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

Model Number 510912

Device Problem Mechanical Problem (1384)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/12/2019

Event Type  malfunction  

Manufacturer Narrative

The complaint sample was not received by viant for evaluation and the reported event is non-verifiable.The receipt of the complaint sample is not anticipated, however if for some reason it is received by viant, it will be evaluated and a follow-up medwatch 3500a submitted as required.Report source is the distributor, stryker orthopaedics.Lot number unknown.

Event Description

It was reported during a right total hip procedure that on implanting cup with offset inserter the trident cup got stuck on inserter whereas the inner diameter would not come out of the cup.A new cup was used to finish the process and implant the cup with straight inserter and impactor.The surgery was completed successfully with no delay.No adverse consequence were reported as a result of the malfunction.

• Brand Name: METAL HANDLE OFFSET CUP IMPACTOR
• Type of Device: CUP 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: 9273916
• MDR Text Key: 217133278
• Report Number: 3004976965-2019-00029
• Device Sequence Number: 1
• Product Code: HWA
• 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: 09/04/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/04/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 510912
• Device Catalogue Number: 510912
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/04/2019
• 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 Age: 60 YR
• Patient Weight: 92