MAUDE Adverse Event Report: ZIMMER SWITZERLAND MANUFACTURING GMBH Z NAIL CMF 10.5 X 95 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); Appropriate Term/Code Not Available (3191)

Patient Problems Failure of Implant (1924); Insufficient Information (4580)

Event Date 01/21/2022

Event Type  Injury  

Event Description

It was reported that the patient underwent revision surgery due to migration of the implant.

Manufacturer Narrative

This product is manufactured by zimmer biomet( b)(4) and is not cleared or distributed in the (b)(4) however, this report is being submitted as zimmer biomet (b)(4) manufactures a similar device that is cleared or distributed in the (b)(4).X-rays, photographs, were received and will be reviewed as part of ongoing investigation.The manufacturer did not receive the device yet, however it is indicated by complainant that it will be returned 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).Multiple mdr reports were filed for this event, please see associated reports: 0009613350-2022 -00112.

Event Description

No change to previously reported event.

Manufacturer Narrative

This follow-up report is being submitted to relay additional and/or corrected information.Event description: it was reported, that: operation was performed with cm fortis nail system on (b)(6) 2021.After the initial operation, surgeon confirmed x-rays and he found the lag screw was sliding to outer side.Therefore, revision surgery was conducted on jan 21, 2022, and all implants implanted in the initial surgery were explanted.No delay.Patient outcome: revision due to migration.Review of received data: due diligence: no further due diligence required as all required information to support the conclusion is available or was already requested.X-rays: some x-ray pictures were received for investigation.Assuming that the order of the x-rays is chronologically it can be seen that there is a migration of the telescopic lag screw.Images: several images were received of the device.However since the device was received as well the images were not further investigated.Product evaluation: visual examination: all revised components were received for investigation.The tls show wear marks on the outer as well as on the inner sleeve on one side.The wear marks consist of small abrasions.In another area long coarse scratches can be observed on the outer sleeve.The thread of the tls also shows some polishing.The nail show wear marks most likely by the drill on the inside of the bore hole.The screws do not show any damaged or deformed area.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 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: operation was performed with cm fortis nail system on (b)(6) 2021.After the initial operation, surgeon confirmed x-rays and he found the lag screw was sliding to outer side.Therefore, revision surgery was conducted on jan 21, 2022, and all implants implanted in the initial surgery were explanted.No delay.Patient outcome: revision due to 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.Based on the received x-rays a migration of the telescopic lag screw can be confirmed.All revised components were received for investigation.The tls and the nail show wear marks and scratches consistent with the migration.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.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).

• Brand Name: Z NAIL CMF 10.5 X 95 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: 13599275
• MDR Text Key: 286496726
• Report Number: 0009613350-2022-00113
• 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: 05/24/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/25/2022
• 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: 47-2499-095-10
• Device Lot Number: 3075458
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/20/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/24/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Sex: Female