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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ZIMMER GMBH ZNN, CMN LAG SCREW, 10.5 MM, 95 MM, INCLUDING SET SCREW ZIMMER NATURAL NAIL SYSTEM CEPHALOMEDULLARY NAILS

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ZIMMER GMBH ZNN, CMN LAG SCREW, 10.5 MM, 95 MM, INCLUDING SET SCREW ZIMMER NATURAL NAIL SYSTEM CEPHALOMEDULLARY NAILS Back to Search Results
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 (b)(4).
 
Event Description
It was reported that the patient was implanted a znn, cmn lag screw, 10. 5 mm, 95 mm, including set screw 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 (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 october 29, 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 october 29, 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. Zimmer reference number of this file is (b)(4).
 
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Brand NameZNN, CMN LAG SCREW, 10.5 MM, 95 MM, INCLUDING SET SCREW
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 Key6180667
MDR Text Key62598645
Report Number0009613350-2016-01453
Device Sequence Number1
Product Code HSB
Combination Product (y/n)N
Reporter Country CodeCA
Number of Events Reported1
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 Received12/16/2016
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date01/31/2021
Device Model NumberN/A
Device Catalogue Number47-2485-095-10
Device Lot Number2844483
Other Device ID Number00889024298446
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received02/21/2017
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured01/25/2016
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: 12/16/2016 Patient Sequence Number: 1
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