MAUDE Adverse Event Report: ZIMMER, INC. FLEXIBLE CANNULATED REAMER

Catalog Number 00840107202

Device Problem Break (1069)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/12/2015

Event Type  malfunction  

Event Description

It is reported that as the surgeon was reaming the ulna, he realized the instrument had broken into 2 separate pieces.The surgeon then tried using the next size and had the same result.There was no harm to the patient.

Manufacturer Narrative

This report will be amended when our investigation is complete.

Manufacturer Narrative

The instructions for use included with the reamers states "do not subject instruments to high loads and/or impacts as breakage can occur." as returned both flexible reamers are disconnected where the shaft connects to the drive connector.The connection was tested and confirmed the presence of epoxy inside the connectors.The reamers were dimensionally inspected and found to be conforming where measured.Review of the device history records did not find any deviations or anomalies.The devices were used for treatment.No other complaints of any type have been reported for 5.5mm reamers lot.Based on its lot number the 5.5mm reamer has an approximate field age of 13 months.Based on its lot number the 6mm reamer has an approximate field age of 14 months.With the provided information an exact cause could not be determined.Based on the available information, the need for corrective action is not indicated.Should additional substantive information be received, the complaint will be reopened.Zimmer, inc.Considers the investigation closed.

• Brand Name: FLEXIBLE CANNULATED REAMER
• 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: 4959968
• MDR Text Key: 15309489
• Report Number: 1822565-2015-01370
• Device Sequence Number: 1
• Product Code: JDC
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Distributor,distributor,health prof
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 07/01/2015

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: 00840107202
• Device Lot Number: 62651934
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 07/01/2015
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 07/01/2015
• Initial Date FDA Received: 07/29/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/01/2014
• 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
• Treatment: CATALOG #00840107201, LOT #62691216