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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER GMBH CMN FEMORAL NAIL, CCD 130, RIGHT, 11.5 MM, 34 CM ZIMMER NATURAL NAIL SYSTEM CEPHALOMEDULLARY NAILS

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ZIMMER GMBH CMN FEMORAL NAIL, CCD 130, RIGHT, 11.5 MM, 34 CM ZIMMER NATURAL NAIL SYSTEM CEPHALOMEDULLARY NAILS Back to Search Results
Model Number N/A
Device Problem Break (1069)
Patient Problems Failure of Implant (1924); Injury (2348)
Event Date 08/04/2016
Event Type  Injury  
Manufacturer Narrative
The manufacturer did not yet receive the device for investigation. However it is mentioned by the complainant, that it will be provided for investigation. Surgical reports were not provided for review. X-rays were received and will be reviewed as part of ongoing investigation. As no lot number was provided, the device history records could not be reviewed. A cause for this specific event cannot be ascertained from the information provided. As soon as additional information become available and/or an investigation result be available, an amended medical device report will be submitted. (b)(4).
 
Event Description
It was reported that a patient was implanted with a cmn femoral nail, ccd 130, right, 11. 5 mm, 34 cm end of (b)(6) 2016 (exact date unknown) and had to be revised due to nail breakage on (b)(6) 2016. Note: as exact implantation date is unknown the last day of the month reported is taken in this report.
 
Manufacturer Narrative
As no lot numbers were provided for the devices, the device history records could not be reviewed. An e-mail requesting missing device data information was sent on (b)(6) 2016. At zimmer (b)(4) all medical devices prior release to market undergo several quality inspections as defined in our quality procedures. Our quality inspection- and deviation procedures ensure that only products fulfilling the specification are sold. These procedures are part of the overall quality management system at zimmer (b)(4) and get regularly audited by our notified body, competent authorities and internal and external auditors. Thus, for all products sold to the market can be assumed having a complete and correct dhr. Trend analysis: no trend identified. A trend is identified if at least one of the following criteria is met: 3 similar events within 1 month for the same item number; 6 similar events within 6 months for the same item number; 2 similar events for the same lot number. Event summary: it was reported that a znn nail was implanted on (b)(6) 2016 and revised on (b)(6) 2016 due to a breakage. Review of received data: two x-rays were received. Both x-rays are undated. On one x-ray the broken znn nail can be seen. The breakage is located through the hole for the lag screw. The nail was also fixed with a cable. On the other x-ray a dynamic hip screw can be seen. No information was provided about these components, the manufacturer is unknown. It is also unknown if the hip screw was implanted prior or after the znn nailing system. Review of product documentation: the compatibility check was performed from surgical technique and showed that the product combination was approved by zimmer biomet. Neither operative notes, office visit notes, nor devices or photos of the explanted implants were received; therefore the condition of the components is unknown. Patient factors that may affect the performance of the components such as bone quality, activity level, type of activity (low impact vs. High impact), and relevant medical history are unknown. Adherence to rehabilitation protocol is unknown. The received x-ray do only show that the breakage is located on the lag screw hole and that a cable was used to fix the nail. In conclusion, due to significant lack of information, it is impossible to perform a meaningful analysis of the reported event. An exact root cause for the breakage could not be determined. The need for corrective actions is not indicated and zimmer (b)(4) considers this case as closed. Zimmer's reference number of this file is cmp-(b)(4).
 
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Brand NameCMN FEMORAL NAIL, CCD 130, RIGHT, 11.5 MM, 34 CM
Type of DeviceZIMMER 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 Key6111918
MDR Text Key60280320
Report Number0009613350-2016-01361
Device Sequence Number1
Product Code HSB
Combination Product (y/n)N
Reporter Country CodeFR
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional
Reporter Occupation
Type of Report Initial,Followup
Report Date 10/26/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/18/2016
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberN/A
Device Catalogue Number47-2493-342-11
Other Device ID Number00889024299504
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received02/01/2017
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Removal/Correction NumberN/A

Patient Treatment Data
Date Received: 11/18/2016 Patient Sequence Number: 1
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