MAUDE Adverse Event Report: VIANT MEDICAL, LLC METAL HANDLE OFFSET CUP IMPACTOR

Model Number 255000115

Device Problem Failure to Disconnect (2541)

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

Event Date 03/16/2022

Event Type  malfunction  

Event Description

It was reported during an unknown patient procedure that handle cannot unthread from cup once impacted.No adverse events nor patient consequences were reported as a result of the malfunction.

Manufacturer Narrative

The complaint sample has not been received for evaluation.Once the complaint sample is received, it will be investigated and a follow-up medwatch 3500a emdr will be submitted.Date rec'd: complaint information provided by distributor, (b)(4).

Manufacturer Narrative

The complaint sample was not returned to viant for evaluation.Thus, the reported event is non-verifiable.The instructions for use (ifu) sent with this device, states the following; · end of life is generally determined by wear and damage due to intended use.· visually inspect for damage and wear.· check hinged instruments for smooth movement.· discard damaged instruments.· 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 lifespan which is generally 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) was reviewed and found no related manufacturing deviations or anomalies that would have contributed to the reported event.This device had experienced approximately 2.32 years of use.It is unknown as to how many surgical procedures (cycles) this device had experienced throughout its life in the field.If the complaint sample is received by viant, it will be evaluated and the complaint record will be updated accordingly and a supplemental medwatch 3500a emdr will be submitted as well.No further investigation is required at this time.H3: updated to state device not returned to manufacturer.H6: updated investigation findings and conclusions.

• Brand Name: METAL HANDLE OFFSET CUP IMPACTOR
• Type of Device: IMPACTOR
• 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: 14143011
• MDR Text Key: 289534166
• Report Number: 3004976965-2022-00004
• Device Sequence Number: 1
• Product Code: HWA
• 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,Followup
• Report Date: 05/16/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/19/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 255000115
• Device Catalogue Number: 511172
• Device Lot Number: PC4660931
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/16/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/21/2019
• 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