MAUDE Adverse Event Report: ZIMMER GMBH ZNN, CMN LAG SCREW, 10.5 MM, 110 MM INCLUDING SET SCREW ZIMMER NATURAL NAIL SYSTEM CEPHALOMEDULLARY NAILS

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).

• Brand Name: ZNN, CMN LAG SCREW, 10.5 MM, 110 MM INCLUDING SET SCREW
• Type of Device: ZIMMER 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 Key: 6176510
• Report Number: 0009613350-2016-01438
• Device Sequence Number: 1
• Product Code: HSB
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• 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 Received: 12/15/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes

Device Operator

• Device Expiration Date: 09/30/2020
• Device Model Number: N/A
• Device Catalogue Number: 47-2485-110-10
• Device Lot Number: 2828302
• Other Device ID Number: N/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 Received: 02/21/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/18/2015
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: N/A
• Patient Outcome(s): Hospitalization; Required Intervention