MAUDE Adverse Event Report: METAL HANDLE OFFSET CUP IMPACTOR

Model Number 255000115

Device Problems Failure to Disconnect (2541); Deformation Due to Compressive Stress (2889); Material Deformation (2976)

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

Event Date 09/16/2021

Event Type  malfunction  

Event Description

It was reported during a total hip replacement a direct anterior approach that the surgeon was unable to remove the offset acetabular impactor after seating of the acetabular cup as it would not unthread from the cup.The cup had to be removed along with the instrument and re-inserted using another similar device.There was a three minute delay, but no adverse events nor patient consequence 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.Complaint information provided by distributor, (b)(4).Foreign as the event occurred in (b)(6).

Manufacturer Narrative

The complaint sample was returned incomplete to viant for evaluation and the reported event is confirmed.The offset cup impactor has a deformed universal joint (uj) on the drive chain.The removable impactor tip (nose) was not returned with the device for evaluation.From initial inspection, it was evident that the uj was deformed as one of the forks of the uj is bent outward not allowing the drive chain mechanism to rotate within the impactor body as it makes contact with the inner wall.This will not allow the drive mechanism to rotate to allow the implant cup to be securely attached to the device for implantation, nor allow the implant to be unthreaded (disengaged) from the device as intended.Other observations; · the ratchet weld has slight cracks at the end of the weld.· the strike plate has many deep impact marks from repeated use.· the ratchet teeth are worn in the central area which is expected from intended use.· the blue knob has been damaged from what appears to be from pliers (vice) which is suspected to be used due to the drive chain mechanisms inability to turn by hand due to the deformation of the uj fork.· the device has general wear and tear in the form of scratches/nicks/gouges from repeated use.Per the above observations, the device has failed due to wear from repeated intended use.The ifu sent with this device today, man-000197 rev b, 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 life-span 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 viant risk management files were reviewed and the failure mode was identified and mitigated to the lowest possible level.A trend analysis was performed and the complaint rate fall within the identified occurrence rate in the viant risk management files.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 6.81 years of use.It is unknown as to how many surgical procedures (cycles) this device had experienced throughout its life in the field.However, uj deformed due to wear from repeated use causing the mechanism to become worn and fatigued over time from its 6.81 years of use.In conclusion, the reported event is confirmed as the offset cup impactor has a deformed universal joint (uj) on the drive chain.From the investigation performed, the root cause is attributed to wear heavy usage.D9: device available for evaluation updated.H6: updated medical device product code, component code, investigation findings, and conclusions based on the investigation performed.

• Brand Name: METAL HANDLE OFFSET CUP IMPACTOR
• Type of Device: IMPACTOR
• MDR Report Key: 12646905
• MDR Text Key: 281212745
• Report Number: 3004976965-2021-00006
• Device Sequence Number: 1
• Product Code: HWA
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign
• Type of Report: Initial,Followup
• Report Date: 11/03/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/18/2021
• 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: PC2883761
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/29/2021
• Date Manufacturer Received: 11/03/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/26/2014
• 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