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

Catalog Number 01.15.10.0261

Device Problem Failure to Disconnect (2541)

Patient Problem No Information (3190)

Event Date 01/07/2019

Event Type  malfunction  

Manufacturer Narrative

The lot number is not available, so no review of the related documentation could have been performed.

Event Description

The terminal cup was stuck into the implant, a back-up was used to complete the surgery.Even using the t-handle, was not possible to disassemble the terminal cup from the implant.

Manufacturer Narrative

Preliminary investigation performed by r&d project manager: the complaint reports a block of the terminal in the cup and in addition the unscrewing is unsuccessful also using the t-handle screwdriver 01.15.10.0293.It is not possible to determine the root cause because it would have been necessary to evaluate the instrument through a visual inspection, but the instrument is not available.

• Brand Name: AMIS TERMINAL CUP IMPACTOR FOR METAL BACK CC
• Type of Device: SURGICAL INSTRUMENT FOR HIP SURGERIES
• Manufacturer (Section D): MEDACTA INTERNATIONAL SA; strada regina; castel san pietro, switzerland 6874 ; SZ 6874
• MDR Report Key: 8310814
• MDR Text Key: 137456557
• Report Number: 3005180920-2019-00021
• Device Sequence Number: 1
• Product Code: LXH
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 03/08/2019

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
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 01/07/2019
• Initial Date FDA Received: 02/06/2019
• Supplement Dates Manufacturer Received: 01/07/2019
• Supplement Dates FDA Received: 03/08/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other