BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CANN CONNECTING SCR F/PERCUTAN INSTRUMENTS FOR NAILS-EX

    MDR report key: 7196456 · Received January 16, 2018

    Report

    Report Number
    8030965-2018-50387
    Event Type
    Injury
    Date Received
    January 16, 2018
    Date of Event
    December 18, 2017
    Report Date
    December 19, 2017
    Manufacturer
    OBERDORF : SYNTHES PRODUKTIONS GMBH
    Product Code
    FZX
    UDI-DI
    07611819501706
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    DATE RETURNED TO MANUFACTURER. SUBJECT DEVICE HAS BEEN RECEIVED AND IS CURRENTLY IN THE EVALUATION PROCESS. 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 IS AN INSTRUMENT AND IS NOT IMPLANTED/EXPLANTED. COMPLAINANT PART IS EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION, BUT HAS YET TO BE RECEIVED. (B)(6). 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.

    Additional Manufacturer Narrative · 1

    CONCOMITANT DEVICES: INSERTION HANDLE (PART 03.010.440, LOT 170223-101, QUANTITY 1) IS NO LONGER A CONCOMITANT DEVICE. A DEVICE HISTORY RECORD REVIEW WAS PERFORMED FOR THE SUBJECT: PART NUMBER: 03.010.404, SYNTHES LOT NUMBER: U279896, SUPPLIER LOT NUMBER: N/A, RELEASE TO WAREHOUSE DATE: 28-NOV-2017, 07-DEC-2017, EXPIRATION DATE: N/A, SUPPLIER: (B)(4). NO NCRS WERE GENERATED DURING PRODUCTION. REVIEW OF THE DEVICE HISTORY RECORD SHOWED THAT THERE WERE NO ISSUES DURING THE MANUFACTURE OF THIS PRODUCT, AND ANY SUBCOMPONENTS, WHICH WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. A PRODUCT DEVELOPMENT INVESTIGATION WAS PERFORMED FOR THE SUBJECT DEVICE: DEVICE CONDITION: THE CONNECTING SCREW WAS RECEIVED WITH WORN THREADS AND TWO SMALL INDENTS IN THE THREADS; SEE ¿(B)(4), INVESTIGATION IMAGES¿ ATTACHED.(B)(4). STRIATION MARKS FROM USE WERE ALSO VISIBLE ON THE DISTAL PORTION OF THE SHAFT. THE COMPLAINT CONDITION IS CONFIRMED AS THE THREADS WHICH CONNECT WITH THE NAIL WERE RECEIVED DAMAGED. HOWEVER, THE CONDITION COULD NOT BE REPLICATED OR FUNCTIONALLY TESTED AS THE MATING NAIL WAS NOT RECEIVED. LOT NUMBER REVIEW: REVIEW OF THE DEVICE HISTORY RECORD SHOWED THAT THERE WERE NO ISSUES DURING THE MANUFACTURE OF THIS PRODUCT, AND ANY SUBCOMPONENTS, WHICH WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. THE LOT WENT THROUGH THE REQUIRED STEPS DURING THE INSPECTION AT THE TIME OF MANUFACTURING AND THE DHR RECORDS SHOWED NO ISSUES CONCERNING THE MATERIAL OR MATERIAL CONDITIONING. RELEASE TO WAREHOUSE DATE: 28-NOV-2017, 07-DEC-2017 DRAWING REVIEW: BASED ON THE DATE OF MANUFACTURE THE FOLLOWING DRAWINGS, REFLECTING THE CURRENT AND MANUFACTURED REVISION, WERE REVIEWED. CANNULATED CONNECTING SCREW: 03_010_404. THE DAMAGE TO THE THREADS IS VISUALLY CONFIRMED AND NOT APPLICABLE FOR DIMENSIONAL INSPECTION AS THE