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

Catalog Number P99-150-0014

Device Problems Break (1069); Unintended Movement (3026)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 04/20/2022

Event Type  malfunction  

Event Description

The depth gauge tip was broken.

Manufacturer Narrative

Limited information.

Manufacturer Narrative

Product received and evaluation required updates and additions to this report.B5: updated to state - product was returned and evaluated.Evaluation of the depth gauge identified its probe was bent and not broken.D4: lot number added.D9: available for evaluation.G6: follow up 1.H2 & h3: evaluated, evaluation attached.H6: medical device problem code: 3026.Component code: 918.Type of investigation: 4109, 4111, 3331 (adding 3331 to existing codes).Investigation conclusions: 4315.

Event Description

Product was returned and evaluated.Evaluation of the depth gauge identified its probe was bent and not broken.

• 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: 14463988
• MDR Text Key: 293275099
• Report Number: 3008650117-2022-00057
• 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,Followup
• Report Date: 05/20/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/20/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: P99-150-0014
• Device Lot Number: 9155057
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 04/20/2022
• 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: Unknown
• Patient Sequence Number: 1