MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA VERSAFITCUP GENERAL LONG STRAIGHT MULTIFUNCTION HANDLE; SURGICAL INSTRUMENT FOR HIP

Catalog Number 01.26.10.0162

Device Problem Device Issue (2379)

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

Event Date 02/01/2018

Event Type  malfunction  

Manufacturer Narrative

Batch review performed on 28 february 2018 (b)(4).No anomalies found related to the problem.No similar event registered on this lot.Versafitcup dm impacting ring size 50 reference 01.26.10.0135: (b)(4).No anomalies found related to the problem.No similar cases registered on this lot.Visual inspection performed by r&d product manager on 26 february 2018: the impacting ring #50 (ref.01.26.10.0135) thread m10 is worn out.This could have compromised also the thread of the long straight multifunction handle (ref.01.26.10.0162) causing some problems on the connections between the two references.While the impacting ring #50 (ref.01.26.10.0135) has an old lot number (097833) the use during the time provided natural wear on the external diameter that could have compromised the coupling with the cup.

Event Description

Failure of coupling between handle and impacting ring, it would not start in the threads.Also, the plate disengaged from the cup twice in the wound and the cup had to be removed.Twenty-five (25) minutes of delay registered that was caused by the inserter and impactor plate not threading together properly and the surgeon and the tech kept trying to make them screw together.The selected implant was finally able to be implanted with the damaged instrument.

• Brand Name: VERSAFITCUP GENERAL LONG STRAIGHT MULTIFUNCTION HANDLE
• Type of Device: SURGICAL INSTRUMENT FOR HIP
• 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
• MDR Report Key: 7309536
• MDR Text Key: 101705350
• Report Number: 3005180920-2018-00117
• Device Sequence Number: 1
• Product Code: LXH
• Combination Product (y/n): N
• Reporter Country Code: US
• 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: 03/02/2018

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: 01.26.10.0162
• Device Lot Number: 1412977
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/15/2018
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 02/01/2018
• Initial Date FDA Received: 03/02/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/17/2015
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Other