BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNREAM FLEXSHAFT

    MDR report key: 7324832 · Received March 8, 2018

    Report

    Report Number
    8030965-2018-51856
    Event Type
    Malfunction
    Date Received
    March 8, 2018
    Date of Event
    February 9, 2018
    Report Date
    February 9, 2018
    Manufacturer
    OBERDORF SYNTHES PRODUKTIONS GMBH
    Product Code
    HTO
    UDI-DI
    07611819243668
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    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. UDI A DEVICE HISTORY RECORD REVIEW WAS PERFORMED FOR THE SUBJECT DEVICE: PART NO.: 352.040 LOT NO.: 2090794 MANUFACTURING LOCATION: BETTLACH RELEASE TO WAREHOUSE DATE: 09.JUN.2004 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. H3, H6: A MANUFACTURING INVESTIGATION WAS PERFORMED FOR THE SUBJECT DEVICE: THE MANUFACTURING DOCUMENT OF THE FLEXIBLE SHAFT WERE REVIEWED AND NO COMPLAINT RELATED ISSUES WERE FOUND, THE DEVICE WAS MANUFACTURED IN THE YEAR 2004 ACCORDING TO THE SPECIFICATION. A VISUAL INSPECTION WAS PERFORMED AND NO DAMAGE AT THE FLEXIBLE SHAFT COULD BE OBSERVED. IN GENERAL IS THE DEVICE IS IN A OFTEN USED CONDITION, CONCORDANT WITH THE AGE OF THE DEVICE. THE FUNCTION TEST SHOWS THAT THE ALSO RECEIVED REAMER HEAD CAN BE ATTACHED AND REMOVED FROM THE SHAFT AS REQUIRED. ALSO WE FOUND THAT THE REAMER HEAD IS LOCKED ON THE SHAFT SOON THE ALSO RECEIVED REAMING ROD IS IN PLACE. NO PRODUCT RELATED ISSUE COULD BE DETECTED. ACCORDING TO THE COMPLAINT DESCRIPTION WAS THE SYNREAM SYSTEM USED WITHOUT REAMING ROD WHEN THE HEAD CAME OFF. THIS IS AN USE ERROR BECAUSE THE REAMING HEAD IS NOT SECURED ON THE FLEXIBLE SHAFT WHEN THE REAMING ROD IS NOT INSERTED. IN THIS RELATION WE WOULD LIKE TO POINT OUT THE SYNREAM SURGICAL TECHNIQUE, STATED: PRECAUTION: NEVER REAM WITHOUT USING A REAMING ROD, AS IT SECURES THE CONNECTION BETWEEN THE REAMER HEAD AND THE FLEXIBLE SHAFT. 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

    DEVICE IS AN INSTRUMENT AND IS NOT IMPLANTED/EXPLANTED. 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 RECORD REVIEW WAS 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.

    Additional Manufacturer Narrative · 1

    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 THE DEVICES WERE USED IN SURGERY FOR FEMORAL TROCHANTERIC FRACTURE ON (B)(6) 2018. WITHOUT USING REAMING ROD (352.032) BEFOREHAND, THE SURGEON INSERTED THE ASSEMBLED REAMING UNIT (COMPOSED OF 352.110 REAMER HEAD, 352.040 FLEXIBLE SHAFT AND 351.150 T-HANDLE IN QUESTION) INTO THE MEDULLARY CAVITY. THEN, THE REAMER HEAD CAME OFF THE FLEXIBLE SHAFT AROUND THE NARROWEST MEDULLARY CAVITY. THE SURGEON RE-CONNECTED THE REAMER HEAD AND THE FLEXIBLE SHAFT IN THE MEDULLARY CAVITY, TOOK THE ENTIRE REAMING UNIT, AND COMPLETED THE SURGERY WITH A TEN-MINUTE DELAY. THERE WAS NO ADVERSE CONSEQUENCE TO THE PATIENT, WHO HAD NO FRAGMENT LEFT IN HER BODY. IT WAS CONFIRMED THAT THE SURGEON HAD NOT BEEN GIVEN A PROPER GUIDANCE ON THE REAMING-DEVICE USAGE. CONCOMITANT PARTS: ONE QTY, P/N 351.150, L/N 2088577. ONE QTY, P/N 354-5295, L/N 0000657475. THIS IS REPORT 2 OF 3 FOR (B)(4).

    Description of Event or Problem · 1

    CONCOMITANT MEDICAL PRODUCTS: 1 QTY, SYNREAM REAMING ROD Ø2.5 SHORT L950, P/N 352.032, L/N 5942020.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    166662 SYNREAM FLEXSHAFT REAMER HTO OBERDORF SYNTHES PRODUKTIONS GMBH 2090794 07611819243668

    Patients

    Seq Age Sex Outcome Treatment
    1 92 YR