BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PFNA BLADE PERF L85 TAN

    MDR report key: 6559522 · Received May 11, 2017

    Report

    Report Number
    9612488-2017-10209
    Event Type
    Injury
    Date Received
    May 11, 2017
    Report Date
    April 21, 2017
    Manufacturer
    SYNTHES BETTLACH
    Product Code
    KTT
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DUE TO CORRECTED INFORMATION ON CONCOMITANT DEVICES, DATE SHOULD HAVE BEEN REPORTED AS (B)(6) 2017. 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 DEVICE SCREWDRIVER AND CLAMP PART NUMBERS PROVIDED. DEVICE RECEIVED MAY 19, 2017. EVALUATION WAS PERFORMED ON RETURNED DEVICE. EVALUATION RESULTS ARE AS FOLLOWS: RECEIVED PART: A 1 X 04.027.032S / PFNA BLADE PERF L85 TAN / LOT NO. L230214 . - AS RECEIVED CONDITION: THE BLADE SHOWS SCRATCHES AND NICKS AT THE SHAFT. THE LASER MARKING WAS READABLE. FURTHERMORE WE FOUND THAT ANODIZED LAYER IS PARTIALLY DISAPPEARED. THE INNER LOCKING SCREW WAS FOUND TO LOW INSIDE THE BLADE. - CONCLUSION: OUR INVESTIGATION HAS SHOWN THAT RECEIVED BLADE HAS SOME SCRATCHES AND NICKS AT THE SHAFT. FURTHERMORE WE FOUND THAT ANODIZED LAYER IS PARTIALLY DISAPPEARED. THE INNER LOCKING SCREW WAS FOUND TO LOW INSIDE THE BLADE. THE MANUFACTURING REVIEW SHOWS THAT THE PRODUCTION PROCEDURE WAS ACCORDING TO THE SPECIFICATIONS AND THERE WERE NO ISSUES THAT WOULD CONTRIBUTE TO THIS COMPLAINT CONDITION. A FUNCTIONAL TEST WAS PERFORMED BY THE CHU DEPARTMENT ACCORDING THE ACTUAL SURGICAL TECHNIQUE WITH THE RESULT THAT THE ARTICLE IS FULLY FUNCTIONAL. DURING THE INVESTIGATION THE LOCKING SCREW WAS SCREWED BACK INTO POSITION WITH A STANDARD HEX-WRENCH AND AFTERWARDS THE DEVICE WAS FULLY FUNCTIONAL AGAIN, LOCKING AND UNLOCKING COULD BE PERFORMED AS REQUIRED WITH AN IMPACTOR. UNFORTUNATELY WE ARE NOT ABLE TO DETERMINE THE EXACT CAUSE OF THIS OCCURRENCE AS NO DETAILED CLINICAL INFORMATION IS PROVIDED. THE ARTICLE 04.027.032S WITH LOT NO L230214 WAS MANUFACTURED IN A QUANTITY OF (B)(4) PIECES ON DECEMBER 2016. WE ARE NOT AWARE OF ANY QUALITY PROBLEMS OR FAILURES CAUSED BY A FAULTY PRODUCT ON THE ARTICLE. ALSO WE ARE NOT AWARE OF ANY OTHER COMPLAINT FOR THIS ARTICLE- AND LOT NUMBER COMBINATION. BASED ON THE EVALUATION RESULTS WE ASSUME THAT INCORRECT HANDLING DID MOST LIKELY LEAD TO THE COMPLAINED MALFUNCTION. THE DESIGN AND CLINICAL RISK MANAGEMENT (DCRM) DOCUMENT, WAS REVIEWED AND FOUND TO ADEQUATELY ADDRESS THE HARM OF THIS COMPLAINT CONDITION. HOSPITAL CONTACT IS PHYSICIAN, DID NOT ALSO NOTIFY FDA. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE. DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS.

