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

Model Number 00-1206-090-10

Device Problems Unstable (1667); Material Deformation (2976); Material Twisted/Bent (2981); Unintended Movement (3026)

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

Event Date 03/20/2024

Event Type  malfunction  

Manufacturer Narrative

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 record (dhr) review was not performed as the lot number is unknown.It is unknown how many surgical procedures (cycles) this device has experienced throughout its life in the field as the lot number is unknown to determine the date of manufacture.The viant risk management files were reviewed to ensure the reported failure mode (or similar) is captured and assessed.The review revealed there are similar failure modes identified and mitigated to the lowest possible risk region.In conclusion, the complaint sample was not received by viant for evaluation and the reported event is non-verifiable.If the complaint sample is received by viant, it will be evaluated, the complaint record will be updated accordingly, and a supplemental medwatch 3500a emdr will be submitted as well.No further investigation with regard to this complaint is required at this time.Viant will continue to monitor for trends.Complaint information provided by distributor, zimmer biomet.

Event Description

It was reported during an unknown procedure of a 62 year old male patient that the reamer shaft wobbled and must have a slight bend in it.The case was completed with a second device.No consequences or impact to patient.

• 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: 19163011
• MDR Text Key: 341671229
• Report Number: 3004976965-2024-00008
• 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: Distributor
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 03/25/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/23/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 00-1206-090-10
• Device Catalogue Number: T2756
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/25/2024
• Was Device Evaluated by Manufacturer?: No
• 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
• Patient Age: 62 YR
• Patient Sex: Male