MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA CANCELLOUS BONE SCREW, FLAT HEAD Ø 6,5 L 40

Catalog Number	01.32.6540
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Date of Event	01/30/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Clinical evaluation performed by medical affairs director on 16 february 2018 intraoperatively a cancellous bone screw broke during insertion.Part of the broken screw was left in the bone and the surgery was completed successfully.This event may be due to excessive tightening torque but the reason cannot be determined.Batch review performed on 26 february 2018 lot 176925: (b)(4) items manufactured and released on 23 october 2017.Expiration date: 2022-10-11 no anomalies found related to the problem.To date, (b)(4) items of the same lot have been already sold without any similar reported event.
Event or Problem Description
During surgery the screw head broke off.The screw remains in the patient.The surgery was completed successfully.Instrument used to create the hole: (b)(4) drill guide; (b)(4) drill shaft; (b)(4) drill bit.The hole was performed with the correct inclination.The screw was inserted with the ref (b)(4) (handle) and with the ref (b)(4) (driver).

• Brand Name: CANCELLOUS BONE SCREW, FLAT HEAD Ø 6,5 L 40
• Common Device Name: CANCELLOUS BONE SCREW, FLAT HEAD
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• MDR Report Key: 7306126
• Report Number: 3005180920-2018-00103
• Device Sequence Number: 19395491
• Product Code: LPH
• UDI-Device Identifier: 07630030812415
• UDI-Public: 07630030812415
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K103721
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 03/01/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 10/11/2022
• Device Catalogue Number: 01.32.6540
• Device Lot Number: 176925
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/30/2018
• Initial Report FDA Received Date: 03/01/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 80 YR