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

Model Number	255000115
Medical Device Problem Codes	Mechanical Problem (1384); Mechanical Jam (2983); Damaged Thread (4075)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/26/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported during a hip surgery on an unknown patient that the offset cup impactor threads are damaged.It will not release the cup after impaction / insertion and risks the cup moving from optimal positioning.The surgeon took their time to remove the cup from the impactor resulting in a five (5) minute delay in surgery.The procedure was completed successfully with no consequences or impact to patient.
Additional Manufacturer Narrative
The complaint sample was not returned to viant for evaluation.Thus, the reported event is non-verifiable.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 record (dhr) review was not performed as the lot number is unknown.It is unknown how many surgical procedures (cycles) this device has experienced throughout its life in the field as the lot number is unknown to determine the date of manufacture.The viant risk management files were reviewed to ensure the reported failure mode is captured and assessed.The review revealed there are similar failure modes identified and mitigated to the lowest possible risk region.In conclusion, the complaint sample was not received by viant for evaluation and the reported event is non-verifiable.If the complaint sample is received by viant, it will be evaluated and the complaint record will be updated accordingly.No further investigation with regard to this complaint is required at this time.Viant will continue to monitor for trends.G2: complaint information provided by distributor, depuy synthes.Foreign as the event occurred in canada.

• Brand Name: METAL HANDLE OFFSET CUP IMPACTOR
• Common Device Name: 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: 18999357
• Report Number: 3004976965-2024-00004
• Device Sequence Number: 11480138
• 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: Foreign,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 02/28/2024

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: 255000115
• Device Catalogue Number: 511172
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/28/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown