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 07/29/2020

Event Type  malfunction  

Manufacturer Narrative

The device history records for lot number 9154536 were reviewed.All parts but 1 were noted to be within specification and not related to the depth gauge breakage.Visual observation of the instrument confirmed the depth gauge broken into pieces.If any further information is found which would change or alter any conclusions or information, a supplemental report will be filed accordingly.

Event Description

A pargon 28 depth gauge plate screw, 70mm screw was reported broken after being washed.The needle of the device is snapped off completely.It was reported that the instrument was not broken in surgery.

• 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
• MDR Report Key: 11599605
• MDR Text Key: 244390237
• Report Number: 3008650117-2021-00073
• Device Sequence Number: 1
• Product Code: HTJ
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K190365
• 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: 03/31/2021

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: 9154536
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/09/2020
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/01/2020
• Initial Date FDA Received: 03/31/2021
• 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: Reuse
• Patient Sequence Number: 1