MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA VERSAFITCUP CC CANCELLOUS BONE SCREW Ø 6.5 L 35

Catalog Number 01.26.65.35

Device Problem Break (1069)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 09/14/2015

Event Type  malfunction  

Manufacturer Narrative

Batch review performed on 14 october 2015: lot 148376: (b)(4) items manufactured and released on 26 march 2015.Expiration date: 2020-02-29.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.On 01 october 2015 the r&d project manager analyzed the retrieved head of the screw: signs can be seen on the head of the screw: they can be caused by the repeated contact between the head of the screw and probably the shell during the insertion of the screw.The thread of the screw is not available, so we cannot reach any other conclusion.It is not possible to determine any conclusion on the root cause of the problem.

Event Description

Whilst screw being placed into acetabular cup - head sheared off - head retained for analysis.However thread left in place - embedded below cup so no interference with liner.

Manufacturer Narrative

On 04 dec 2015 it was prepared a final report with the information already submitted in the initial report.On 12 dec 2015 it was sent to the initial reporter and the case was closed.

• Brand Name: VERSAFITCUP CC CANCELLOUS BONE SCREW Ø 6.5 L 35
• Type of Device: BONE SCREW
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• Manufacturer (Section G): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, 6874 ; SZ 6874
• Manufacturer Contact: stefano baj ; strada regina; castel san pietro, 6874 ; SZ 6874 ; 91 6966060
• MDR Report Key: 5150690
• MDR Text Key: 28599626
• Report Number: 3005180920-2015-00234
• Device Sequence Number: 1
• Product Code: LZO
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K103352
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 12/22/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/14/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/29/2020
• Device Catalogue Number: 01.26.65.35
• Device Lot Number: 148376
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/25/2015
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 09/14/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/26/2015
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 38 YR
• Patient Weight: 99