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 No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/08/2022

Event Type  malfunction  

Event Description

It was reported during a hip procedure on an unknown patient that the reamer handle attachment to the hudson reamer adaptor is worn on the flat cut outs that lock into the hudson adaptor.The reamer handle is spinning inside the hudson attachment and not locking in, causing over reaming of the implant cup and eccentric reaming.The offset reamer handle was then attached to a chuck attachment and the reamer attachment disconnected during reaming, causing the chuck attachment to break.There was a 15 minute delay to try the different attachment which broke and fragments were removed from the patient easily without intervention.The procedure was completed successfully with no adverse events nor patient consequences as a result of the 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.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).

Manufacturer Narrative

The complaint sample was not returned to viant for evaluation.Thus, the reported event is non-verifiable.After five (5) total documented attempts to retrieve the lot number for device 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 requested refurbishment which the viant medical instructions for use (ifu) prohibits modification/refurbishment of viant medical instruments.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.

• 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: 14090060
• MDR Text Key: 289334260
• Report Number: 3004976965-2022-00002
• 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: 05/16/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• 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: 03/14/2022
• Initial Date FDA Received: 04/12/2022
• Supplement Dates Manufacturer Received: 05/16/2022
• Supplement Dates FDA Received: 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