THREADS ARE ALREADY DAMAGED AND THIS DAMAGE WOULD INHIBIT GAGING. THE OUTER DIAMETER JUST PROXIMAL TO THE START OF THE THREADS MEASURED 6.81 WHICH IS WITHIN THE SPECIFICATION OF 6.8 +0.15/-0 PER 03_010_404 AND THE OUTER DIAMETER OF THE DISTAL PORTION OF THE MAIN SHAFT WAS FOUND TO MEASURE 8.00 MM WHICH IS WITHIN THE SPECIFICATION OF 8 MM +/- 0.03. THUS, THE OTHER MATING SURFACES WERE CONFIRMED TO BE WITHIN SPECIFICATION. (CALIPERS: CA102P). DURING THE INVESTIGATION NO PRODUCT DESIGN ISSUES OR DISCREPANCIES WERE OBSERVED THAT MAY HAVE CONTRIBUTED TO THE COMPLAINT CONDITION. NO DEFINITIVE ROOT CAUSE WAS ABLE TO BE DETERMINED AS CIRCUMSTANCES SURROUNDING THE EVENT ARE UNKNOWN. HOWEVER, THE DAMAGE TO THE THREADS HAS THE POTENTIAL TO HAVE CONTRIBUTED IN THE DIFFICULTY TO DISASSEMBLY THE DEVICES. ADDITIONALLY, THE DAMAGE OBSERVED ON THE MATING INSERTION HANDLE IS CONSISTENT WITH EXPOSURE TO SIGNIFICANT TORSIONAL FORCE AGAINST THE MATING NAIL. CONCLUSION: A DEVICE HISTORY RECORD (DHR) REVIEW, DEVICE INSPECTION, DRAWING REVIEW, COMPLAINT HISTORY REVIEW, AND RISK ASSESSMENT REVIEW WERE PERFORMED AS PART OF THIS INVESTIGATION. THE COMPLAINT CONDITION IS CONFIRMED AS THE THREADS OF THE CONNECTING SCREW ARE DAMAGED. THE DEVICE HISTORY RECORD SHOWED THAT THERE WERE NO ISSUES DURING THE MANUFACTURE OF THIS PRODUCT AND NO PRODUCT DESIGN ISSUES OR DISCREPANCIES WERE OBSERVED THAT MAY HAVE CONTRIBUTED TO THE COMPLAINT CONDITION. THUS, THERE IS NO INDICATION THAT A DESIGN OR MANUFACTURING ISSUE CONTRIBUTED TO THE COMPLAINT. THE RISK ASSESSMENT WAS FOUND TO ADEQUATELY ADDRESS THE COMPLAINT CONDITION. BASED ON THE INVESTIGATION FINDINGS, IT HAS BEEN DETERMINED THAT NO CORRECTIVE AND/OR PREVENTATIVE ACTION IS PROPOSED. 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 DURING SURGERY WHEN USING THE SUPRA PATELLA NAILING KIT, THE SURGEON WAS UNABLE TO DISCONNECT THE CONNECTING SCREW FROM THE NAIL. EVENTUALLY HE HAD TO GIVE UP ON REMOVING THE CONNECTING SCREW IN FEAR OF CAUSING MORE DAMAGE TO THE PATIENT. HE THEN HAD TO REMOVE THE LOCKING BOLTS THAT HE HAD INSERTED AND THEN REMOVE THE NAIL STILL CONNECTED TO THE INSERTION HANDLE. HE THEN USED A NON-SYNTHES TIBIAL NAIL SUPRA PATELLA AND HAD NO ISSUES. IT WAS REPORTED THERE WAS A NINETY TO ONE-HUNDRED-TWENTY (90-120) MINUTE DELAY TO THE PROCEDURE, BUT THAT THE PROCEDURE AS SUCCESSFULLY COMPLETED WITH NO HARM TO THE PATIENT. CONCOMITANT DEVICES: LOCKING SCREW (PART/LOT UNKNOWN, QUANTITY UNKNOWN); INSERTION HANDLE (PART 03.010.440, LOT 170223-101, QUANTITY 1). THIS IS REPORT 1 OF 2 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    39047 CANN CONNECTING SCR F/PERCUTAN INSTRUMENTS FOR NAILS-EX GUIDE FZX OBERDORF : SYNTHES PRODUKTIONS GMBH U279896 07611819501706

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention