• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER SWITZERLAND MANUFACTURING GMBH CMN FEMORAL NAIL, CCD 130, RIGHT, 13 MM, 21.5 CM; ZIMMER NATURAL NAIL SYSTEM CEPHALOMEDULLARY NAILS

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

ZIMMER SWITZERLAND MANUFACTURING GMBH CMN FEMORAL NAIL, CCD 130, RIGHT, 13 MM, 21.5 CM; ZIMMER NATURAL NAIL SYSTEM CEPHALOMEDULLARY NAILS Back to Search Results
Model Number N/A
Device Problems Fracture (1260); Material Integrity Problem (2978)
Patient Problem Failure of Implant (1924)
Event Date 12/27/2020
Event Type  Injury  
Manufacturer Narrative
The manufacturer did receive per for review.The manufacturer did not receive the device for investigation.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.As soon as supplemental information becomes available an updated report will be submitted.(b)(4).
 
Event Description
Patient was implanted on the unknown side and underwent revision surgery due to implant fracture.
 
Manufacturer Narrative
Event description: it was reported that the patient was implanted with a znn nail in the right femur on (b)(6) 2020.When the patient visited the hospital on (b)(6) 2020 it was noticed from the x-ray that the implant had fractured.Subsequently, the patient underwent revision surgery on (b)(6) 2020.Review of received data: due diligence: no further due diligence required as all required information to support the conclusion is available or was already requested.X-rays: an undated radiograph of the right hip and proximal thigh was presented.The radiograph was photographed from a computer screen and is of poor image quality due to light reflection.It can be seen that the axis of the proximal nail part (above the lag screw) is slightly out of line with the nail axis.Patient data: patient information was not provided due to patient privacy policy.Product evaluation: the product was not returned by the hospital; therefore, visual and dimensional evaluation could not be performed.Review of product documentation: device purpose: this device is intended for treatment.Product compatibility: the product combination was approved by zimmer biomet.Dhr review: review of the device history records identified no deviations or anomalies during manufacturing.Conclusion: it was reported that the patient was implanted with a znn nail in the right femur on (b)(6) 2020.When the patient visited the hospital on (b)(6) 2020 it was noticed from the x-ray that the implant had fractured.Subsequently, the patient underwent revision surgery on (b)(6) 2020.The quality records show that all specified characteristics have met the specifications valid at the time of production.Therefore, the investigation did not identify a nonconformance or a complaint out of box (coob).Based on the radiograph provided, the reported nail fracture can be confirmed.However, due to the unavailability of the reported device and the lack of medical data, the exact cause cannot be determined.The need for corrective measures is not indicated and zimmer switzerland manufacturing gmbh considers this case as closed.Zimmer biomet¿s reference number of this file is (b)(4).
 
Event Description
No change to previously reported event.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
CMN FEMORAL NAIL, CCD 130, RIGHT, 13 MM, 21.5 CM
Type of Device
ZIMMER NATURAL NAIL SYSTEM CEPHALOMEDULLARY NAILS
Manufacturer (Section D)
ZIMMER SWITZERLAND MANUFACTURING GMBH
sulzer allee 8
sulzer industrie park
winterthur 8404
SZ  8404
MDR Report Key11162728
MDR Text Key226542101
Report Number0009613350-2021-00010
Device Sequence Number1
Product Code HSB
UDI-Device Identifier00889024298934
UDI-Public00889024298934
Combination Product (y/n)N
PMA/PMN Number
K091566
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Type of Report Initial,Followup
Report Date 09/27/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/13/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Lay User/Patient
Device Model NumberN/A
Device Catalogue Number47-2493-212-13
Device Lot Number2869577
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Date Manufacturer Received09/20/2021
Is This a Reprocessed and Reused Single-Use Device? No
Removal/Correction NumberN/A
Patient Sequence Number1
Patient Outcome(s) Hospitalization; Required Intervention;
-
-