MAUDE Adverse Event Report: ZIMMER INC FLEXIBLE CANNULATED REAMER, 5.5 MM; JDC

Catalog Number 00840107201

Device Problem Break (1069)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/25/2015

Event Type  malfunction  

Manufacturer Narrative

(b)(4).This report will be amended when our investigation is complete.

Event Description

It is reported the power tool coupling adaptor has separated from shaft of the reamer.

Manufacturer Narrative

This report will be amended when our investigation is complete.

Manufacturer Narrative

The instructions for use included with the reamer states "do not subject instruments to high loads and/or impacts as breakage can occur." as returned the flexible reamer is disconnected where the shaft connects to the drive connector.The shaft had been coupled to the drive connector through the use of epoxy.The reamer was dimensionally inspected and found to be conforming where measured.Review of the device history records did not find any deviations or anomalies.The reamer was used for treatment.Based on its lot number the reamer has an approximate field age of 22 months.This failure is the result of exposing the reamer to greater than anticipated loading causing the epoxy to fail and the shaft to separate from the connector.

• Brand Name: FLEXIBLE CANNULATED REAMER, 5.5 MM
• Type of Device: JDC
• Manufacturer (Section D): ZIMMER INC; p.o. box 708; warsaw IN 46581 0708
• Manufacturer Contact: kevin escapule ; p.o. box 708; warsaw, IN 46581-0708 ; 8006136131
• MDR Report Key: 5311147
• MDR Text Key: 34353780
• Report Number: 1822565-2015-02692
• Device Sequence Number: 1
• Product Code: JDC
• Combination Product (y/n): N
• Reporter Country Code: SW
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,health pr
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 11/25/2015

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: 00840107201
• Device Lot Number: 62571106
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/27/2016
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/25/2015
• Initial Date FDA Received: 12/18/2015
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 02/22/2016; 02/29/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/20/2014
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1