MAUDE Adverse Event Report: ZIMMER INC UNKNOWN ZIMMER NATURAL NAIL; TRAUMA PROSTHESIS

Device Problem Fracture (1260)

Patient Problem No Information (3190)

Event Type  Injury  

Manufacturer Narrative

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

Event Description

It is reported that the patient has a broken nail.It is unknown if a revision surgery has taken place.

Manufacturer Narrative

No devices or photos were received since the devices still remain implanted; the condition of the components is unknown.Device history records cannot be reviewed since applicable part & lot information is unknown.Surgical notes were not provided; it is unknown whether the components were implanted with the correct fit and orientation as per the surgical technique.No applicable patient history is available for review.A definitive root cause cannot be determined with the information provided.

• Brand Name: UNKNOWN ZIMMER NATURAL NAIL
• Type of Device: TRAUMA PROSTHESIS
• 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: 5326508
• MDR Text Key: 34323360
• Report Number: 1822565-2015-02734
• Device Sequence Number: 1
• Product Code: JDQ
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 12/03/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/24/2015
• 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?: No
• Date Manufacturer Received: 03/08/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other