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

Catalog Number 01.26.65.35

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

Upon the implantation of the 35 mm cc trio screw, the surgeon could not get the screw to sit flush in the acetabular.I attempt to get the screw to seat flush to allow proper seating of the liner, the screw head sheared off.The head of the screw was removed from the patient but the shaft still remains in the acetabular.The screw head which broke off will be returned for analysis.Ref mfr #3005180920-2015-00027.

• 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
• MDR Report Key: 4609431
• MDR Text Key: 5760136
• Report Number: 3006639916-2015-00027
• Device Sequence Number: 1
• Product Code: MEH
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Source Type: Unknown
• Reporter Occupation: Not Applicable
• Type of Report: Initial
• Report Date: 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: Health Professional
• Device Expiration Date: 10/31/2019
• Device Catalogue Number: 01.26.65.35
• Device Lot Number: 145934
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 03/10/2015
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 03/13/2015
• Distributor Facility Aware Date: 02/11/2015
• Device Age: 1 MO
• Event Location: Hospital
• Date Report to Manufacturer: 03/13/2015
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other