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

Model Number	511172
Medical Device Problem Codes	Mechanical Problem (1384); Mechanical Jam (2983)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/05/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported during an unknown procedure on a male patient that the knob on cup inserter is stiff which making the release of the cup difficult after impacting.There was no surgical delay and no consequences or impact to patient.
Additional Manufacturer Narrative
H3: the complaint sample was returned to viant for evaluation and the reported event is confirmed.The offset cup impactor has a bent universal joint (uj) causing the drive chain to slightly seize/jam.From visual and function inspection, it was evident the device has a bent uj.The bent uj causes an interference when assembled within the impactor body, leading to the seizure which does not allow the drive chain to rotate smoothly as intended.Additionally, several other notable failures were found.The ratchet mechanism weld has cracks on both ends.The ratchet teeth are also worn from repeated use.Prolonged use and wear would likely lead to failures from over-tightening the device.The impaction plate on the handle has experienced significant impacts from repeated use.The device has general wear and tear in the form of scratches/nicks/gouges from repeated use.Based on the age and condition of the returned device, the device has reached the end of its useful life.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.This device has experienced approximately 6.37 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 the failure mode was identified and mitigated to the lowest possible level.The estimated failure rate falls within the occurrence rate identified in the viant risk management files for this failure mode.In conclusion, the reported event is confirmed as the returned offset cup impactor has a bent universal joint (uj) causing the drive chain to slightly seize/jam.From the investigation performed, the root cause is attributed to product end of life (wear).No further investigation with regard to this complaint is required.Viant will continue to monitor for trends.D4: primary udi# provided is the current viant medical udi-di for model number: 511172.The additional udi# provided is the legacy greatbatch medical udi-di for model number: 511172 prior to viant medical acquisition of the product.This lot number was manufactured in 2018 by greatbatch medical.Viant medical acquired this product line from greatbatch medical (subsidiary of integer holdings) in 2018.Therefore, the legacy udi-di# is provided as the additional udi# and the current udi-di# is provided as the primary udi#.G2: complaint information provided by distributor, depuy synthes.

• Brand Name: VIANT MEDICAL, LLC
• Common Device Name: METAL HANDLE 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: 21584661
• Report Number: 3004976965-2025-00002
• Device Sequence Number: 15661682
• Product Code: HWA
• UDI-Device Identifier: 00840096400045
• UDI-Public: 00840096400045
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 02/11/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 511172
• Device Catalogue Number: 511172
• Device Lot Number: PC4194849
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/04/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/11/2025
• Initial Report FDA Received Date: 03/12/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/24/2018
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Male