BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EXPERT A2FN NAIL Ø12 R CANN L420 TAN LIG

    MDR report key: 6406957 · Received March 15, 2017

    Report

    Report Number
    1000562954-2017-10028
    Event Type
    Injury
    Date Received
    March 15, 2017
    Report Date
    February 21, 2017
    Manufacturer
    SYNTHES MEZZOVICO
    Product Code
    JDS
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE USED FOR TREATMENT, NOT DIAGNOSIS. DEVICE IS NOT DISTRIBUTED IN THE UNITED STATES, BUT IS SIMILAR TO DEVICE MARKETED IN THE USA (B)(4). CONCOMITANT MEDICAL PRODUCTS: HIP SCREW T25 Ø 6.5MM (PART# 04.003.028S / LOT: 9220110 / QUANTITY 1); HIP SCREW T25 Ø 6.5MM (PART# 04.003.029S / LOT: 9060769 / QUANTITY 1); LOCKING SCREW Ø 5.0MM (PART#04.005.540S / LOT: 9024127 / QUANTITY 1); LOCKING SCREW Ø 5.0MM (PART# 04.005.548S / LOT: 8246902 / QUANTITY 1). (B)(6). DEVICE HISTORY RECORDS REVIEW WAS CONDUCTED. THE REPORT INDICATES THAT THE: MANUFACTURING LOCATION: (B)(6); PART: 04.009.564S / LOT: 3345468; MANUFACTURING LOCATION: (B)(4); MANUFACTURING DATE: 05 FEBRUARY 2010; EXPIRY DATE: 01 JANUARY 2020. NO NCR'S WERE GENERATED DURING PRODUCTION THAT WOULD CONTRIBUTE TO THE COMPLAINT CONDITION. THE REVIEW OF THE DEVICE HISTORY RECORD SHOWS THAT THERE WERE NO ISSUES DURING THE MANUFACTURE OF THE PRODUCT THAT WOULD CONTRIBUTE TO THE COMPLAINT CONDITION. 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. CLARIFICATION. INITIAL MEDWATCH REPORT #(B)(4) DEVICE HISTORY RECORD REVIEW RESULTS REPORTED BOTH (B)(4) AS THE MANUFACTURER OF THE SUBJECT DEVICE. (B)(4) WAS ENTERED IN ERROR. THE SUBJECT DEVICE LOT WAS MANUFACTURED IN (B)(4). THE SUBJECT DEVICE IS NOT EXPECTED TO BE RETURNED TO THE SYNTHES MANUFACTURER FOR EVALUATION. 510(K): DEVICE IS NOT DISTRIBUTED IN THE UNITED STATES, BUT IS SIMILAR TO DEVICE MARKETED IN THE USA. 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. PATIENT HEIGHT IS (B)(6). BMI CALCULATION IS (B)(6). 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 ON AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED THAT AN A2FN NAIL WAS INSERTED IN PATIENT FOR A FEMUR FRACTURE, INTRA-OP AND POST OP X-RAYS TAKEN AND DID NOT SHOW ANY EVIDENCE OF A2FN RECON HIP SCREWS MISSING NAIL. SUBSEQUENTLY, PATIENT DEVELOPED SOME PAIN 4-5 MONTHS POST OP AND X-RAY THEN REVEALED THE HIP SCREWS HAD MISSED THE NAIL COMPLETELY AND NAIL HAS MIGRATED UPWARDS. PER THE SURGEON, THE NAIL HAS BEEN REMOVED IN ANOTHER OPERATION AND CHANGED TO A PLATE. IMPLANTS WERE DISCARDED AFTER THE SECOND OPERATION. PATIENT: DISCHARGED. PATIENT STATUS/ OUTCOME AFTER REVISION SURGERY ARE STABLE. REVISION SURGERY WAS COMPLETED SUCCESSFULLY. NO PROLONGATION OF THE SURGERY WAS REPORTED. THIS COMPLAINT INVOLVES 1 PART. THE EVENTS WERE CAPTURED IN 2 COMPLAINTS: (B)(4) = INITIAL SURGERY - WHERE THE SCREW MISS THE NAIL AIMING ARM AND INSERTION HANDLE ARE CAPTURED UNDER (B)(4). (B)(4) = POST-OP PAIN BECAUSE OF MIGRATED NAIL. CONCOMITANT MEDICAL PRODUCTS: HIP SCREW T25 Ø 6.5MM (PART# 04.003.028S / LOT: 9220110 / QUANTITY 1); HIP SCREW T25 Ø 6.5MM (PART# 04.003.029S / LOT: 9060769 / QUANTITY 1); LOCKING SCREW Ø 5.0MM (PART#04.005.540S / LOT: 9024127 / QUANTITY 1); LOCKING SCREW Ø 5.0MM (PART# 04.005.548S / LOT: 8246902 / QUANTITY 1). THIS REPORT IS 1 OF 1 FOR (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    189557 EXPERT A2FN NAIL Ø12 R CANN L420 TAN LIG NAIL, FIXATION, BONE JDS SYNTHES MEZZOVICO 3345468

    Patients

    Seq Age Sex Outcome Treatment
    1 33 YR Required Intervention HIP SCREW T25 Ø 6.5MM (ART# 04.003.029S / LOT: 90| HIP SCREW T25 Ø 6.5MM PART# 04.003.028S| LOCKING SCREW Ø 5.0MM PART# 04.005.548S / LOT: 82| LOCKING SCREW Ø 5.0MM PART#04.005.540S / LOT: 902