MAUDE Adverse Event Report: VIANT MEDICAL, LLC EZ CLEAN REAMER HANDLE; STRAIGHT REAMER HANDLE

Model Number T2756

Device Problems Material Deformation (2976); Unintended Movement (3026)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/18/2023

Event Type  malfunction  

Manufacturer Narrative

The customer has indicated the complaint sample will be returned to viant for evaluation but has not yet been received to date.Once the complaint sample is received, it will be investigated and a follow-up medwatch 3500a emdr will be submitted.G2: complaint information provided by distributor, zimmer biomet.Foreign as event occurred in canada.

Event Description

It was reported during an unknown patient procedure that the modular reamer shaft seems to have a sort of curve in it, doesn't reamer straight and isn't safe to use.No medical intervention necessary and no delay as another device was not needed to complete the procedure.No consequences or impact to patient.

Manufacturer Narrative

H2: the complaint sample was not returned to viant for evaluation.Thus, the reported event is non-verifiable.The current ifu sent with this device today, man-004006 rev.A, states the following; · end of life is determined by wear and damage due to intended use, · visually inspect for damage and wear.If the instrument is damaged and worn it is considered at the end of its life and should be discarded, · where instruments form part of a larger assembly, check assembly with mating components, · viant devices should only be used by qualified personnel fully trained in the use of the surgical instruments and the relevant surgical procedures, · do not modify viant instruments in any way and handle with care at all times.Surface scratches can increase wear and the risk of corrosion, · manual surgical instruments have a limited life-span which is determined by wear or damage due to repeated intended use.When a surgical instrument reaches the end of its functional life, clean the instrument of any and all biomaterial/biohazards and safely discard the instrument in accordance with applicable laws and regulations.The device history records (dhr) were reviewed and found no related manufacturing deviations or anomalies that would have contributed to the reported event.The device had experienced approximately 0.42 years of use.It is unknown as to how many surgical procedures (cycles) this device had experienced throughout its life in the field.The viant risk management files were still reviewed to ensure the reported failure mode (or similar) is captured and associated with surgical delay.The review revealed there are similar failure modes identified.In conclusion, the complaint sample was not received by viant for evaluation and so the reported event is non-verifiable.If the complaint sample is received by viant, it will be evaluated and the complaint record will be updated accordingly.Viant will continue to monitor for trends.H6: updated type of investigation, investigation findings, and investigation conclusions based on evaluation.

• Brand Name: EZ CLEAN REAMER HANDLE
• Type of Device: STRAIGHT REAMER HANDLE
• Manufacturer (Section D): VIANT MEDICAL, LLC; 4545 kroemer road; fort wayne IN 46818
• Manufacturer (Section G): VIANT MEDICAL, LLC; 4545 kroemer road; fort wayne IN 46818
• Manufacturer Contact: tony singh ; 4545 kroemer road; fort wayne, IN 46818
• MDR Report Key: 18192227
• MDR Text Key: 328807260
• Report Number: 3004976965-2023-00023
• Device Sequence Number: 1
• Product Code: LXH
• UDI-Device Identifier: 00840096401394
• UDI-Public: 00840096401394
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Distributor
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 12/21/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/22/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: T2756
• Device Catalogue Number: 00-1206-090-10
• Device Lot Number: 5548637
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/21/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/19/2023
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1