BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    3.5MM TI LCP® RECONSTRUCTION PLATE 8 HOLES/112MM

    MDR report key: 7558096 · Received May 31, 2018

    Report

    Report Number
    8030965-2018-54065
    Event Type
    Malfunction
    Date Received
    May 31, 2018
    Date of Event
    May 11, 2018
    Report Date
    May 11, 2018
    Manufacturer
    OBERDORF SYNTHES PRODUKTIONS GMBH
    Product Code
    KTT
    UDI-DI
    07611819265943
    PMA / PMN Number
    K000684
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    HEALTH 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 HISTORY RECORDS REVIEW WAS COMPLETED FOR PART# 445.081S, LOT# 9093714. MANUFACTURING LOCATION: SELZACH, RELEASE TO WAREHOUSE DATE: AUG 11, 2014. NON-STERILE PART# 445.081, LOT# 8996414, MANUFACTURING LOCATION: RARON, RELEASE TO WAREHOUSE DATE: JUN 03, 2014. 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. PRODUCT DEVELOPMENT INVESTIGATION WAS COMPLETED. THE PLATE WAS CRACKED AT ONE SIDE OF THE SECOND LOCKING HOLE. THE PLATE WAS EXCESSIVELY BENT AT THE CRACKED ZONE. THERE WAS ANOTHER BENT IN THE MIDDLE OF THE PLATE. THERE WERE EXTREME MARKS OF A BENDING TOOL VISIBLE ALL OVER THE PLATE. CHECKED DIMENSIONS WITH CALIPER 3-01-19789. PLATE THICKNESS, SPECIFICATION 3MM +/-0.1 / MEASURED: 3.01MM = PASS, PLATE WIDTH - SPECIFICATION 10MM +0.1/-0.2 / MEASURED: 9.99MM = PASS. RAW MATERIAL CERTIFICATE WAS REVIEWED AND THE USED MATERIAL WAS ACCORDING TO NORM. THE INVESTIGATION HAS SHOWN THAT THE CAUSE OF COMPLAINED MALFUNCTION IS A USE RELATED POST-MANUFACTURING CAUSED DAMAGE AT THE DEVICE, THEREFORE NO DRAWING/SPECIFICATION REVIEW IS NEEDED. THE COMPLAINT IS CONFIRMED AS THE PLATE IS CRACKED AS COMPLAINED. THIS LOT OF (B)(4) PIECES WAS MANUFACTURED IN JUNE 2014 AND WE ARE NOT AWARE OF ANY OTHER COMPLAINT FOR THIS ARTICLE- AND LOT NUMBER COMBINATION (INCLUDING UNSTERILE LOT 8996414). BASED ON THAT AND THE INVESTIGATION FINDINGS A MANUFACTURING RELATED ISSUE CAN BE EXCLUDED. BASED ON THE APPEARANCE OF THE PLATE IT CAN BE ASSUMED THAT EXCESSIVE BENDING DID LEAD TO THE COMPLAINED CRACK. THE POSITION OF THE CRACK DOES SHOW THAT THE BEND WAS MADE AT THE LEVEL OF THE HOLE. THE BENDING TOOL MARKS ARE AN INDICATION THAT AN INCORRECT BENDING TOOL WAS USED AS SUCH SHARP MARKS WOULD NOT HAPPEN WITH A ROUNDED STANDARD BENDING TOOL. AS PER THE LCP LOCKING COMPRESSION PLATE SURGICAL TECHNIQUE, REVERSE BENDING OR USE OF THE INCORRECT INSTRUMENTATION FOR BENDING MAY WEAKEN THE PLATE AND LEAD TO PREMATURE PLATE FAILURE (E.G. BREAKAGE). DO NOT BEND THE PLATE BEYOND WHAT IS REQUIRED TO MATCH THE ANATOMY. DO NOT BEND THE PLATE AT THE LEVEL OF THE HOLES. 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 · 1

    PATIENT INFORMATION IS UNKNOWN. DEVICE MALFUNCTIONED INTRA-OPERATIVELY AND WAS NOT IMPLANTED / EXPLANTED. REPORTER EMAIL ADDRESS IS UNKNOWN. THE DEVICE WAS RECEIVED, THE INVESTIGATION COULD NOT BE COMPLETED, AND NO CONCLUSION COULD BE DRAWN, AS PRODUCT IS ENTERING THE COMPLAINT SYSTEM. A DEVICE HISTORY RECORDS REVIEW HAS BEEN REQUESTED. 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 AN ORIF (OPEN REDUCTION INTERNAL FIXATION) WAS APPLIED TO DISTAL FEMUR FRACTURES ON (B)(6) 2018. WHEN THE SURGEON WAS BENDING THE LCP (LOCKING COMPRESSION PLATE) RECONSTRUCTION PLATE, THE AREA(S) AROUND A SCREW HOLE CRACKED. HE COMPLETED THE SURGERY WITH A REPLACEMENT PLATE. THERE WAS NO ADVERSE CONSEQUENCE TO THE PATIENT. THIS REPORT IS FOR A 3.5MM TI LCP® RECONSTRUCTION PLATE 8 HOLES/112MM. THIS IS REPORT 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    401281 3.5MM TI LCP® RECONSTRUCTION PLATE 8 HOLES/112MM APPLIANCE, FIXATION, NAIL KTT OBERDORF SYNTHES PRODUKTIONS GMBH 9093714 07611819265943

    Patients

    Seq Age Sex Outcome Treatment
    1