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

Model Number 255000140

Device Problems Unstable (1667); Material Deformation (2976); Material Twisted/Bent (2981); Unintended Movement (3026)

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

Event Date 02/28/2024

Event Type  malfunction  

Manufacturer Narrative

H3: the customer has indicated the complaint sample will be returned to viant for evaluation but has not yet been received to date.Once the complaint sample is received, it will be investigated and a follow-up medwatch 3500a emdr will be submitted.G2: complaint information provided by distributor, depuy synthes.

Event Description

It was reported during an unknown procedure on a 70 year old female patient that the reamer shaft is slightly bent, leading to wobble while reaming.No pieces broke off and it is unknown if there was surgical delay.No consequences or impact to patient.

• Brand Name: STRAIGHT REAMER HANDLE
• Type of Device: STRAIGHT 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: 19004640
• MDR Text Key: 339005274
• Report Number: 3004976965-2024-00005
• Device Sequence Number: 1
• Product Code: LXH
• UDI-Device Identifier: 00840096400076
• UDI-Public: 00840096400076
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Distributor
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 03/01/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/29/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 255000140
• Device Catalogue Number: T17652
• Device Lot Number: PC2595788
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/01/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 11/12/2013
• 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 Age: 70 YR
• Patient Sex: Female
• Patient Weight: 176 KG