MAUDE Adverse Event Report: PARAGON 28, INC. BABY GORILLA/GORILLA PLATING SYSTEM; MTP SPIN GUARD¿ FEMALE REAMER, 19MM

Model Number P01-900-1902

Device Problems Use of Device Problem (1670); Device Handling Problem (3265)

Patient Problems Laceration(s) (1946); Skin Tears (2516)

Event Date 09/22/2022

Event Type  Injury  

Manufacturer Narrative

No allegation of device deficiency or device malfunction is associated with this serious injury.User error was reported/confirmed as the device was not used as intended per the surgical technique guide and prompts by the sales representative present during the case.The health care provider admitted failure to use the safety guard during use of this device.Health care provider is said to be recovering as expected from the injury.

Event Description

Health care provider reamed his thumb during joint preparation; serious injury sustained.

• Brand Name: BABY GORILLA/GORILLA PLATING SYSTEM
• Type of Device: MTP SPIN GUARD¿ FEMALE REAMER, 19MM
• 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: 15557026
• MDR Text Key: 301336683
• Report Number: 3008650117-2022-00120
• Device Sequence Number: 1
• Product Code: HTO
• Combination Product (y/n): N
• Reporter Country Code: AS
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative,Distributor
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 10/06/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/06/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: P01-900-1902
• Device Catalogue Number: P01-900-1902
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/29/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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
• Patient Outcome(s): Required Intervention