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

Model Number 510912

Device Problems Break (1069); Failure to Disconnect (2541)

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

Event Date 06/08/2023

Event Type  malfunction  

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, stryker.

Event Description

It was reported during a primary left hip procedure that the offset cup impactor broke while impacting the cup implant.This break happened at the bend of assembly/disassembly mechanism.The failure led to difficulties disengaging the device from the cup implant.The surgeon was able to disengage the device with the use of a vice grip.The cup implant was not wasted, nor removed from the patient as it was positioned.The procedure was completed successfully with a surgical delay between 5 to 10 minutes due to the reported malfunction.There were no health consequences or impact.

Manufacturer Narrative

H2: the complaint sample was returned to viant for evaluation and the reported event is confirmed.The offset cup impactor was observed to have a fractured long shaft of the drive chain.The long shaft fractured in the middle of the pin hole location which keeps the rotating clip in place which clips on to the impactor body via the pull release latch.The device is worn as its apparent based on the damage found (scratches/nicks/gouges) from repeated use.However, the device is significantly worn as the impaction plate on the handle has experienced significant heavy impacts that has left deep impact marks and caused the ends of the plate to deform and mushroom.The significant impacts this device has experienced, coupled with the fracture of the long shaft, leads to the plausibility that the drive chain and locking mechanism were over-tightened when assembled with the implant cup (not provided by viant).This would cause the long shaft to bend from the applied forces and consequently lead to the fracture at the highest stress point.Note: stress = force / area, the fractured occurred in the middle of the pin hole of the long shaft.Further inspection of the device revealed the following other observations; the ratchet mechanism weld is cracked but not fractured all the way around.The threaded tip shows no signs of deformation or damage.The impactor body nose has signs of damage.The ratchet teeth show signs of wear from repeated use.The blue knob is damaged from the vice grip used to unscrew the fractured drive chain as indicated in the reported event.The pin on the blue knob has translated from its original position and is slightly protruding on the side of the knob.The universal joints (uj) on the chain shows no signs of breakage or deformation.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 device history records (dhr) was reviewed and found no related manufacturing deviations or anomalies that would have contributed to the reported event.The long shaft material and hardness met specifications.This device had experienced approximately 4.45 years of use.It is unknown as to how many surgical procedures (cycles) this device had experienced throughout its life in the field.The viant risk management files were reviewed and observed failure mode is captured and assessed within the viant device history files (dhf) and has been mitigated to the lower possible risk region.The trend analysis reveals the estimated failure rate falls below the occurrence range identified in the viant risk management files.In conclusion, the reported event is confirmed as the offset cup impactor was observed to have a fractured long shaft of the drive chain.From the investigation performed, the root cause is attributed to significant wear (stress & fatigue) from repeated and likely misused from over-tightening the locking mechanism.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: corrected component code & updated type of investigation, investigation findings, and investigation conclusions based on evaluation.

• Brand Name: METAL HANDLE OFFSET CUP IMPACTOR
• Type of Device: IMPACTOR
• Manufacturer (Section D): VIANT MEDICAL, LLC; 4545 kroemer road; fort wayne 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: 17259902
• MDR Text Key: 318771900
• Report Number: 3004976965-2023-00013
• 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: 510912
• Device Catalogue Number: 510912
• Device Lot Number: 4575072
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Manufacturer Received: 07/11/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/28/2018
• 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: 79 YR
• Patient Sex: Male