MAUDE Adverse Event Report: PARAGON 28, INC. HAMMERTUBE SYSTEM; HAMMERTUBE IMPLANT

Model Number P40-002-0275-S

Device Problems Break (1069); Positioning Problem (3009)

Patient Problem Insufficient Information (4580)

Event Date 05/18/2018

Event Type  malfunction  

Manufacturer Narrative

Identifying information, such as the lot number of the device was not reported to paragon 28.Case information including related patient information was not provided by the initial reporter.The device history record was reviewed and met all material specifications with no deviation identified.Devices are not expected to be returned for the manufacturer review/investigation.If any further information is found which would change or alter any conclusions or information, a supplemental report will be filed accordingly.

Event Description

It was reported that the patient underwent a surgical procedure that utilized paragon 28 hammertube system on (b)(6) 2018.The angled hammertube implant was reported broken intra-operatively.It was reported that the surgeon experienced difficulty putting the implant into the proximal phalanx and tamp the implant until the plasma spray was inside the canal.The initial reporter believed the device was far enough however, the implant broke with one additional tamp.

• Brand Name: HAMMERTUBE SYSTEM
• Type of Device: HAMMERTUBE IMPLANT
• Manufacturer (Section D): PARAGON 28, INC.; 14445 grasslands dr.; englewood CO 80112
• Manufacturer Contact: victoria akinboboye ; 14445 grasslands dr.; englewood, CO 80112 ; 7206431300
• MDR Report Key: 10933201
• MDR Text Key: 219548916
• Report Number: 3008650117-2020-00209
• Device Sequence Number: 1
• Product Code: HTY
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K171715
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 12/01/2020

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: P40-002-0275-S
• Device Catalogue Number: P40-002-0275-S
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/18/2018
• Initial Date FDA Received: 12/02/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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