MAUDE Adverse Event Report: MEDACTA INTERNATIONAL, SA VERSAFITCUP CC BONE SCREW 0 6,5 L 35 MM; BONE CANCELLOUS BONE SCREW

Device Problems Break (1069); Entrapment of Device (1212); Difficult To Position (1467); Detachment of Device or Device Component (2907)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 02/11/2015

Event Type  Injury  

Event Description

(b)(4).

Manufacturer Narrative

Batch review performed on 03/13/2015: lot 145934: (b)(4) items manufactured and released on 01/14/2015.Expiry date: 10/31/2019.No anomalies found related to the problem occurred.To date, (b)(4) items of the lot have been sold without any similar issue.Further evaluations are reported in annex 1.

Manufacturer Narrative

On (b)(6) 2015 it was prepared a final report with the information collected during the investigation, already reported in the initial report.On (b)(6) 2015 the report was sent to the initial report and the case was closed.

• Brand Name: VERSAFITCUP CC BONE SCREW 0 6,5 L 35 MM
• Type of Device: BONE CANCELLOUS BONE SCREW
• Manufacturer (Section D): MEDACTA INTERNATIONAL, SA; castel san pietro ; SZ
• Manufacturer (Section G): MEDACTA INTERNATIONAL, SA; strada regina 6874; castel san pietro ; SZ
• Manufacturer Contact: erin baumstark ; 3128782381
• MDR Report Key: 4609412
• MDR Text Key: 15315219
• Report Number: 3005180920-2015-00027
• Device Sequence Number: 1
• Product Code: MEH
• Combination Product (y/n): N
• PMA/PMN Number: K103352
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,other
• Type of Report: Initial,Followup
• Report Date: 07/29/2015,03/13/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/13/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 07/29/2015
• Date Report to Manufacturer: 07/29/2015
• Date Manufacturer Received: 01/11/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/01/2015
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other