MAUDE Adverse Event Report: ZIMMER INC UNKNOWN ZIMMER ULNA REAMER; ELBOW INSTRUMENT

Device Problem Break (1069)

Patient Problem No Information (3190)

Event Date 11/26/2015

Event Type  Injury  

Manufacturer Narrative

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

Event Description

It is reported the reamer broke while the surgeon was reaming the ulna.

Manufacturer Narrative

No devices or photos were returned; therefore a determination on the condition of the components could not be made.The provided part number is for an implant stem not the reported failed reamer.The reamer's part number and lot number are unknown therefore a review of its device history records and complaint search could not be performed.The device was used for treatment.Multiple attempts were made for additional information however none have been received to date.With the provided information an exact cause could not be determined.

• Brand Name: UNKNOWN ZIMMER ULNA REAMER
• Type of Device: ELBOW INSTRUMENT
• 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: 5322648
• MDR Text Key: 34243467
• Report Number: 1822565-2015-02725
• Device Sequence Number: 1
• Product Code: JDC
• Combination Product (y/n): N
• Reporter Country Code: UK
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 11/26/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/26/2015
• Initial Date FDA Received: 12/23/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 03/24/2016
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other