MAUDE Adverse Event Report: PARAGON 28, INC. BABY GORILLA/GORILLA PLATING SYSTEM; MORSELIZING BONE GRAFT HARVESTER

Model Number P99-930-2108

Device Problems Patient-Device Incompatibility (2682); Device-Device Incompatibility (2919); Difficult to Advance (2920)

Patient Problem Burn, Thermal (2530)

Event Date 10/18/2019

Event Type  Injury  

Manufacturer Narrative

Identifying information, such as the lot number of the device was not reported to paragon 28.Case information including related patient information was not provided by the initial reporter.Devices are not expected to be returned for the manufacturer review/investigation.If any further information is found which would change or alter any conclusions or information, a supplemental report will be filed accordingly.

Event Description

It was reported that the patient underwent a primary fusion surgical procedure that utilized paragon 28 morselizing bone graft harvester, ao, 8mm.The bone graft harvester burned the patient's bone while harvesting from the left calcaneus.It was reported that a 2.3 x 150 mm k-wire single ended trocar was used however, the complaint initiator mentioned that k-wire did not make a large enough entrance hole.Alleging that the usage of the k-wire made it difficult to push through which then resulted into the burning of the bone graft.

• Brand Name: BABY GORILLA/GORILLA PLATING SYSTEM
• Type of Device: MORSELIZING BONE GRAFT HARVESTER
• 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: 11356980
• MDR Text Key: 232801958
• Report Number: 3008650117-2021-00032
• Device Sequence Number: 1
• Product Code: HRS
• Combination Product (y/n): N
• Reporter Country Code: US
• 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: 02/21/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/22/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: P99-930-2108
• Device Catalogue Number: P99-930-2108
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/21/2019
• 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
• Treatment: 2.3 X 150 MM K-WIRE SINGLE ENDED TROCAR; DISPOSABLE TREPHINE; REUSABLE DOOR
• Patient Outcome(s): Required Intervention