MAUDE Adverse Event Report: DT MEDTECH, LLC HINTERMANN SERIES H2 POLY ASSEMBLY; ANKLE, POLY COMPONENT

Model Number 321305

Device Problem Improper or Incorrect Procedure or Method (2017)

Patient Problem No Information (3190)

Event Date 11/05/2019

Event Type  Injury  

Event Description

Revision surgery on asymptomatic patient at 6 weeks post-op based on xray results indicating movement/malalignment of ankle joint.

• Brand Name: HINTERMANN SERIES H2 POLY ASSEMBLY
• Type of Device: ANKLE, POLY COMPONENT
• Manufacturer (Section D): DT MEDTECH, LLC; 110 west road; suite 227; towson MD 21204
• Manufacturer Contact: 110 west road; suite 227; towson, MD 21204
• MDR Report Key: 9419291
• MDR Text Key: 185502013
• Report Number: 3012104767-2019-00003
• Device Sequence Number: 1
• Product Code: HSN
• UDI-Device Identifier: 00+B0953213051
• UDI-Public: +B0953213051
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K171004
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date: 12/06/2019

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 Expiration Date: 12/28/2022
• Device Model Number: 321305
• Device Catalogue Number: 321305
• Device Lot Number: AAAER
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/05/2019
• Initial Date Manufacturer Received: 11/05/2019
• Initial Date FDA Received: 12/05/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/28/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other