MAUDE Adverse Event Report: ZIMMER GMBH ZNN CMN NAIL TRAUMA IMPLANT

Model Number N/A

Device Problem Positioning Problem (3009)

Patient Problem No Information (3190)

Event Type  Injury  

Manufacturer Narrative

The manufacturer did not receive x-rays, or other source documents for review.The manufacturer did not receive the device for 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 supplemental information becomes available an updated report will be submitted.Additional information has been requested and is currently not available.Zimmer biomet¿s reference number of this file is (b)(4).

Event Description

It was reported that the patient was implanted an unknown znn cmn nail trauma implant(catalogue number unknown) on an unknown side (exact date not reported).Currently, the patient is being monitored due to cut-out of lag screw.

Manufacturer Narrative

As the case at hand was taken from a journal article it is not suspected that the device or additional information is being submitted for review.A technical investigation was not possible to perform, as the devices were not at hand for investigation.However, based on the available information the investigation is conducted with outcome as follows.As no lot numbers were provided for the devices, the device history records could not be reviewed.At zimmer gmbh 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 gmbh 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.Event summary: it is reported in a journal article that a patient who was implanted with a znn nail system experienced cutout due to an incorrect positioning of the cephalic screw.Revision surgery or other treatment is not further mentioned.Review of received data: no medical data such as x-rays, surgical notes or any other case-relevant documents received devices analysis: no product was returned to zimmer biomet for in-depth analysis.Root cause analysis: root cause determination using sap rmw.Lag screw migration due to incorrect lag screw design results in cut out.=> not possible.A systematic issue with design and/or material properties would have been detected as part of the issue evaluation assessment.Failure of surgery due to use of the device not compliant with defined indications.=> possible.The fracture classification described in the method section of the journal article: ¿a proximal femoral fracture (a3, b1, or b2 according to the ota/ao fracture classification)¿ and ¿basicervical peritrochanteric fracture of the proximal part of the femur¿ does not allow to certainly determine if the znn nail was implanted according or against the indications described in the surgical technique.Failure of surgery due to wrong selection of components or use in combination with device outside the znn cmn system.=> possible.As no product identification numbers were provided, it cannot be excluded, that the zimmer biomet components were combined with competitors products.Lag screw migration due to users determine wrong lag screw length.=> possible.As no x-rays or item reference numbers were provided, it can not be excluded, that the user chose the wrong lag screw length.Lag screw migration due to users apply set screw not correctly (lag screw groove not engaged).=> possible.It cannot be excluded, that the surgeon applied the set screw incorrectly.Failure of surgery due to missing/incomplete information available, misleading information of surgical technique and/or instructions for use.=> not possible.Surgical approach, indications and contraindications are described in the surgical technique.Surgical technique or instruction for use are not questioned.- unreadable information on labeling => not possible.Labeling is not questioned.Conclusion summary: in the journal article is mentioned, that the screw cut out due to wrong positioning.Therefore wrong surgical approach can be assumed as the most probable root cause.Neither x-rays, 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 affected implants were not received for investigation; therefore the condition of the components is unknown.No surgical report of implantation or intra operative x-rays were sent.The only information which is available is what was given in the journal article.In conclusion, 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 gmbh considers this case as closed.Zimmer¿s reference number of this file is (b)(4).

• Brand Name: ZNN CMN NAIL TRAUMA IMPLANT
• Type of Device: ZNN CMN NAIL
• 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: christina arnt ; 56 e. bell dr.; warsaw, IN 46582 ; 5745273773
• MDR Report Key: 6656127
• MDR Text Key: 78015252
• Report Number: 0009613350-2017-00869
• Device Sequence Number: 1
• Product Code: HSB
• Combination Product (y/n): N
• Reporter Country Code: IT
• PMA/PMN Number: PN/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,literature
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 06/21/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/21/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: N/A
• Device Catalogue Number: UNKNOWN
• Device Lot Number: UNKNOWN
• Other Device ID Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/08/2017
• 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 Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Other