MAUDE Adverse Event Report: ZIMMER, INC. ZNN RETROGRADE FEMORAL NAIL; HSB

Catalog Number 47249434010

Device Problem Difficult to Insert (1316)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/13/2015

Event Type  malfunction  

Event Description

It is reported that after measuring with a depth gauge, the chosen length nail was then inserted into the intercondylar notch of the femur; however, the distal nail end appeared above the greater trochanteric level.The nail was removed, and a shorter nail was used to complete the procedure.

Manufacturer Narrative

This report will be amended when our investigation is complete.

Manufacturer Narrative

The device met specification where measured.Review of the device history records did not find any deviation or anomalies.Dimensions were found conforming to print specifications where measured.A product history search for the femoral nail revealed no additional complaints against the related part and lot combination.All product from this lot have been further distributed.These devices are used for treatment.Based on the technical evaluation and complaint investigation no product issue was identified.

• Brand Name: ZNN RETROGRADE FEMORAL NAIL
• Type of Device: HSB
• Manufacturer (Section D): ZIMMER, INC.; po box 708; warsaw IN 46581 0708
• Manufacturer Contact: kevin escapule ; po box 708; warsaw, IN 46581-0708 ; 8006136131
• MDR Report Key: 4849949
• MDR Text Key: 5932346
• Report Number: 1822565-2015-00931
• Device Sequence Number: 1
• Product Code: HSB
• 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: 05/13/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/16/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2023
• Device Catalogue Number: 47249434010
• Device Lot Number: 62438173
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 06/01/2015
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/24/2015
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 10/01/2013
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 37 YR