    Additional Manufacturer Narrative · 1

    DEVICE USED FOR TREATMENT, NOT DIAGNOSIS. (B)(4). DEVICE IS NOT DISTRIBUTED IN THE UNITED STATES, BUT IS SIMILAR TO DEVICE MARKETED IN THE USA. DEVICE MALFUNCTIONED INTRA-OPERATIVELY AND WAS NOT IMPLANTED / EXPLANTED. DEVICE IS NOT EXPECTED TO BE RETURNED FOR MANUFACTURER REVIEW/INVESTIGATION. (B)(6). (B)(4): THERE WAS A DELAY TO THE SURGERY BECAUSE THEY HAD TO REMOVE THE DEFECTIVE MATERIAL, TO RELEASE IT FROM THE ANCILLARY AND TO IMPLANT A NEW BLADE. PATIENT IMPACT WAS LOW BUT THEY HAD ONLY ONE SPECIMEN OF THE AFFECTED BLADE, FOR THIS REASON THEY HAD TO USE THE BLADE OF THE NEXT LOWER SIZE. DEVICE HISTORY RECORDS REVIEW WAS CONDUCTED. THE REPORT INDICATES THAT THE: PART: 04.027.032S / LOT: L23021; MANUFACTURING LOCATION: (B)(4); MANUFACTURING DATE: 20.DEC.2016 EXPIRY DATE: 01.DEC.2026; 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. 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

    CONCOMITANT REPORTED PART: A 1X UNKNOWN SCREWDRIVER 356.823 LOT UNKNOWN. A 1X UNKNOWN CLAMP J759040 LOT UNK. A 1X INSERTION HANDLE (PART 03.010.405 LOT UNKNOWN). A 1X IMPACTOR (PART 356.823 LOT UNKNOWN).

    Description of Event or Problem · 1

    DEVICE REPORT FROM SYNTHES ON AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT THE CUSTOMER HAD AN ISSUE WITH A PROXIMAL FEMORAL NAIL ANTIROTATION BLADE (PFNA). NO FURTHER INFORMATION AVAILABLE AT THE MOMENT. AN INITIAL INTERVENTION FOR FRACTURE OSTEOSYNTHES OF TROCHANTERIC MASS WAS PERFORMED. THE PROBLEM OCCURRED DURING THE LOCKING OF THE PFNA HELICAL BLADE AFTER IMPLANTATION IN THE PATIENT. THE BLADE WAS TURNING IN THIN AIR, NO LOCKING BUT RELEASE OF THE SCREWDRIVER. THEY USED THE EXTRACTION KIT TO REMOVE IT, AS IT NO LONGER PASSED INTO THE INSTALLATION GUIDE. UNSCREWING BY MEANS OF A CLAMP FOR RE-INSTALLATION OF THE SIGHTING GUN AND RESTS NEW BLADE WITHOUT DIFFICULTY. THERE WAS A DELAY TO THE SURGERY BECAUSE THEY HAD TO REMOVE THE DEFECTIVE MATERIAL, TO RELEASE IT FROM THE ANCILLARY AND TO IMPLANT A NEW BLADE. PATIENT IMPACT WAS LOW BUT THEY HAD ONLY ONE SPECIMEN OF THE AFFECTED BLADE, FOR THIS REASON THEY HAD TO USE THE BLADE OF THE NEXT LOWER SIZE. THIS COMPLAINT INVOLVES 1 PART. CONCOMITANT MEDICAL PRODUCTS: 1X UNKNOWN SCREWDRIVER; 1X UNKNOWN CLAMP; 1X INSERTION HANDLE (PART 03.010.405 LOT UNKNOWN); 1X IMPACTOR (PART 356.823 LOT UNKNOWN). THIS REPORT IS 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    341841 PFNA BLADE PERF L85 TAN BLADE, SAW, GENERAL & PLASTIC KTT SYNTHES BETTLACH L230214

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention 1X IMPACTOR (PART 356.823 LOT UNKNOWN)| 1X INSERTION HANDLE (PART 03.010.405 LOT UNKNOWN)| 1X UNKNOWN CLAMP