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

Model Number 255000100

Device Problems Loose or Intermittent Connection (1371); Unintended Movement (3026)

Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 02/25/2022

Event Type  Injury  

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.Lot number is unknown at this time as it has not been provided.Consequently the manufacturing date is unknown at this time.Complaint information provided by distributor, depuy synthes.Foreign as the event occurred in (b)(6).(b)(4).

Event Description

It was reported during a direct anterior arthroplasty that the reamer attachment to power tools does not engage correctly, does not connect and ream in a linear fashion.There was a surgical delay of 20 minutes indicated due to the malfunction.The patient was elderly and had excessive bleeding (2.5 liters of blood lost) during reaming as 3 implant cups were attempted to be implanted leading to acquiring additional blood and x-rays.No further adverse events nor patient consequences were reported as a result of the malfunction.The 3rd implant cup was seated correctly and the procedures was completed successfully.

Manufacturer Narrative

The complaint sample was not returned to viant for evaluation.Thus, the reported event is non-verifiable.After nine (9) total documented attempts to retrieve the lot number and the device for traceability and evaluation, it is unknown if the subject device of the reported event is a viant medical device based on the lot number provided which was not a valid viant medical lot number.In addition, without the subject device available for viant medical to evaluate, the device traceability and root cause of the alleged malfunction are unknown.The customer has also indicated their customer is retaining the device for an unknown reason after viant medicals repeated requests to remove the device from the field and returned for evaluation.In conclusion, the reported event is non-verifiable.Based on the above, viant medical will not submit medical device reports (mdrs) for this malfunction for recurrences as the lot number received suggests the device may not likely be a viant medical device or was refurbished/modified out of the viant medical specifications.Refurbishment/modification is plausible, as the customer had indicated the device "need to be refurbished".If the complaint sample is received by viant, it will be evaluated and the complaint record will be updated accordingly.No further investigation with regard to this complaint is required.Viant will continue to monitor for trends.

Manufacturer Narrative

An incomplete complaint sample was returned to viant for evaluation.Thus, the reported event is non-verifiable.On (b)(6) 2022, the index handle of the offset reamer handle (comprised of an index handle, 2 z-tubes, and drive chain) was returned for evaluation.Based on the initial investigation performed, the component of interest (based on the reported event and speculation) for the investigation is the drive chain or the entire offset reamer handle assembly as a whole.Thus, the incomplete offset reamer handle and index handle does not assist with determining the root cause and the complaint is still considered non-verifiable.It is truly unknown if this component was used in the reported event as visual inspection and function check of the index handle (without the other components) shows it is in great condition with minimal signs of wear and tear from approximately 4 years of repeated use.There are minor cosmetic scratches and a dent found but it does not affect fit, form, or function.Without the entire offset reamer handle assembly available for viant medical to evaluate, the device traceability (of all components) and root cause of the alleged malfunction are still unknown and it is still plausible the offset reamer handle could had been interchanged with components from other reamer handles.In conclusion, the reported event is non-verifiable.Based on the above, viant medical will not submit medical device reports (mdrs) for this malfunction for recurrences as device traceability of all components are still unknown.The customer had also indicated their customer is retaining the device for an unknown reason after viant medicals repeated requests to remove the device from the field and returned for evaluation.It is evident the other 3 components which build the offset reamer handle assembly were withheld from being returned to viant for evaluation.The customer has also requested refurbishment which the viant medical instructions for use (ifu) prohibits modification/refurbishment of viant medical instruments.If the complaint sample is received by viant, it will be evaluated and the complaint record will be updated accordingly.No further investigation with regard to this complaint is required.Viant will continue to monitor for trends.

• 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: 13952826
• MDR Text Key: 289334158
• Report Number: 3004976965-2022-00001
• 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,Followup
• Report Date: 05/16/2022

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: 255000100
• Device Catalogue Number: T17653
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 03/01/2022
• Initial Date FDA Received: 03/30/2022
• Supplement Dates Manufacturer Received: 05/05/2022; 05/16/2022
• Supplement Dates FDA Received: 05/06/2022; 05/16/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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): Required Intervention