MAUDE Adverse Event Report: VIANT MEDICAL, LLC METAL HANDLE OFFSET CUP IMPACTOR

Model Number 255000115

Device Problems Mechanical Problem (1384); Use of Device Problem (1670)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/22/2019

Event Type  malfunction  

Manufacturer Narrative

The complaint sample was not received by viant for evaluation and the reported event is non-verifiable.A photograph was received that showed a metal handle offset cup impactor with an implant allegedly still attached to it.However, the ratchet teeth/key was still assembled to the impactor body.The chain release trigger is to be pressed and the ratchet teeth/key removed before the implant is to be unthreaded from the impactor.This may be contributing to the alleged inability to remove the implant as it may still be securely ratcheted down.Instructions for use (ifu) that were shipped with this oci depict this disassembly process.The blue knob on the impactor also looks deformed from the photograph, which is not consistent with intended use.Analysis of production records did not reveal any discrepancies.In conclusion, the reported event is non-verifiable as the complaint sample was not received for evaluation.It has been indicated at this time the device is not returning but if the device is received, a follow-up medwatch 3500a will be submitted.Reported by distributor, (b)(4).Foreign as the event occurred in (b)(6).

Event Description

It was reported during an unknown patient procedure that the offset cup impactor is faulty and won't release the cup.The cup was implanted and the release handle just spins without releasing the cup.The procedure was completed with another device and there was a ten (10) minute surgical delay reported.No adverse events nor patient consequence were reported as a result of the malfunction.

• Brand Name: METAL HANDLE OFFSET CUP IMPACTOR
• Type of Device: IMPACTOR
• 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: 9497166
• MDR Text Key: 218671092
• Report Number: 3004976965-2019-00046
• Device Sequence Number: 1
• Product Code: HWA
• Combination Product (y/n): N
• 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: 11/27/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/19/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 255000115
• Device Catalogue Number: 511172
• Device Lot Number: PC2883771
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/27/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/20/2014
• 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