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 Break (1069)

Patient Problem Insufficient Information (4580)

Event Date 06/29/2021

Event Type  malfunction  

Manufacturer Narrative

Product evaluation confirmed the alleged failure mode. If further information is identified which would change or alter information or conclusions, a supplemental report will be filed accordingly.

Event Description

After drilling, the depth gauge was broken while attempting to measure.

• 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: victoria akinboboye ; 14445 grasslands dr.; englewood, CO 80112 ; 7207165439
• MDR Report Key: 12205084
• MDR Text Key: 264951569
• Report Number: 3008650117-2021-00098
• Device Sequence Number: 1
• Product Code: HTJ
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign
• Type of Report: Initial
• Report Date: 07/21/2021

1 Device was Involved in the Event

0 Patients were Involved in the Event:

• Date FDA Received: 07/21/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• 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: 07/15/2021

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 06/29/2021
• 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: Unkown