MAUDE Adverse Event Report: ZIMMER SWITZERLAND MANUFACTURING GMBH Z NAIL CMF 10.5 X 80 LAG SCR; TRAUMA PROSTHESIS

Model Number N/A

Device Problems Migration or Expulsion of Device (1395); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/11/2021

Event Type  Injury  

Event Description

It was reported that the initial operation was performed with cmf nail system.After 2 weeks from the initial, surgeon confirmed x-rays and he found the lag screw was sliding to outer side.The surgeon keep an eye on the patient condition as well as no revision will be planned so far.

Manufacturer Narrative

This product is manufactured by zimmer biomet (b)(4) and is not cleared or distributed in the u.S.However, this report is being submitted as zimmer biomet (b)(4) manufactures a similar device that is cleared or distributed in the united states.The manufacturer did not receive x-rays, or other source documents for review.The manufacturer did not receive the device for investigation.The lot number of the device was received.The device history records will be reviewed during investigation.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.Zimmer biomet¿s reference number of this file is (b)(4).Remains implanted.

Manufacturer Narrative

This product is manufactured by zimmer biomet (b)(4) and is not cleared or distributed in the u.S.However, this report is being submitted as zimmer biomet (b)(4) manufactures a similar device that is cleared or distributed in the united states.The manufacturer did not receive x-rays, or other source documents for review.The manufacturer did not receive the device for investigation.The lot number of the device was received.The device history records will be reviewed during investigation.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.Zimmer biomet¿s reference number of this file is (b)(4).Remains implanted.

Event Description

It was reported that the initial operation was performed with cmf nail system.After 2 weeks from the initial, surgeon confirmed x-rays and he found the lag screw was sliding to outer side.The surgeon keep an eye on the patient condition as well as no revision will be planned so far.

Manufacturer Narrative

This follow-up report is being submitted to relay additional and/or corrected information.Event description: it was reported, that: initial operation was performed with cmf nail system on (b)(6) 2021.After 2 weeks from the initial, surgeon confirmed x-rays and he found the lag screw was sliding to outer side.The surgeon keep an eye on the patient condition as well as no revision will be planned so far.No delay.Patient outcome: migration.Review of received data: - no medical data (like surgical reports or x-rays) relevant to the case has been received.- due diligence: no further due diligence required as all required information to support the conclusion is available or was already requested.Product evaluation: - no product was returned; therefore, visual and dimensional evaluation could not be performed.Review of product documentation: - device purpose: all involved devices are intended for treatment.- product compatibility: the product combination was approved by zimmer biomet.- dhr review: review of the device history records identified no deviations or anomalies during manufacturing.- surgical technique sap: the correct implantation and insertion (tls placement and set screw locking) is described in the surgical technique.Please also note the following section regarding set screw locking: after the tls is placed, the pre-assembled setscrew in the nail must be tightened with the torque limiting handle offered with the system, to prevent the tls sleeve from moving post-operatively.An anterior support screw can be placed in addition to the tls to provide rotational stability and support the treatment of unstable intertrochanteric fractures with large posteromedial (lesser trochanter) and posterolateral (greater trochanter) fragments, preventing excessive lag screw sliding post-operation.- complaint history review: review of complaint history identified no additional similar complaints for the reported item and no additional complaints for the reported part and lot combination related to the event.Conclusion: it was reported, that: initial operation was performed with cmf nail system on (b)(6) 2021.After 2 weeks from the initial, surgeon confirmed x-rays and he found the lag screw was sliding to outer side.The surgeon keep an eye on the patient condition as well as no revision will be planned so far.No delay.Patient outcome: migration.The quality records show that all specified characteristics (material, dimensions, surface, etc.) for the affected products have met the specifications valid at the time of production.No product was returned, hence visual and dimensional evaluation could not be performed; therefore, the condition of the parts is unknown.However, the received x-rays confirm that the as2 and the tls were backed out post-operatively.Based on the available information it is not possible to determine the root cause for this issue.A further and more comprehensive investigation is undergoing to determine the necessity of potential corrective and/or preventive actions.According to the current available information, there are no confirmed product nonconformity related to the issue.There are also no known design or manufacturing related issue to the znn cm fortis nails and lag screws at this time.A possible contributing factor for the migration could be a malreduction or a really unstable fracture.By considering these factors and the corresponding use of the system, good results can be expected even in this demanding situations.This is also confirmed by an hcp review.It is also mentioned that a minor backout of the tls is not a clinical issue.The need for corrective measures is not indicated and zimmer switzerland manufacturing gmbh considers this case as closed.Zimmer biomet¿s reference number of this file is (b)(4).

Event Description

No change to previously reported event.

• Brand Name: Z NAIL CMF 10.5 X 80 LAG SCR
• Type of Device: TRAUMA PROSTHESIS
• Manufacturer (Section D): ZIMMER SWITZERLAND MANUFACTURING GMBH; sulzer allee 8; sulzer industrie park; winterthur 8404 ; SZ 8404
• Manufacturer (Section G): ZIMMER SWITZERLAND MANUFACTURING 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: 13496743
• MDR Text Key: 285333271
• Report Number: 0009613350-2022-00065
• Device Sequence Number: 1
• Product Code: HSB
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: N/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 04/12/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/09/2022
• 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: 47-2499-080-10
• Device Lot Number: 3070480
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/17/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/15/2021
• 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): Hospitalization