MAUDE Adverse Event Report: VIANT MEDICAL, LLC OFFSET REAMER HANDLE

Model Number T17653

Device Problems Unstable (1667); Unintended Movement (3026)

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

Event Date 09/20/2023

Event Type  malfunction  

Event Description

It was reported during a total hip replacement on an unknown patient that the offset grater handle had a wobble while reaming.After the case the instrument was disassembled and inspected and found the universal joint had significant wear and was ready to break.No consequences or impact to patient.

Manufacturer Narrative

H10: the complaint sample was not returned to viant for evaluation.Thus, the reported event is non-verifiable.The customer indicated the universal joint (uj) had significant wear and was ready to break which is indicative the device has likely been used up to or beyond its anticipated useful life.It's likely the root cause is attributed to wear / end of life, however it cannot be verified without the device being returned to viant for evaluation.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, · check hinged instruments for smooth movement, · each component of the viant offset reamer handle is not a medical device, all components when assembled create the medical device.Therefore, the components of each viant reamer handle form a unique set when assembled.In no instance should the components from one offset reamer handle be mixed with components from another reamer handle.The unique device identification for this medical device is located on the assembled offset reamer handle, · 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 found no related manufacturing deviations or anomalies that would have contributed to the reported event.The device had experienced approximately 3.50 years of use.It is unknown as to how many surgical procedures (cycles) this device had experienced throughout its life in the field.However based on the age and description of the drive chain, the device has likely been used up to or beyond its anticipated useful life.In conclusion, viant is unable to verify the alleged malfunction as the device was not returned for evaluation.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 accordingly.Viant will continue to monitor for trends.No further investigation is required at this time.G2: complaint information provided by distributor, depuy synthes.

• Brand Name: OFFSET REAMER HANDLE
• Type of Device: OFFSET 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: 17995619
• MDR Text Key: 326379912
• Report Number: 3004976965-2023-00021
• Device Sequence Number: 1
• Product Code: LXH
• UDI-Device Identifier: 00840096400083
• UDI-Public: 00840096400083
• 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: 09/25/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/24/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: T17653
• Device Catalogue Number: 255000100
• Device Lot Number: PC4965427
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/25/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/23/2020
• 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