MAUDE Adverse Event Report: PARAGON 28, INC BABY GORILLA/GORILLA PLATING SYSTEM; K-WIRE, SINGLE ENDED TROCAR TIP, SMOOTH, 1.6 X 100 MM

Model Number P99-192-1610

Device Problem Detachment of Device or Device Component (2907)

Patient Problem Foreign Body In Patient (2687)

Event Date 03/07/2022

Event Type  malfunction  

Event Description

A 1.6 k-wire broke during a procedure leaving a sliver in the patient.The surgeon checked the surface where the piece was located and decided to leave the k-wire piece in the patient as it was not prominent and not in contact wiht any implant.

• Brand Name: BABY GORILLA/GORILLA PLATING SYSTEM
• Type of Device: K-WIRE, SINGLE ENDED TROCAR TIP, SMOOTH, 1.6 X 100 MM
• 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: 14027571
• MDR Text Key: 290937128
• Report Number: 3008650117-2022-00033
• Device Sequence Number: 1
• Product Code: HXI
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Distributor
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 04/06/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/06/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: P99-192-1610
• Device Catalogue Number: P99-192-1610
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/08/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Sex: Male
• Patient Weight: 64 KG