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

Model Number 00-1206-090-10

Device Problems Unstable (1667); Unintended Movement (3026)

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

Event Date 02/01/2023

Event Type  malfunction  

Event Description

It was reported during an unknown patient procedure that the reamer wobbles when reaming the acetabulum.Another drill handle was tried and the handle still wobbled.Another reaming set was used to complete the procedure.No adverse events nor patient consequence were reported as a result of the malfunction.

Manufacturer Narrative

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.Lot: untraceable lot number provided by distributor.Awaiting corrected lot information.Report source: complaint information provided by distributor, zimmer biomet.Foreign as event occurred in canada.

Manufacturer Narrative

The complaint sample was returned incomplete to viant for evaluation and the reported event is confirmed.The straight reamer handle was returned disassembled without the teflon sleeve and exhibited a bent power adaptor leading to the reported issues.The stryker-zimmer hall power adaptor end was observed to be bent out of place and deformed with signs of material displacement and indentations.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.The device is intended to be used with the teflon sleeve to provide added grip and support for the surgeon (user) for better stability during reaming.It is possible if used without the teflon sleeve, coupled with the deformed power adaptor, the user could had experience the non-linear reaming.Other observations; the reamer head is able to retract and spring back in position as intended.The device can be easily disassembled and assembled as intended with exception of the teflon sleeve that was not returned.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 2.72 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.The root cause is attributed to non-normal use conditions as the device has been misused from applying a non-linear load (off-axis force applied).In conclusion, the reported event is confirmed as the returned straight reamer handle power adaptor is bent.From the investigation performed, the root cause is attributed to 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).No further investigation with regard to this complaint is required.Viant will continue to monitor for trends.

• Brand Name: STRAIGHT REAMER HANDLE
• Type of Device: 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: 16482243
• MDR Text Key: 310721481
• Report Number: 3004976935-2023-00003
• Device Sequence Number: 1
• Product Code: LXH
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Distributor
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 03/31/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/03/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 00-1206-090-10
• Device Catalogue Number: T2756
• Device Lot Number: 4942186
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Manufacturer Received: 03/31/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/15/2020
• 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