MAUDE Adverse Event Report: PARAGON 28, INC BABY GORILLA/GORILLA PLATING SYSTEM; DEPTH GAUGE PLATE SCREW, 70MM SCREW

Model Number P99-150-0014

Device Problem Fracture (1260)

Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 01/20/2022

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Preferred term: unknown.Limited information is available and it is unknown if the product malfunction occurred during a procedure.

Event Description

Limited information - a depth gauge with a broken tip was found while conducting stock inventory.

• Brand Name: BABY GORILLA/GORILLA PLATING SYSTEM
• Type of Device: DEPTH GAUGE PLATE SCREW, 70MM 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: 13545902
• MDR Text Key: 286502651
• Report Number: 3008650117-2022-00024
• Device Sequence Number: 1
• Product Code: HTJ
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 02/16/2022

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: P99-150-0014
• Device Catalogue Number: P99-150-0014
• Device Lot Number: 9152814
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/31/2022
• Initial Date Manufacturer Received: 01/20/2022
• Initial Date FDA Received: 02/16/2022
• Was Device Evaluated by Manufacturer?: Yes
• 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