MAUDE Adverse Event Report: ZIMMER SWITZERLAND MANUFACTURING GMBH Z NAIL CMF 10.5 X 105 LAG SCR; N/A

Model Number N/A

Device Problem Patient Device Interaction Problem (4001)

Patient Problem Insufficient Information (4580)

Event Date 08/28/2021

Event Type  malfunction  

Manufacturer Narrative

Concomitant medical products: item# 47248403050, lot# 64581091, 5.0 mm diameter cortical screw - red fixed angle 3.5 mm hex head.Item# 47250000200, lot# 3056979, z nail cmf nail cap 0mm.Item# 47250107550, lot# 3050714, z nail cmf 5.0x75 ant sup scr.Event description: it was reported that the patient received an implant on (b)(6) 2021.After 3 months from the initial surgery, the surgeon found the lag screw migrated on the radiographical follow-up.The patient is being monitored, but no revision surgery has been planned so far.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.No medical records have been received.Product evaluation: the devices remain implanted.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 relevant deviations or anomalies during manufacturing.Surgical technique: 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.Conclusion: it was reported that the patient received an implant on (b)(6) 2021.After 3 months from the initial surgery, the surgeon found the lag screw migrated on the radiographical follow-up.The patient is being monitored, but no revision surgery has been planned so far.The quality records show that all specified characteristics have met the specifications valid at the time of production.Therefore, the investigation did not identify a nonconformance or a complaint out of box (coob).No product was returned, hence visual and dimensional evaluation could not be performed; therefore, the condition of the parts is unknown.Further, medical records such as x-rays and implantation/revision reports have not been received, therefore, the reported migration cannot be confirmed.Nevertheless, due to similar events a further and more comprehensive investigation (ie-19393) was initiated 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 (b)(4) considers this case as closed.Zimmer biomet¿s reference number of this file is (b)(4).

Event Description

It was reported that a patients lag screw was sliding to outer side.The surgeon keeps an eye on the patient condition as well as no revision is planned so far.

• Brand Name: Z NAIL CMF 10.5 X 105 LAG SCR
• Type of Device: N/A
• 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: 12867003
• MDR Text Key: 282383211
• Report Number: 0009613350-2021-00605
• 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
• Report Date: 11/24/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/24/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: N/A
• Device Catalogue Number: 47-249-9105-10
• Device Lot Number: 3056677
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/22/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/23/2020
• 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; Required Intervention
• Patient Sex: Female