MAUDE Adverse Event Report: ZIMMER MANUFACTURING SWITZERLAND GMBH ZNN, CMN LAG SCREW, 10.5 MM, 115 MM INCLUDING SET SCREW; TRAUMA PROTHESIS

Model Number	N/A
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	Nonunion/Delayed-union Bone Fracture (2369)
Date of Event	06/16/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the fracture on the right hip failed to heal.About 1,5 months after the implantation, the patient underwent revision surgery.Due diligence is in progress for this complaint; to date no additional information or product has been received.
Additional Manufacturer Narrative
(b)(4).Concomitant medical devices: cmn femoral nail, ccd 125, right, 10 mm, 21.5 cm , item # 47249321010 , lot # 3076204.5.0 mm diameter cortical screw - red fixed angle 3.5 mm hex head , item # 47248403550 , lot # 64079925.Set screw, 8 mm, 21 mm, hex 3.5 mm , item# 47249300000 , lot# 1643922n.Multiple mdr reports were filed for this event, please see associated reports: 0009613350 - 2022 - 00361.The device will not be returned for analysis; however, an investigation of the reported event is in progress.Once the investigation is completed, a supplemental medwatch 3500a will be submitted.
Additional Manufacturer Narrative
(b)(4).This follow-up report is being submitted to relay additional and/or corrected information.No product was returned for evaluation.However, the provided pictures identified loosening of the femoral neck screw and migration toward the acetabular wall.Review of the device history record(s) identified no deviations or anomalies during manufacturing.Devices are used for treatment.It was reported that the fracture on the right hip failed to heal 1.5 months post surgery.Loosening and migration of the hip screw, together with marked osteopenia of the patient are potential contributing factors.However, as product was not returned and further information was not provided, a definitive root cause cannot be determined.If any further information is found which would change or alter any conclusions or information, a supplemental report will be filed accordingly.Zimmer biomet will continue to monitor for trends.
Event or Problem Description
No further event information available at the time of this report.
Additional Manufacturer Narrative
(b)(4).This follow-up report is being submitted to relay additional and/or corrected information.All the products were returned for investigation.Visual and functional examination were performed.It was reported that the fracture on the right hip failed to heal after 1.5 months from surgery.Surgery notes were provided.It was reported that: the case took approximately 4 times longer than normal secondary to the patient's morbid obesity.The sheer volume of soft tissue between the skin and the bone made it difficult to place the starting guide pin past the nail due to soft tissue impingement on the guide and past the guide pin for the lag screw.Additionally, positioning took twice as normal secondary to patient's morbid obesity (bmi 54).Medical radiography was provided and reviewed by a healthcare professional.A review of the available radiography identified the following: malalignment of the ununited femoral neck fracture and displacement of the loosened hip screw, the femoral neck screw is loose and migrated through the medial wall of the acetabulum: the marked osteopenia, screw displacement, and fracture varus alignment could all contribute to fracture non-union.Products were returned for investigation; visual and functional examination were performed.On the nail, the holes where the lag screw and the setting screw are placed shows scratches and polished areas.The lag screw as well, shows signs of wearing on the surface.These damages are most likely due to the explanation procedure during revision surgery.The setting screw could reach the end of the tread without any issue and block the lag screw as intended; therefore, functionality of the system seems not to be impaired.As per medical report, the patient showed marked osteopenia which might also have contributed to the reported event.With the available information a definitive root cause cannot be determined.If any further information is found which would change or alter any conclusions or information, a supplemental report will be filed accordingly.Zimmer biomet will continue to monitor for trends.
Event or Problem Description
No further event information available at the time of this report.

• Brand Name: ZNN, CMN LAG SCREW, 10.5 MM, 115 MM INCLUDING SET SCREW
• Common Device Name: TRAUMA PROTHESIS
• Manufacturer (Section D): ZIMMER MANUFACTURING SWITZERLAND GMBH; sulzer allee 8; sulzer industrie park; winterthur 8404 ; SZ 8404
• Manufacturer (Section G): ZIMMER MANUFACTURING SWITZERLAND 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: 14998933
• Report Number: 0009613350-2022-00360
• Device Sequence Number: 1674355
• Product Code: HSB
• UDI-Device Identifier: 00889024298484
• UDI-Public: (01)00889024298484(17)230228(10)2941276
• Combination Product (Y/N): N
• Initial Reporter State: NM
• Initial Reporter Country: US
• PMA/510(K) Number: N/A
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/10/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Lay User/Patient
• Device Expiration Date: 02/28/2023
• Device Model Number: N/A
• Device Catalogue Number: 47-2485-115-10
• Device Lot Number: 2941276
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/16/2022
• Supplement Date Received by Manufacturer: 09/08/2022; 09/28/2022
• Initial Report FDA Received Date: 07/13/2022
• Supplement Report FDA Received Date: 09/13/2022; 10/11/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/05/2018
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: N/A
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Sex: Male
• Patient Weight: 161 KG