BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SCREW, FIXATION, BONE

    MDR report key: 4899718 · Received July 8, 2015

    Report

    Report Number
    3009450884-2015-10061
    Event Type
    Malfunction
    Date Received
    July 8, 2015
    Report Date
    June 29, 2015
    Manufacturer
    SYNTHES GRENCHEN
    Product Code
    HWC
    PMA / PMN Number
    PK112583
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL NARRATIVE: PATIENT INFORMATION IS UNKNOWN. THIS REPORT IS FOR ONE (1) UNKNOWN SCREW. THERE ARE FIVE (5) POSSIBLE PART/LOT COMBINATIONS FOR THIS BROKEN SCREW: PART 401.818S / LOT 8979780 - 2.0MM TI CORTEX SCREW SELF-TAPPING 18MM ¿ EXPIRY DATE: MAY 1, 2025. PART 401.814S / LOT 9014654 - 2.0MM TI CORTEX SCREW SELF-TAPPING 14MM ¿ EXPIRY DATE: JUNE 1, 2024. PART 401.814S / LOT 9001828 - 2.0MM TI CORTEX SCREW SELF-TAPPING 14MM ¿ EXPIRY DATE: MAY 1, 2024. PART 401.812S / LOT 9036565 - 2.0MM TI CORTEX SCREW SELF-TAPPING 12MM ¿ EXPIRY DATE: JUNE 1, 2024 PART 401.810S / LOT 9012887 - 2.0MM TI CORTEX SCREW SELF-TAPPING 10MM ¿ EXPIRY DATE: JUNE 1, 2024. DEVICE HAS NOT BEEN EXPLANTED YET. MANUFACTURING DATES: PART 401.818S / LOT 8979780 ¿ MAY 20, 2015. PART 401.814S / LOT 9014654 ¿ JUNE 17, 2014. PART 401.814S / LOT 9001828 ¿ JUNE 6, 2014. PART 401.812S / LOT 9036565 ¿ JUNE 26, 2014. PART 401.810S / LOT 9012887 ¿ JUNE 12, 2014. INVESTIGATION COULD NOT BE COMPLETED AND NO CONCLUSION COULD BE DRAWN AS NO DEVICE WAS RETURNED. A REVIEW OF THE DEVICE HISTORY RECORDS FOR EACH OF THE FIVE (5) POSSIBLE PART/LOT COMBINATIONS WAS CONDUCTED WITH RESULTS AS FOLLOWS: PART: 401.818S / LOT: 8979780. MANUFACTURING LOCATION: (B)(4) - MANUFACTURING DATE: MAY 20, 2015 - EXPIRY DATE: MAY 1, 2025. NO NON-CONFORMANCE REPORTS (NCR) 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. PART: 401.814S / LOT: 9014654. MANUFACTURING LOCATION: (B)(4) - MANUFACTURING DATE: JUNE 17, 2014 - EXPIRY DATE: JUNE 1, 2024. 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. PART: 401.814S / LOT: 9001828. MANUFACTURING LOCATION: (B)(4) - MANUFACTURING DATE: JUNE 6, 2014 - EXPIRY DATE: MAY 1, 2024. 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. PART: 401.812S / LOT: 9036565. MANUFACTURING LOCATION: (B)(4) - MANUFACTURING DATE: JUNE 26, 2014 - EXPIRY DATE: JUNE 1, 2024. 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. PART: 401.810S / LOT: 9012887. MANUFACTURING LOCATION: (B)(4) - MANUFACTURING DATE: JUNE 12, 2014 - EXPIRY DATE: JUNE 1, 2024. 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. 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

    ADDITIONAL NARRATIVE: ADDITIONAL INFORMATION ON X-RAY'S REPORT AND DHR REVIEW SHOWED NO ISSUES AND INVESTIGATION WAS NOT POSSIBLE DUE THE MISSING MATERIAL. X-RAYS REVIEWED BY MEDICAL PROFESSIONAL. 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)(4) AS FOLLOWS: IT WAS REPORTED THAT A PATIENT WAS IMPLANTED WITH A PLATE AND SCREWS ON (B)(6) 2014 FOR ARTHROSIS OF CM JOINT OF THUMB. TWO (2) OF THE IMPLANTED SCREWS WERE DISCOVERED TO BE BROKEN POSTOPERATIVE. THE DISCOVERY OF ONE (1) BROKEN SCREW WAS MADE VIA X-RAY DURING A ROUTINE FOLLOW-UP APPOINTMENT ON (B)(6) 2015 AND IS ADDRESS IN (B)(4). THE OTHER BROKEN SCREW WAS NOT DISCOVERED UNTIL THE END OF (B)(6) 2015. THE SURGEON COMMENTED THAT THE PATIENT WAS NOT LOAD-BEARING IN THE TREATED REGION AT TIME OF BREAKAGE. ALTHOUGH A RE-OPERATION IS EXPECTED, THE PATIENT IS CURRENTLY ONLY UNDER OBSERVATION. THIS REPORT IS FOR ONE (1) UNKNOWN SCREW. THIS REPORT IS 1 OF 1 FOR (B)(4).

    Description of Event or Problem · 1

    UPDATE: JULY 10, 2015 REVIEWED COMPLAINT REPORT AND X-RAYS, IT WAS CONFIRM THAT THE (2) PROXIMAL SCREW HAD BREAKAGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    441895 SCREW, FIXATION, BONE HWC SYNTHES GRENCHEN

    Patients

    Seq Age Sex Outcome Treatment
    1