MAUDE Adverse Event Report: PARAGON 28, INC MONSTER SCREW SYSTEM

Model Number P20-120-028S

Device Problems Improper or Incorrect Procedure or Method (2017); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Muscle/Tendon Damage (4532)

Event Date 09/30/2020

Event Type  Injury  

Manufacturer Narrative

(b)(4).

Event Description

3 months postoperatively the patient lost function of the fhl tendon.Removal of the akin osteotomy screw did not restore fhl function.After removal of this screw the tendon was found to be 90 percent attenuated at the level of the base of the proximal phalanx/mtp joint.Tendon was repaired with fractional lengthening.

Manufacturer Narrative

Per the surgical technique this implant placement has no impact on the function of the fhl tendon.User error was identified associated either with implant placement or incorrect selection of implant size.

Event Description

Revision surgery conducted due to loss of function of fhl tendon identified 3 months post-op.

• Brand Name: MONSTER SCREW SYSTEM
• Type of Device: SCREW
• Manufacturer (Section D): PARAGON 28, INC; 14445 grasslands dr; englewood CO 80112
• Manufacturer Contact: jenny conger ; 14445 grasslands dr; englewood, CO 80112 ; 7203721212
• MDR Report Key: 16156608
• MDR Text Key: 307265037
• Report Number: 3008650117-2023-00007
• Device Sequence Number: 1
• Product Code: HWC
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Study,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 01/13/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/13/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: P20-120-028S
• Device Catalogue Number: P20-120-028S
• Device Lot Number: PA6976/56
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/15/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/19/2017
• 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): Required Intervention
• Patient Age: 17 YR
• Patient Sex: Female
• Patient Weight: 62 KG