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

Model Number 255000115

Device Problems Failure to Disconnect (2541); Mechanical Jam (2983)

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

Event Date 06/05/2023

Event Type  malfunction  

Event Description

It was reported during a total hip replacement that the acetabular component difficult to remove after impaction.It is unknown if there were any health consequences or impact to patient.

Manufacturer Narrative

The complaint sample has not yet been returned to viant for evaluation.Once the complaint sample is received, it will be evaluated and a follow-up medwatch 3500a emdr will be submitted accordingly.G2: complaint information provided by distributor, depuy synthes.

Manufacturer Narrative

H2: the complaint sample was returned incomplete to viant for evaluation and the reported event is unconfirmed.The offset cup impactor was returned without the impactor tip but had functioned when threading on and off a cup fixture numerous times under tension without fail as intended.To evaluate the reported failure, the function of the device was checked using a cup fixture per the viant impactor function and resistance test work instruction.The device was able to thread on and off and cup fixture numerous times under tension without any issues or complications.A test impactor tip was utilized as the impactor tip was not returned and the offset cup impactor is intended to be used with it to perform its intended purpose.It is unknown whether or not the impactor tip was used during the surgical procedure.If the device was used without a removable nose (not the intended use), the ratchet mechanism would have to be tightened/ratcheted down to an extreme degree, which is not intended.This would likely lead to additional unintended failures (fractures and/or deformations).Per the above evaluation, the reported event is unconfirmed.Further inspection of the device revealed the following other observations; the threaded tip shows no signs of deformation or damage from threading on and off the cup fixture.The impactor body nose has signs of damage and marks indicating the device may/had been used with the impactor tip.The ratchet teeth show signs of wear from repeated use.The metal handle has dents from off-axis impactions.Impacts on the handle add off-axis forces on the device.The strike plate at the end of the metal handle is intended for impactions.This is considered misuse.The chain is able to rotate within the impactor body but there was slight jamming/friction observed likely from contacting the impactor body.This however does not inhibit the device from functioning which was verified when the function of the device was assessed for the reported event.The universal joints (uj) on the chain shows no signs of breakage or deformation.The device has general wear and tear in the form of scratches/nicks/gouges from repeated use.The ifu sent with this device today, man-004011 rev b, states the following; offset cup impactors are hand-held, re-usable surgical instruments[?].Anticipated useful life offset cup impactor: 600 use cycles, 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, check hinged instruments for smooth movement, when the udi carrier(s) is no longer readable, the instrument is to be discarded, 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 viant risk management files were reviewed to the reported failure mode is captured and assessed within the viant device history files (dhf).The review revealed there is a similar failure mode identified and mitigated to the lower possible risk region.It was noted during the trend review, the 4 recent similar reported events had all occurred in the same user facility (3 from the same user).All determined to be unconfirmed.The device history records (dhr) was reviewed and found no related manufacturing deviations or anomalies that would have contributed to the reported event.Assembly of the offset cup impactor with a cup fixture was verified at 100% frequency in operation 140 (assembly), 300 (assembly), & 1 per lot at op 800 (final inspection) during the assembly level.This device has experienced approximately 1.28 years of use.It is unknown exactly how many surgical procedures (cycles) this device has experienced throughout its life in the field.In conclusion, the reported event is unconfirmed since the returned offset cup impactor functioned when threading on and off the cup fixture numerous times without fail as intended.Additionally from the investigation performed, the device has signs of non-normal use conditions as the device has been misused from damage indicative of off-axis impactions on the metal handle instead of the strike plate.No further investigation with regard to this complaint is required.Viant will continue to monitor for trends.D9, g3: device returned to manufacturer for evaluation.H2, h6: updated type of investigation, investigation findings, and investigation 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: 17256419
• MDR Text Key: 318650954
• Report Number: 3004976965-2023-00011
• 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: 08/04/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/05/2023
• 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: PC5328145
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Manufacturer Received: 07/27/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/22/2022
• 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: 22 YR
• Patient Sex: Female