MAUDE Adverse Event Report: PARAGON 28, INC BABY GORILLA/GORILLA PLATING SYSTEM; BABY GORILLA SCREW

Model Number	P50-053-2528
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/27/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
On (b)(6) 2023, two baby gorilla locking screws (2.0mm x 36mm & 2.5mm x 28mm) were reported broke during a female patient's navicular fracture revision on october 27, 2023.It was the first set of screws that were placed in the patient who was a college athlete.The screws were extracted using a special screw removal kit and discarded.The surgery was completed successfully but was postponed for more than 30 minutes.This is report 2 of 2.
Additional Manufacturer Narrative
Product evaluation: the device was not returned.Potential cause: the cause of the damage is most likely due to hard bone when the screw was inserted but cannot be determined since there is no information available regarding how the screw was being used or handled at the time of the damage.Device history record review: since the lot number was not provided, therefore a dhr review could not be conducted.A supplemental report will be submitted if new information is received that changes the information provided in this report.
Event or Problem Description
Two baby gorilla locking screws (2.0mm x 36mm & 2.5mm x 28mm) were reported broken during a navicular fracture revision.It was the first set of screws that were placed in the patient.The screws were extracted using a special screw removal kit and discarded.The surgery was completed successfully but was postponed for more than 30 minutes.This is report 2 of 2.
Additional Manufacturer Narrative
Additional information, d4: udi.Correction: b5.

• Brand Name: BABY GORILLA/GORILLA PLATING SYSTEM
• Common Device Name: BABY GORILLA SCREW
• Manufacturer (Section D): PARAGON 28, INC; 14445 grasslands dr; englewood CO 80112
• Manufacturer Contact: 14445 grasslands dr.; englewood, CO 80112
• MDR Report Key: 18212610
• Report Number: 3008650117-2023-00122
• Device Sequence Number: 12373250
• Product Code: HWC
• UDI-Device Identifier: 00889795019073
• UDI-Public: 00889795019073
• Combination Product (Y/N): N
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/30/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: P50-053-2528
• Device Catalogue Number: P50-053-2528
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/27/2023
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 11/27/2023
• Supplement Report FDA Received Date: 01/30/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Female