MAUDE Adverse Event Report: VIANT MEDICAL, LLC ACETABULAR REAMER 49MM

Model Number MFR31004910CR01

Device Problems Dull, Blunt (2407); Naturally Worn (2988)

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

Event Date 05/26/2020

Event Type  malfunction  

Manufacturer Narrative

The complaint sample was not returned to viant for evaluation and the reported event is non-verifiable.The customer indicated they will not return the device.However, surgical instruments are susceptible to wear and tear, and therefore should be checked for defects before use.The customer provided photography that suggests the device has been well used.The cutting edges appear to be dulled and nicked.The surface finish appears scratched and gouged in several places.The lot code indicates this device is 10 year(s), 5 month(s) into distribution and would suggest the device has far outlived its expected useful life.Without physical examination of the reported device, no further conclusions can be drawn.If the complaint sample is received by viant, it will be evaluated and the complaint record will be updated and a supplemental follow-up medwatch 3500a emdr will be submitted accordingly.In conclusion, the reported event is non-verifiable as the complaint sample was not returned for evaluation.However, the photographs provided by the customer suggest the device has far outlived its expected useful life.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 known 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 potential complications which can occur during a hip replacement procedure, this event is being reported solely due to the thirty (30) minute delay and not the malfunction.Complaint information provided by distributor, (b)(4).Foreign as the event occurred in (b)(6).

Event Description

It was reported during an unknown patient procedure that the surgeon could not cut well.Operation time was extended 30 minutes.No other adverse events nor patient consequence were reported as a result of the malfunction.Procedure was completed successfully.

• Brand Name: ACETABULAR REAMER 49MM
• Type of Device: REAMER
• 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: 10590461
• MDR Text Key: 218672363
• Report Number: 3004976965-2020-00009
• Device Sequence Number: 1
• Product Code: HTO
• Combination Product (y/n): N
• Reporter Country Code: JA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 08/24/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: MFR31004910CR01
• Device Catalogue Number: T14190
• Device Lot Number: 8360070001
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 08/27/2020
• Initial Date FDA Received: 09/25/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/17/2009
• 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