BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AIMING ARM FOR TI CANNULATED TIBIAL NAILS-EX

    MDR report key: 6559289 · Received May 10, 2017

    Report

    Report Number
    8030965-2017-12275
    Event Type
    Malfunction
    Date Received
    May 10, 2017
    Date of Event
    April 16, 2017
    Report Date
    April 16, 2017
    Manufacturer
    SYNTHES OBERDORF
    Product Code
    FZX
    UDI-DI
    10886982067241
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PATIENT INFORMATION NOT AVAILABLE FOR REPORTING. DEVICE IS AN INSTRUMENT AND IS NOT IMPLANTED/EXPLANTED. DEVICE IS EXPECTED TO BE RETURNED TO SYNTHES MANUFACTURER FOR EVALUATION /INVESTIGATION, BUT HAS YET TO BE RECEIVED. DEVICE HISTORY RECORDS REVIEW WAS CONDUCTED. THE REPORT INDICATES THAT THE: MANUFACTURING LOCATION: DHR REVIEW FOR PART #03.010.052, SUPPLIER LOT # 1331678, SYNTHES LOT #4960169 RELEASE TO WAREHOUSE DATE: 17-MAR-2005 EXPIRATION DATE: N/A MANUFACTURED BY SYNTHES (B)(4). (B)(4) WAS GENERATED FOR ETCHING NOT ON PARTS. ETCHING WAS ADDED AND PARTS WERE ACCEPTED. THIS NON-CONFORMANCE IS NOT RELEVANT TO THE COMPLAINT CONDITION. REVIEW OF THE DEVICE HISTORY RECORD SHOWED THAT THERE WERE NO ISSUES DURING THE MANUFACTURE OF THIS PRODUCT THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. NO SERVICE HISTORY REVIEW CAN BE PERFORMED AS PART NUMBER 03.010.052 WITH LOT NUMBER(S) 1331678/4960169 IS A LOT/BATCH CONTROLLED ITEM. THE MANUFACTURE DATE OF THIS ITEM IS UNKNOWN. THE SOURCE OF THE MANUFACTURE DATE IS THE RELEASE TO WAREHOUSE DATE. THE SERVICE HISTORY REVIEW IS UNCONFIRMED. 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

    A PRODUCT INVESTIGATION WAS COMPLETED: DURING THE INVESTIGATION, NO PRODUCT DESIGN ISSUES OR DISCREPANCIES WERE OBSERVED THAT MAY HAVE CONTRIBUTED TO THE COMPLAINT CONDITION. A VISUAL INSPECTION UNDER 5X MAGNIFICATION, SERVICE AND REPAIR HISTORY REVIEW, DEVICE HISTORY RECORD (DHR) REVIEW, AND DRAWING REVIEW WERE PERFORMED AS PART OF THIS INVESTIGATION. THIS COMPLAINT CANNOT BE CONFIRMED, AS THE AIMING ARM AND INSERTION HANDLE COULD BE REASSEMBLED; THEREFORE, CUSTOMER QUALITY WAS UNABLE TO RECREATE THE COMPLAINT CONDITION. HOWEVER, OTHER VARIABLES COULD HAVE CONTRIBUTED TO THE AIMING ARM AND INSERTION HANDLE NOT ALIGNING CORRECTLY DURING THE PROCEDURE, SUCH AS THE PATIENT¿S CONDITION AND PHYSICAL ATTRIBUTES, OR LATERAL FORCES ON THE CONSTRUCT IMPACTING THE POSITIONING OF THE LOCKING INSTRUMENTATION. PER THE TECHNIQUE GUIDE, THE AIMING ARM IS A PART OF SUPRAPATELLAR INSTRUMENTATION FOR TITANIUM CANNULATED TIBIAL NAILS SYSTEM AND IS USED IN CONJUNCTION WITH THE INSERTION HANDLE FOR PROPER ALIGNMENT AND INSERTION OF TIBIAL INTRAMEDUALLY CANAL. ADDITIONALLY, THE ARM PROVIDES GUIDANCE FOR NAIL LOCKING. THE RADIOLUCENT INSERTION HANDLE (PART #: 03.010.486/LOT #: 9241121) WAS RETURNED AS A CONCOMITANT DEVICE WITHOUT AN ALLEGATION AGAINST THE COMPLAINT CONDITION. THE HANDLE EXAMINED AND HAD NO VISIBLE DAMAGE OR DISCREPANCIES. AS THERE WAS NO DAMAGE TO THE DEVICE NOR ALLEGATION AGAINST THE DEVICE, IT CAN BE REASONABLE STATED THAT THERE IS NO EVIDENCE THAT THIS DEVICE CONTRIBUTED TO THE COMPLAINT CONDITION. THE AIMING ARM WAS ABLE TO BE ASSEMBLED TO THE RETURNED INSERTION HANDLE WITHOUT DIFFICULTY. THE OVERALL CONDITION OF THE DEVICE WAS USED, WITH VISIBLE SCUFF MARKS AND SOME WEARING TO THE BLACK COATING; HOWEVER, THE WEAR WOULD NOT HAVE CONTRIBUTED TO THE COMPLAINT CONDITION. THE ROUND PIN WAS MEASURED AND FOUND TO BE IN THE SPECIFICATION RANGE. THE DIAMOND PIN WAS MEASURED AND FOUND TO BE IN RANGE AT ITS GREATEST WIDTH USING CALIPERS. ADDITIONALLY, THE THUMB SCREW DID NOT HAVE ANY DAMAGE TO THE THREADS. REPLICATION OF THE COMPLAINT CONDITION IS NOT APPLICABLE AS THE DEVICE WAS ABLE TO BE ASSEMBLED TO THE INSERTION HANDLE. THE RELEVANT DRAWINGS FOR THE DEVICE WERE REVIEWED, AND NO DRAWING ISSUES OR DISCREPANCIES WERE NOTED. THE DESIGN IS ADEQUATE FOR ITS INTENDED USE AND DID NOT CONTRIBUTE TO THIS COMPLAINT CONDITION. DURING THE INVESTIGATION, NO PRODUCT DESIGN ISSUES OR DISCREPANCIES WERE OBSERVED THAT MAY HAVE CONTRIBUTED TO THE 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.

    Description of Event or Problem · 1

    IT WAS REPORTED, DURING SURGERY ON (B)(6) 2017, THAT THE PEGS IN THE AIMING ARM DID NOT ALIGN PROPERLY INTO THE HOLES OF THE INSERTION HANDLE. THE PROCEDURE WAS COMPLETED SUCCESSFULLY USING THE AIMING ARM. THE PROCEDURE WAS AN INITIAL SURGERY FOR TIBIAL NAILING. THERE IS NO ALLEGATION AGAINST THE INSERTION HANDLE. THERE WAS NO SURGERY DELAY, AND THE PATIENT¿S OUTCOME WAS STABLE. THERE IS NO PATIENT INFORMATION. THIS COMPLAINT INVOLVES ONE DEVICE. THIS REPORT IS 1 OF 1 FOR (B)(4).

    Description of Event or Problem · 1

    CONCOMITANT DEVICE REPORTED: RADIOLUCENT INSERTION HANDLE (PART 03.010.486, LOT 9241121, QUANTITY 1)

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    340005 AIMING ARM FOR TI CANNULATED TIBIAL NAILS-EX GUIDE FZX SYNTHES OBERDORF 1331678 10886982067241

    Patients

    Seq Age Sex Outcome Treatment
    1