MAUDE Adverse Event Report: ZIMMER GMBH CMN FEMORAL NAIL, CCD 130, RIGHT, 10 MM, 36 CM; ZIMMER NATURAL NAIL SYSTEM CEPHALOMEDULLARY NAILS

Model Number N/A

Device Problem Insufficient Information (3190)

Patient Problem Ambulation Difficulties (2544)

Event Type  Injury  

Manufacturer Narrative

The manufacturer did not receive devices for review as the patient has not been revised.Where lot numbers were received for the devices, 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.Zimmer¿s reference number of this file is cmp-(b)(4).

Event Description

It was reported that the patient was implanted a cmn femoral nail, ccd 130, right, 10 mm, 36 cm on (b)(6) 2016 on the right side and is experiencing ambulation difficulties eight weeks after revision of femoral nail.Additional information has been requested and is currently not available.(same patient is treated in cmp-(b)(4), revision due to nail breakage.).

Manufacturer Narrative

Trend analysis: no trend identified.Device history records (dhr): the device manufacturing quality records indicate that the released components met all requirements to perform as intended.Event summary: it was reported that the patient initially had a znn nail breakage which was revised on (b)(6) 2016 (reported under (b)(4)).A new znn nail was implanted on (b)(6) 2016.In the e-mail received from the patient on (b)(6) 2016 it states that the patient is still going through a lot.In another mail received on november 04, 2016 she is describing that 8 weeks after the new znn nail was implanted (on (b)(6) 2016) she still have 3 weeks to go without putting any weight on her leg.A specific event description was not provided.Review of received data: no medical data such as x-rays, surgical notes or any other case-relevant documents received for the new znn nail which was implanted on (b)(6) 2016.Devices analysis: no product was returned to zimmer biomet for in-depth analysis.Review of product documentation: the compatibility check was performed and showed that the product combination was approved by zimmer biomet.Root cause analysis: the reported event cannot be related to a specific failure mode.Conclusion summary: the patient initially had a znn nail breakage which was revised on (b)(6) 2016 and a new znn nail was implanted.In the mail received from the patient on (b)(6) 2016 it states that the patient is still going through a lot.No further information received about the event.No devices were returned.No further statement can be done.Based on the given information and the results of the investigation, the complaint could not be confirmed as the alleged failure could not be identified or reproduced.The need for further corrective measures is not indicated and zimmer (b)(4) considers this case as closed.(b)(4).

• Brand Name: CMN FEMORAL NAIL, CCD 130, RIGHT, 10 MM, 36 CM
• Type of Device: ZIMMER NATURAL NAIL SYSTEM CEPHALOMEDULLARY NAILS
• Manufacturer (Section D): ZIMMER GMBH; sulzer allee 8; sulzer industrie park; winterthur 8404 ; SZ 8404
• Manufacturer (Section G): ZIMMER GMBH; sulzer allee 8; sulzer industrie park; winterthur 8404 ; SZ 8404
• Manufacturer Contact: kevin escapule ; 1800 west center street; warsaw, IN 46580 ; 8006136131
• MDR Report Key: 6180652
• MDR Text Key: 62546047
• Report Number: 0009613350-2016-01451
• Device Sequence Number: 1
• Product Code: HSB
• Combination Product (y/n): N
• Reporter Country Code: CA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,foreign
• Reporter Occupation: Patient
• Type of Report: Initial,Followup
• Report Date: 11/17/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/16/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Expiration Date: 01/31/2023
• Device Model Number: N/A
• Device Catalogue Number: 47-2493-362-10
• Device Lot Number: 2693082
• Other Device ID Number: 00889024299672
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/21/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/25/2013
• 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
• Patient Outcome(s): Other