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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, 110 MM INCLUDING SET SCREW ZIMMER NATURAL NAIL SYSTEM CEPHALOMEDULLARY NAILS

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ZIMMER GMBH ZNN, CMN LAG SCREW, 10.5 MM, 110 MM INCLUDING SET SCREW ZIMMER NATURAL NAIL SYSTEM CEPHALOMEDULLARY NAILS Back to Search Results
Model Number N/A
Device Problem Positioning Problem (3009)
Patient Problem No Information (3190)
Event Date 11/16/2016
Event Type  Injury  
Manufacturer Narrative
The manufacturer did not receive devices, x-rays, or other source documents for review. 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, 110 mm including set screw on (b)(6) 2016. Subsequently, the patient was revised due to znn nail cut out of the head on (b)(6) 2016.
 
Manufacturer Narrative
Updates: initial reporter, date received by mfr, type of reports, if follow-up, what type?, additional mfr narrative. The manufacturer did not receive devices, x-rays, or other source documents for review. Product is not available as it was discarded. 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. (b)(4).
 
Manufacturer Narrative
Investigation results were made available. Device history records (dhr): the device manufacturing quality records indicate that the released components met all requirements to perform as intended. Trend analysis: no trend identified. Review of event description: it was reported that a patient underwent an initial hip procedure on (b)(6) 2016. Subsequently, the patient was revised due to znn nail cut out of the head on (b)(6) 2016. The znn nail was removed. Review of received data; no medical data such as x-rays, surgical notes or any other case-relevant documents received. Additional information has been requested but was not provided. Devices analysis; no product was returned to zimmer biomet for in-depth analysis. It was mentioned that the devices were discarded. Review of product documentation: the compatibility check was performed from surgical technique and showed that the product combination was approved by zimmer (b)(6). The surgical technique describes that a set screw (included in the lag screw package or packaged separately) must be used to prevent the lag screw from rotating post-operatively. Root cause determination using rmw: implant migration due to mri interacts with titan implant components.
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>not possible -> no information received for mri. Lag screw migration due to incorrect lag screw design results into cut out.
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>not possible -> a systematic issue with design and/or material properties would have been detected as part of a trend review defined in complaint registration, systematic assessment defined in complaint investigation wtor in the current pms process. Failure of surgery due to use of the device not compliant with defined indications.
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> possible, no surgical information provided. Failure of surgery due to wrong selection of components or use in combination with device outside the znn cmn system.
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> possible, no surgical information provided. Lag screw migration due to users determine wrong lag screw length.
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> possible, no x-rays received. Lag screw migration due to users apply set screw not correctly (lag screw groove not engaged).
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> possible, no surgical reports or x-rays received. Failure of surgery due to missing/incomplete information available, misleading information of surgical technique and/or instructions for use.
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> possible, no surgical reports or x-rays received. Conclusion summary: neither x-rays, operative notes, office visit notes, nor devices or photos of the explanted implant(s) were received; therefore the condition of the component(s) 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 surgical technique describes the correct implantation of the znn nailing system. 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 corrective measures is not indicated and zimmer (b)(4) considers this case as closed. Zimmer¿s reference number of this file is (b)(4).
 
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Brand NameZNN, CMN LAG SCREW, 10.5 MM, 110 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 Key6176510
MDR Text Key62435319
Report Number0009613350-2016-01438
Device Sequence Number1
Product Code HSB
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 11/21/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/15/2016
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date09/30/2020
Device Model NumberN/A
Device Catalogue Number47-2485-110-10
Device Lot Number2828302
Other Device ID NumberN/A
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 Received02/21/2017
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured09/18/2015
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: 12/15/2016 Patient Sequence Number: 1
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