BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PFNA BLADE PERF L95 TAN

    MDR report key: 5834400 · Received July 29, 2016

    Report

    Report Number
    9612488-2016-10320
    Event Type
    Malfunction
    Date Received
    July 29, 2016
    Date of Event
    July 13, 2016
    Report Date
    July 13, 2016
    Manufacturer
    SYNTHES BETTLACH
    Product Code
    HSB
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DUE TO THE INTRA-OPERATIVE ISSUE, THE DEVICE WAS NOT IMPLANTED/EXPLANTED. COMPLAINANT PART IS EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION, BUT HAS YET TO BE RECEIVED. (B)(6). DEVICE IS NOT DISTRIBUTED IN THE UNITED STATES, BUT IS SIMILAR TO DEVICE MARKETED IN THE USA. PART 04.027.034S, LOT 9890346: MANUFACTURING SITE: (B)(4). MANUFACTURING DATE: MARCH 31, 2016. EXPIRY DATE: MARCH 01, 2026. NO NON-CONFORMANCE REPORTS 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. 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

    MANUFACTURING INVESTIGATION EVALUATION: THE PRODUCT WAS RETURNED IN A PACKAGING DIFFERENT FROM THE ORIGINAL. THE LASER ETCHING WAS READABLE WITH SLIGHT TRACES OF UTILIZATION VISIBLE. A REVIEW OF THE DEVICE HISTORY RECORDS WAS PERFORMED FOR THE AFFECTED LOT WITH NO ABNORMALITIES OR DEVIATIONS DETECTED. ALL DIMENSIONS RELEVANT FOR THE FUNCTION OF THE PRODUCT WERE MEASURED AND FOUND TO FULFILL SPECIFICATIONS. A FUNCTIONAL TEST WAS CARRIED OUT WITH A ¿PASSED¿ RESULT. THE BLADE IS MOUNTABLE AND DEMOUNTABLE, ACCORDING TO SPECIFICATIONS. THE RAW MATERIAL CERTIFICATES WERE CHECKED; ALL OF THE USED RAW MATERIAL WAS FOUND TO FULFILL SPECIFICATIONS. BASED ON THIS INFORMATION, THE COMPLAINT IS RATED AS ¿NOT CONFIRMED¿ AND ¿NOT VALID¿ FROM THE POINT OF VIEW OF THE MANUFACTURING SITE. NO MANUFACTURING RELATED ISSUES WERE IDENTIFIED AND/OR CONFIRMED. PRODUCT INVESTIGATION SUMMARY: ALTHOUGH THERE IS NO SPECIFIC INFORMATION PERTAINING TO TECHNIQUE USED, IT IS LIKELY THAT AN APPLICATION ERROR MAY HAVE TAKEN PLACE DURING THE OPERATION. NO PRODUCT FAULT COULD BE DETECTED. NO CORRECTIVE ACTION REQUIRED. DEVICE 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

    SUBJECT DEVICE HAS BEEN RECEIVED AND IS CURRENTLY IN THE EVALUATION PROCESS. INVESTIGATION IS ONGOING; NO CONCLUSION COULD BE DRAWN AS PRODUCT IS ENTERING THE COMPLAINT SYSTEM. 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 (B)(4) REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED DURING AN INTRAMEDULLARY NAIL PROCEDURE, THE BLADE WOULD NOT LOCK. THE BLADE WAS UNLOCKED USING STANDARD INSTRUMENTATION AND SURGICAL TECHNIQUE; THEN THE BLADE WAS IMPLANTED AS PER STANDARD PROCEDURE. WHEN ATTEMPTING TO LOCK THE BLADE THE GAP BETWEEN BARREL AND BLADE TIP WOULD NOT CLOSE DOWN AND THE BLADE WOULD NOT LOCK. REPETITIVE CLICKING WAS HEARD BY THE SURGEON WHILST TURNING THE IMPACTOR IN THE LOCKING DIRECTION BUT THE BLADE REFUSED TO LOCK. THE IMPACTOR WAS ABLE TO BE DETACHED FROM THE BLADE EVEN THOUGH IT WAS IN THE UNLOCKED POSITION IN THE PATIENT. THE EXTRACTION DEVICE WAS THEN ENGAGED INTO THE BLADE AND IT WAS ABLE TO BE REMOVED. A SECOND 95MM BLADE WAS OPENED AND IMPLANTED INTO THE PATIENT. THIS BLADE LOCKED AS PER STANDARD PROCEDURE AND SO END RESULT OF FIXATION WAS NOT COMPROMISED. STANDARD POST-OPERATIVE OUTCOME IS EXPECTED WITH NO ADVERSE EVENT TO PATIENT. THE CASE DELAYED BY TWENTY-FIVE (25) MINUTES. THIS IS REPORT 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    486504 PFNA BLADE PERF L95 TAN ROD, FIXATION, INTRAMEDULLARY HSB SYNTHES BETTLACH 9890346

    Patients

    Seq Age Sex Outcome Treatment
    1