ADDRESSED UNDER A CAPA. NO FURTHER CORRECTIVE ACTION IS DEEMED NECESSARY AT THIS TIME. 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

    INITIAL REPORTER IS SYNTHES SALES REPRESENTATIVE. DEVICE IS NOT DISTRIBUTED IN THE UNITED STATES, BUT IS SIMILAR TO DEVICE MARKETED IN THE USA. 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 REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT ON AN UNKNOWN DATE, WHEN CHECKING THE ORTHOKIT CCI BMW-SPEED SE-2520, A PACKAGED AND STILL UNOPENED CCI IMPLANT WAS DAMAGED. IT WAS THEN REMOVED FROM THE ORTHOKIT. THE CCI IMPLANT WAS NO LONGER PLACED ON THE INSERTION INSTRUMENT IN ITS UNOPENED PACKAGING AND WAS TRIGGERED AND NO LONGER READY FOR USE. THIS REPORT IS FOR ONE (1) SPEED COMPRESSION IMPLANT KIT 25 X 20 X 20 MM. THIS IS REPORT 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    934827 SPEED COMPRESSION IMPLANT KIT 25X20X20MM STAPLE,FIXATION,BONE JDR OBERDORF SYNTHES PRODUKTIONS GMBH SE-2520 BSE170540 00810633020234

    Patients

    Seq Age Sex Outcome Treatment
    1