• 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, 11.5 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, 11.5 MM, 21.5 CM ZIMMER NATURAL NAIL SYSTEM CEPHALOMEDULLARY NAILS Back to Search Results
Model Number N/A
Device Problem Material Integrity Problem (2978)
Patient Problem Failure of Implant (1924)
Event Date 03/26/2021
Event Type  Injury  
Manufacturer Narrative
Concomitant medical products item# 47248510510, lot# 3026107, znn, cmn lag screw, 10. 5 mm, 105 mm including set screw. Item# 47248403550, lot# 64850532, 5. 0 mm diameter cortical screw - red fixed angle 3. 5 mm hex head. Event description: it was reported that the patient was implanted on an unknown date and underwent a revision surgery on (b)(6) 2021 due to implant fracture. 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: x-ray was reviewed by a radiologist. There is a comminuted femoral neck fracture with femoral nail and screw fixation. The femoral nail is fractured at the screw level with varus angulation at the nail fracture site. The screw is intact. The distal aspect of the nail is not included on the image. Images: review of the received images shows that the nail was broken through the hole for the lag screw. Based on the images the nature of the fracture cannot be evaluated. Surgical report: there is an implant surgery sheet and an explant surgery sheet available with some information like product ref and lot numbers. No other relevant information is available. Product evaluation: no product was returned; therefore, visual and dimensional evaluation could not be performed. Review of product documentation: device purpose: all involved devices are intended for treatment. Product compatibility: the compatibility check was performed from www. Productcompatibility. Zimmer. Com and showed that the product combination was approved by zimmer biomet. Dhr review: review of the device history records identified no deviations or anomalies during manufacturing. Raw material certificate: the raw material certificate was reviewed with no anomalies noted. Conclusion: it was reported that the patient was implanted on an unknown date and underwent a revision surgery on (b)(6) 2021 due to implant fracture. The quality records show that all specified characteristics (material, dimensions, surface, etc. ) for the znn nail have met the specifications valid at the time of production. No product was returned; therefore, visual and dimensional evaluation could not be performed. The implant date of the znn nailing system is unknown. Therefore, it cannot be said how long the nail was in vivo. The removal was on (b)(6) 2021. Review of the received images shows that the nail was broken through the hole for the lag screw. Review of the received images shows that the nail was broken through the hole for the lag screw. However, based on the images the nature of the fracture cannot be evaluated. It is possible that the nail was fractured due to fatigue which can occur due to a cyclic overloading. Possible contributing factors to the overload could be a not properly healed bone fracture and / or not adherence to the postoperative protocol (patient behavior). However, based on the available information and performed investigation, an exact root cause for the nail breakage could not be determined. The investigation results did not identify a non-conformance or a complaint out of box (coob).
 
Event Description
It was reported that patient underwent revision surgery due to implant fracture.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameCMN FEMORAL NAIL, CCD 130, RIGHT, 11.5 MM, 21.5 CM
Type of DeviceZIMMER NATURAL NAIL SYSTEM CEPHALOMEDULLARY NAILS
Manufacturer (Section D)
ZIMMER SWITZERLAND MANUFACTURING GMBH
sulzer allee 8
sulzer industrie park
winterthur 8404
SZ 8404
Manufacturer (Section G)
ZIMMER SWITZERLAND MANUFACTURING GMBH
sulzer allee 8
sulzer industrie park
winterthur 8404
SZ 8404
Manufacturer Contact
christina arnt
56 e. bell dr.
warsaw, IN 46582
5745273773
MDR Report Key12237117
MDR Text Key263829252
Report Number0009613350-2021-00352
Device Sequence Number1
Product Code HSB
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K091566
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Reporter Occupation
Type of Report Initial
Report Date 07/28/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/28/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberN/A
Device Catalogue Number47-2493-212-11
Device Lot Number2973566
Was Device Available for Evaluation? No Answer Provided
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received07/23/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured11/13/2018
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage
Removal/Correction NumberN/A

Patient Treatment Data
Date Received: 07/28/2021 Patient Sequence Number: 1
-
-