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

Device Problem Difficult To Position (1467)

Patient Problem No Information (3190)

Event Type  malfunction  

Manufacturer Narrative

This report will be amended when our investigation is complete.

Event Description

It is reported that the surgeon was not able target the nail to the proximal dynamic slot with the targeting guide.

Manufacturer Narrative

No product, part number, or lot number was returned for evaluation.The condition of the device could not be observed and the device history record could not be reviewed.This device is used for treatment since no lot number was available no complaint history review could be conducted for the related lot number part number combination.The root cause of the inability to target with the targeting guide could not be determined.

• Brand Name: UNKNOWN ZIMMER NATURAL NAIL SHORT NAIL
• Type of Device: TRAUMA PROSTHESIS
• Manufacturer (Section D): ZIMMER, INC.; 1800 west center street; warsaw IN 46580
• Manufacturer (Section G): ZIMMER, INC.; 1800 west center street; warsaw IN 46580
• Manufacturer Contact: carrie schneider ; p.o. box 708; warsaw, IN 46581-0708 ; 8006136131
• MDR Report Key: 5771853
• MDR Text Key: 48833429
• Report Number: 0001822565-2016-02257
• Device Sequence Number: 1
• Product Code: JDP
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PN/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,health profession
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 06/07/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/06/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/16/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: N/A
• Patient Sequence Number: 1