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

Model Number	255000140
Medical Device Problem Codes	Unstable (1667); Material Deformation (2976); Material Twisted/Bent (2981); Unintended Movement (3026)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/28/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H3: the customer has indicated the complaint sample will be returned to viant for evaluation but has not yet been received to date.Once the complaint sample is received, it will be investigated and a follow-up medwatch 3500a emdr will be submitted.G2: complaint information provided by distributor, depuy synthes.
Event or Problem Description
It was reported during an unknown procedure on a 70 year old female patient that the reamer shaft is slightly bent, leading to wobble while reaming.No pieces broke off and it is unknown if there was surgical delay.No consequences or impact to patient.
Additional Manufacturer Narrative
The complaint sample was returned to viant for evaluation and the reported event is confirmed.The straight reamer handle power adaptor is bent leading to the reported wobble / eccentric motion.The hudson power adaptor end was observed to be bent out of place and damaged with signs of material displacement and indentations from prolonged repeated use.Bending of this nature would not occur during normal intended use and likely would had occurred from applying non-linear load (off-axis force applied).Thus, the complaint sample had been misused.It is unknown what adaptor or power source (neither provided by viant) was connected to the device.Additionally the device has been used beyond the anticipated useful life of the device.The device was placed under power to simulate use and wobbling (eccentric motion) was observed due to the observed failures on the hudson power adaptor end.Other observations; the teflon sleeve was assembled backwards.The reamer head is able to retract and spring back in position as intended.The reamer head also had scratches and gouges from usage over time.The device can be easily disassembled and assembled as intended.The current ifu sent with this device today, man-004006 rev.A, 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, 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 has experienced approximately 1.33 years of use.It is unknown how many surgical procedures (cycles) this device has experienced throughout its life in the field.The viant risk management files were reviewed and the failure modes were identified and mitigated to the lowest possible level.A trend analysis was performed and similar complaints were attributed to misuse (off-axis force).The trend analysis reveals the estimated failure rate falls within the occurrence range identified in the viant risk management files.In conclusion, the reported event is confirmed as the returned straight reamer handle power adaptor is bent leading to the reported wobble / eccentric motion.From the investigation performed, the root cause attributed to the reported event is misuse (unintended use) as bending of this nature would not occur during normal intended use and likely would had occurred from applying non-linear load (off-axis force applied).Additionally, the device has experienced end of life from use beyond the anticipated useful life of the device.No further investigation with regard to this complaint is required.Viant will continue to monitor for trends.D9, g3, h3: device returned to viant for evaluation.H4: corrected device manufacture date.

• Brand Name: STRAIGHT REAMER HANDLE
• Common Device Name: STRAIGHT 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: 19004640
• Report Number: 3004976965-2024-00005
• Device Sequence Number: 15561943
• Product Code: LXH
• UDI-Device Identifier: 00840096400076
• UDI-Public: 00840096400076
• 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,Followup
• Report Date (Section B): 04/16/2024

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: 255000140
• Device Catalogue Number: T17652
• Device Lot Number: PC2595788
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/01/2024
• Supplement Date Received by Manufacturer: 04/15/2024
• Initial Report FDA Received Date: 03/29/2024
• Supplement Report FDA Received Date: 04/16/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/11/2013
• 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 Age: 70 YR
• Patient Sex: Female
• Patient Weight: 176 KG