MAUDE Adverse Event Report: PARAGON 28, INC. HAMMERTUBE SYSTEM; HAMMERTUBE IMPLANT, 2.75MM, 10 DEGREE CANNULATED

Model Number P40-002-0275-S

Device Problem Break (1069)

Patient Problem Foreign Body In Patient (2687)

Event Date 01/11/2018

Event Type  malfunction  

Manufacturer Narrative

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 on (b)(6) 2018 that utilized paragon 28 hammertube system.The initial reporter stated that the hammertube 2.75mm 10 degree cannulated implant broke on insertion and the broken pieces was left in the patient.A k-wire was implanted to stabilize the joint.A revision surgery was not reported.

• Brand Name: HAMMERTUBE SYSTEM
• Type of Device: HAMMERTUBE IMPLANT, 2.75MM, 10 DEGREE CANNULATED
• 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: 10988391
• MDR Text Key: 225384955
• Report Number: 3008650117-2020-00254
• Device Sequence Number: 1
• Product Code: HTY
• Combination Product (y/n): N
• Reporter Country Code: WA
• 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: 12/10/2020

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
• Device Lot Number: 260114417B
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/18/2018
• Initial Date FDA Received: 12/10/2020
• 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