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

Model Number 255000115

Device Problems Fracture (1260); Off-Label Use (1494); Naturally Worn (2988)

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

Event Date 12/30/2019

Event Type  malfunction  

Manufacturer Narrative

The complaint sample was returned to viant for evaluation.Examination of the returned complaint sample confirms the reported event.The ratcheting teeth are worn and the ratchet weld has broken.Other observations: the 2 large pins that lock the chain into and under the oci body are deformed.The strike plate has been heavily impacted on all sides with obvious material deformation.The device finish is scratched, dinged and tarnished throughout the body.The latch plate mechanics are difficult to pull up and down.It can be seen there are numerous gouging and impaction marks on the blue knob as well as the sides of the handle.Neither the knob nor sides of the handle are intended for impaction.It should be noted the device instructions for use maintenance , inspection and testing states that the device should be visually inspected before use for damage and wear.If worn or damaged, the instrument is to be discarded.Reusable instruments have a limited lifespan.End of life is determined by wear and damage due to use.The device history records (dhr) were reviewed and no discrepancies were identified.This device had experienced approximately 4 years of use.It is unknown as to how many surgical procedures (cycles) this complaint sample had gone through throughout its life in the field.The viant risk management files were reviewed and the failure mode was identified and mitigated to the lowest possible level.In conclusion, the reported event is confirmed as the ratcheting teeth are worn and the ratchet weld has broken.Due to the damage to the instrument caused by unintended use, the age of the instrument, and the apparent wear damage, the root cause is attributed to wear and misuse.No further investigation with regard to this complaint is required.Viant will continue to monitor for trends.Complaint information provided by distributor, (b)(4).

Event Description

It was reported during an unknown patient procedure that the inserter disengages the locking mechanism during impaction of the cup and needs to be replaced.No adverse events nor patient consequence were reported as a result of the malfunction.

• Brand Name: METAL HANDLE OFFSET CUP IMPACTOR
• Type of Device: OFFSET CUP 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: 10518413
• MDR Text Key: 218671308
• Report Number: 3004976965-2020-00007
• 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
• Report Date: 01/06/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/10/2020
• 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: 3263966
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/31/2020
• Date Manufacturer Received: 05/11/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/30/2015
• 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