MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA VERSAFITCUP CC TERMINAL CUP IMPACTOR FOR METAL BACK CC; SURGICAL INSTRUMENT FOR HIP

Catalog Number 01.15.10.0261

Device Problem Failure to Disconnect (2541)

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

Event Date 05/03/2018

Event Type  malfunction  

Manufacturer Narrative

Batch review performed on 01 june 2018: lot 1213128: (b)(4) items manufactured and released on 05 february 2013.No anomalies found related to the issue.A similar event on the same lot registered up to now.Visual inspection performed on 29 may 2018 by r&d product manager: during the analysis it is evaluated that the terminal is blocked inside the cup.We have dislocated the terminal from the cup using the screwdriver ref (b)(4).Looking at the threaded part of the terminal we evaluated that the tip part is little bit deformed.In addition the balinit-c coating is scratched.Also on the cup there are some residual of balinit-c.It seem that the surgeon not screwed correctly the terminal in the cup before impaction and this caused the deformation of the threaded tip together with the scratched of the balinit-c coating.

Event Description

The terminal cup impactor stuck into the cup and can't be disconnected.The surgeon used another cup and the long straight multifunction handle to complete the surgery.

• Brand Name: VERSAFITCUP CC TERMINAL CUP IMPACTOR FOR METAL BACK CC
• Type of Device: SURGICAL INSTRUMENT FOR HIP
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• Manufacturer (Section G): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• Manufacturer Contact: stefano baj ; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• MDR Report Key: 7560669
• MDR Text Key: 109942399
• Report Number: 3005180920-2018-00393
• Device Sequence Number: 1
• Product Code: LXH
• Combination Product (y/n): N
• Reporter Country Code: GM
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 06/01/2018

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
• Device Operator: Health Professional
• Device Catalogue Number: 01.15.10.0261
• Device Lot Number: 1213128
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/29/2018
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 03/05/2018
• Initial Date FDA Received: 06/01/2018
• Was Device Evaluated by Manufacturer?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Weight: 62