MAUDE Adverse Event Report: ZIMMER GMBH ZNN CMN NAIL 10MMX21.5CM 130R; ZIMMER NATURAL NAIL SYSTEM CEPHALOMEDU

Catalog Number 47-2493-212-10

Device Problems Difficult to Insert (1316); Device Operates Differently Than Expected (2913)

Patient Problem No Code Available (3191)

Event Date 05/20/2014

Event Type  Injury  

Event Description

It was reported that the surgeon wanted to implant the znn cmn nail 10mmx21.5cm 130r and was not able to insert the ser-screw.The surgeon decided to exchange the nail, set screw and lag-screw.It was stated that the surgery was extended for more than 2 hours.

Manufacturer Narrative

The manufacturer did not receive devices, x-rays, or other source documents for review.The device history records were reviewed and found to be conforming.A cause for this specific event cannot be ascertained from the information provided.Should additional information become available and an investigation result be available, that changes this assessment, an amended medical device report will be submitted.(b)(4).

• Brand Name: ZNN CMN NAIL 10MMX21.5CM 130R
• Type of Device: ZIMMER NATURAL NAIL SYSTEM CEPHALOMEDU
• Manufacturer (Section D): ZIMMER GMBH; sulzerallee 8; winterthur 8404 ; SZ 8404
• Manufacturer Contact: kevin escapule ; p.o. box 708; warsaw, IN 46581-0708 ; 574267
• MDR Report Key: 3949163
• MDR Text Key: 4535329
• Report Number: 9613350-2014-03633
• Device Sequence Number: 1
• Product Code: JDS
• Combination Product (y/n): N
• Reporter Country Code: JA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 05/22/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/18/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2022
• Device Catalogue Number: 47-2493-212-10
• Device Lot Number: 2673283
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/22/2014
• Date Device Manufactured: 09/01/2012
• 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 Outcome(s): Other