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 12/07/2022

Event Type  malfunction  

Event Description

It was reported during an unknown patient procedure that the cup cross threaded onto the impactor was stuck and could not be used in the case.This meant the instrument was broken and the implant was opened and unable to be used.Another impactor and cup were used to successfully complete the procedure.There was an unknown delay, but there were no adverse events or patient consequences as a result of the malfunction.

Manufacturer Narrative

The customer has indicated the complaint sample can be returned to viant for evaluation but has not been received.Once the complaint sample is received, it will be investigated and a follow-up medwatch 3500a emdr will be submitted accordingly.Complaint information provided by distributor, depuy synthes.Foreign as event occurred in australia.

Manufacturer Narrative

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 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 without any issues or complications.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 off damage and marks indicating the device may/had been used with the impactor tip which was not returned.· the ratchet teeth are worn from repeated use.· the metal handle has dents from possible impaction which is not intended on the handle.· the strike plate has been heavily impacted as there are deep impact marks.· the blue pom knob and adjoining shaft has been damaged from what appears to be a vise/clamp like tool based on the damaged observed.This is considered misuse as the knob is intended for hand rotation without use of other tools/instruments.· the chain is able to rotate within the impactor body with minimal friction which does not impede the device functioning as intended.· 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.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), & 800 (final inspection) during the assembly level and again at operation 800 (final inspection) during the final completed level.This device had experienced approximately 8.01 years of use.It is unknown as to how many surgical procedures (cycles) this device had experienced throughout its life in the field.From the investigation performed, the device has signs of non-normal use conditions as the device has been used beyond its expected useful life and possible misuse from damage indicative of a vise/clamp like tool.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 used beyond its expected useful life (8 years of use) and possible misuse from damage indicative of a vise/clamp like tool.No further investigation with regard to this complaint is required.D9/g3: new information received via device received by manufacturer.H6: updated type of investigation, investigation findings, and conclusions.

Manufacturer Narrative

The complaint sample was not returned to viant for evaluation.The customer instead provided an image of the offset cup impactor attached to the implant cup with blood throughout the devices.However, the reported event is non-verifiable as the picture provided is insufficient to determine the cause of the reported event.The instructions for use (ifu) sent with this device today, man-004011, 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.· 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 device history records (dhr) were reviewed and found no related manufacturing deviations or anomalies that would have contributed to the reported event.This device had experienced approximately 8.01 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.B5: event description updated based on new information.D9/g3: new information received from distributor (customer).H3: updated to state device not returned to manufacturer.H6: added health effect impact code and updated type of investigation, investigation findings, and conclusions.

Event Description

It was reported during a primary hip procedure on an unknown patient that the cup cross threaded onto the impactor was stuck and could not be used in the case.This meant the instrument was broken and the implant was opened and unable to be used.Another impactor and cup were used to successfully complete the procedure.There was a delay of 40 minutes, but there were no adverse events or patient consequences as a result of the malfunction.

• 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: 16138483
• MDR Text Key: 308267017
• Report Number: 3004976965-2022-00016
• 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: Foreign,Distributor
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 02/23/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/11/2023
• 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: PC2883763
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Manufacturer Received: 02/06/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/04/2014
• 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