MAUDE Adverse Event Report: VIANT MEDICAL, LLC ACETABULAR REAMER 52 MM

Model Number MFR31005210CR01

Device Problems Product Quality Problem (1506); Dull, Blunt (2407)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/15/2019

Event Type  malfunction  

Manufacturer Narrative

The complaint sample has not been received for evaluation.Once the complaint sample is received, it will be investigated and a follow-up medwatch 3500a emdr will be submitted.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 forty-five (45) minutes and potential complications which can occur during a hip replacement procedure, this event is being reported solely due to the forty-five (45) minute delay and not the malfunction.Foreign report source: complaint information provided by distributor, amplitude.Foreign as the event occurred in (b)(6).

Event Description

It was reported during surgery that the reamer does not ream anymore.A forty-five (45) minute increase to surgical time was reported.No adverse event nor patient injury was reported as a result of the malfunction.

Manufacturer Narrative

The complaint sample was returned to viant for evaluation and the reported event was confirmed.Some of the cutting teeth on the reamer were dull and had nicks and gouges out of them.There were scratches and nicks throughout the surface of the reamer as well.This reamer was in a group of three (3) reamers reported by the distributor.These three (3) reamers had been in the field for approximately 6.17 years.It is unknown as to how many surgical procedures (cycles) this reamer had gone through throughout its life in the field.Based on the wear observed and the amount of time in the field, this reamer had exceeded its expected useful life.The viant (legacy greatbatch) risk management files were reviewed and the failure mode was identified and mitigated to the lowest possible level.Per the trend analysis, the failure rate falls below the occurrence rate identified in the viant (legacy greatbatch) risk management files.In conclusion, the reported event is confirmed and is attributed to wear.This reamer has exceeded its expected useful life as it has signs of normal wear and tear from repeated intended use.No further investigation is required.Updated based upon returned device.Device, method, result and conclusion codes updated based upon investigation results.

• Brand Name: ACETABULAR REAMER 52 MM
• Type of Device: ACETABULAR REAMER
• Manufacturer (Section D): VIANT MEDICAL, LLC; 4545 kroemer road; fort wayne IN 46818
• MDR Report Key: 8982282
• MDR Text Key: 218547355
• Report Number: 3004976965-2019-00031
• Device Sequence Number: 1
• Product Code: HTO
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign
• Type of Report: Initial,Followup
• Report Date: 11/01/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/10/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: MFR31005210CR01
• Device Catalogue Number: T2469
• Device Lot Number: GB2430289
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/17/2019
• Date Manufacturer Received: 11/01/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other