MAUDE Adverse Event Report: VIANT MEDICAL, LLC OFFSET REAMER HANDLE

Model Number	T17653
Medical Device Problem Codes	Fracture (1260); Vibration (1674); Unintended Movement (3026)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/06/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H3: the complaint sample was returned to viant for evaluation and the reported event is confirmed.The returned offset reamer handle had fractured at the power adaptor on the drive chain.From visual inspection, it is evident the power adaptor was fractured.The fracture face is not flat but angled which suggests an off-axis load (force) was applied to the power adaptor.It is likely (but unknown) that the offset reamer handle was attached to the power drill (not provided by viant medical) and the user may have held the offset reamer handle by the power drill handle instead of the handle on the device or had adjusted and angled the entire system of devices by maneuvering the handle of the drill.This off-axis load is then all transferred to the power adaptor shaft, which then coupled with wear/fatigue, could lead to the off-axis fracture face observed.The device shows evidence of heavy usage as the proximal universal joint (uj) is worn and nearing the end of its useful life.There are also signs of wear on the proximal uj forks as well.The hudson power adapter end also exhibits signs of wear along with heavy scratches/nicks on the fractured piece.Additionally, the blue grip has moved from its original location.The current ifu sent with this device today 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, where instruments form part of a larger assembly, check assembly with mating components, check hinged instruments for smooth movement, each component of the viant offset reamer handle is not a medical device, all components when assembled create the medical device.Therefore, the components of each viant reamer handle form a unique set when assembled.In no instance should the components from one offset reamer handle be mixed with components from another reamer handle.The unique device identification for this medical device is located on the assembled offset reamer handle, · 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.The device had experienced approximately 1.91 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 identified similar failure modes to the observed failure.From the trend analysis performed, the estimated failure rate falls within the occurrence rate identified in the viant risk management files.In conclusion, the reported event is confirmed as the returned offset reamer handle is fractured at the power adaptor on the drive chain.From the investigation performed, the root cause is attributed to an off-axis overload of force (shearing forces) applied to the drive chain leading to the power adaptor fracture.No further investigation with regard to this complaint is required.Viant will continue to monitor for trends.G2: complaint information provided by distributor, depuy synthes.Foreign as event occurred in germany.
Event or Problem Description
It was reported during an unknown patient procedure that the instrument wobbled and then fractured into two pieces.No consequences or impact to patient.

• Brand Name: OFFSET REAMER HANDLE
• Common Device Name: OFFSET REAMER HANDLE
• 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: 19492002
• Report Number: 3004976965-2024-00010
• Device Sequence Number: 20592289
• Product Code: LXH
• UDI-Device Identifier: 00840096400083
• UDI-Public: 00840096400083
• 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): 05/08/2024

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: T17653
• Device Catalogue Number: 255000100
• Device Lot Number: PC5392377-09
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/05/2024
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/08/2024
• Initial Report FDA Received Date: 06/07/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/08/2022
• 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