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

Model Number 255000100

Device Problems Misconnection (1399); Failure to Disconnect (2541)

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

Event Date 08/20/2022

Event Type  malfunction  

Manufacturer Narrative

The customer has indicated the complaint sample will be returned to viant for evaluation but has yet been received.Once the complaint sample is received, it will be investigated and a follow-up medwatch 3500a emdr will be submitted accordingly.Medical device reporting for manufacturers - guidance for industry and food and drug administration staff, issued on november 8, 2016, provides guidance on mdr reporting as it pertains to delay in surgery in section 4.1.It states: "if the failure of a device causes a delay in surgery and this delay may have caused or contributed to a death or serious injury to a patient, then this event would be reportable." for this particular reported event, no impact or consequence to the patient was reported.The guidance goes on to state, "if you determine that your device did not cause or contribute to a death or serious injury, the event may still be reportable if you determine that the device malfunctioned and the device, or similar device you market, would be likely to cause or contribute to a death or serious injury if the malfunction were to recur." due to the extended exposure of anesthesia of thirty (30) minutes and/or greater and potential complications which can occur during a hip replacement procedure, this event is being reported solely due to the thirty (30) minute and/or greater delay and not the malfunction.Complaint information provided by distributor, depuy synthes.Foreign as event occurred in (b)(6).

Event Description

It was reported during a total hip arthroplasty on the right hip joint of an unknown patient that there was a poor connection of the offset reamer handle.Several reamers were tried, but they were difficult to attach leading to one being unable to be removed and another handle being used for the procedure.The procedure was completed successfully with a 30 minute delay.No adverse events nor patient consequences were reported as a result of the malfunction.

Manufacturer Narrative

The complaint sample was returned to viant for evaluation and the reported event is confirmed.The returned offset reamer handle is unable to retract the reamer head mobile component completely causing the prongs to extrude out and inhibiting the crossbars of an acetabular reamer to attach and disconnect as intended.The device was returned to viant disassembled.After visual inspection it was evident the reported event was caused by the deformed z-tube end.The deformation of the z-tube ends have been previously investigated and determined to be caused by improper disassembly where the distal lip gets caught on the distal ball bearings and/or the reamer attachment coupling flange.The instructions for use (ifu) sent with this device, d3.3.1.31nt rev.A, depicts the proper assembly and disassembly steps for the offset reamer handle.In addition, it is evident that the device has been misused as the returned assembly is mixed from components from another reamer handle.This device is not intended to be mixed with components from another device and thus is considered misuse.The returned assembly was comprised of the below mixed components; index handle & drive chain: lot "4239538-18", aged 3.99 years z-tubes (both): lot "4239538-11", aged 3.99 years the components of each viant offset reamer handle form a unique set when assembled.In no instance should the components from one reamer handle be mixed with components from another device as instructed by the current ifus man-004006 & man-004012.The current ifu sent with this device today, man-004006 rev.A, states the following; end of life is generally 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) was reviewed and found no related manufacturing deviations or anomalies that would have contributed to the reported event.The device had experienced approximately 3.99 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 malfunction.However, this device was not used under normal use conditions as the device has been misused from improper disassembly and was mixed with components from another reamer handle.In conclusion, the reported event is confirmed as the returned offset reamer handle is unable to retract completely causing the prongs to extrude out and inhibiting the crossbars of an acetabular reamer to attach as intended.From the investigation performed, the root cause is attributed to misuse due to improper disassembly and mixed components.No further investigation with regard to this complaint is required.D9: updated device available for evaluation.H2: corrected medical device component code.H3: updated device evaluated by manufacturer.H6: updated type of investigation, investigation findings, and investigation conclusions.H10: viant attempted to submit follow-up 001 medwatch 3500a emdr for manufacturer report number 3004976965-2022-00008 via fda esg on 20-oct-2022 (within 30 days of initial medwatch 3500a emdr submitted on 21-sep-2022).However, the follow-up submission had failed.The device was then returned for evaluation on 09-nov-2022 and the evaluation was then performed on 10-nov-2022 and follow-up 001 was updated accordingly.Since 20-oct-2022, viant medical has been in communication with fda esg helpdesk (ticket (b)(4)) to resolve the issue with numerous documented emails to no avail until this successful submission of follow-up 001 of 3004976965-2022-00008.

• Brand Name: OFFSET 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: 15595505
• MDR Text Key: 307078979
• Report Number: 3004976965-2022-00008
• 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: 11/10/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/13/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 255000100
• Device Catalogue Number: T17653
• Device Lot Number: PC4239538
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Manufacturer Received: 11/10/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/24/2018
• 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
• Patient Outcome(s): Other