MAUDE Adverse Event Report: ZIMMER, TURPEAUX INDUSTRIAL PARK MULTIPOLAR BIPOLAR CUP; KWY

Catalog Number 00500105100

Device Problem Compatibility Problem (2960)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/20/2015

Event Type  malfunction  

Manufacturer Narrative

Information was received from a distributor who is not required to complete form 3500a.(b)(4).Other device used: catalog #00500105028, multipolar bipolar cup liner, lot #62955021 this report will be amended when our investigation is complete.

Event Description

It is reported the shell and liner would not fit together.

Manufacturer Narrative

This report is being amended to reflect changes in sections.Visual examination of the returned bipolar cup confirmed the metal ring was returned assembled and would not move freely within the window.Dimensional evaluation of the cup and metal ring verified that these conformed to print specifications where measured.Gouges were noted on the external liner surface.The metal ring was inspected and noted that the tip is damaged.This reported device is used for treatment.Review of complaint history identified no previous complaints for the part-lot combination associated with the cup.When both tabs are not in the slot, the locking ring will not expand adequately to accept the liner.This can result in, as described in this complaint, difficulty to insert the liner into the bipolar metal shell.Step by step assembly instruction is provided both in the surgical technique and package insert and there is instruction for checking the position and condition of the locking ring prior to assembly.With the information provided a likely cause for the reported issue is user not adhering to the instructions provided in the surgical technique.

• Brand Name: MULTIPOLAR BIPOLAR CUP
• Type of Device: KWY
• Manufacturer (Section D): ZIMMER, TURPEAUX INDUSTRIAL PARK; rt. #1, km 123.4; bldg. #1; mercedita PR 00715
• Manufacturer (Section G): TURPEAUX INDUSTRIAL PARK; rt. #1, km 123.4; bldg. #1; mercedita PR 00715
• Manufacturer Contact: kevin escapule ; p.o. box 708; warsaw, IN 46581-0708 ; 8006136131
• MDR Report Key: 5068517
• MDR Text Key: 25676668
• Report Number: 2648920-2015-00335
• Device Sequence Number: 1
• Product Code: KWY
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,health profession
• Reporter Occupation: Medical Equipment Company Technician/Representative
• Type of Report: Initial,Followup
• Report Date: 08/20/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/10/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/30/2023
• Device Catalogue Number: 00500105100
• Device Lot Number: 62523210
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/26/2015
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/15/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/18/2013
• 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