MAUDE Adverse Event Report: PARAGON28, INC JAWS NITINOL STAPLE SYSTEM

Model Number	P72-020-2020-S
Medical Device Problem Codes	Unintended Movement (3026); Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/04/2024
Type of Reportable Event	Malfunction
Event or Problem Description
The metal radiopaque piece on the inside of the drill guide had gotten stuck and welded itself onto the drill during the procedure.This happened on two staple kits.The surgery was successfully completed but was delayed by approximately 3 minutes.This is report 2 of 2.

• Brand Name: JAWS NITINOL STAPLE SYSTEM
• Common Device Name: JAWS NITINOL STAPLE SYSTEM
• Manufacturer (Section D): PARAGON28, INC; 14445 grasslands dr; englewood CO 80112
• Manufacturer (Section G): PARAGON28, INC; 14445 grasslands dr; englewood CO 80112
• Manufacturer Contact: kate vang ; 14445 grasslands dr; englewood, CO 80112
• MDR Report Key: 18572479
• Report Number: 3008650117-2024-00002
• Device Sequence Number: 18129128
• Product Code: JDR
• UDI-Device Identifier: 00889795124227
• UDI-Public: 00889795124227
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K230550
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 01/24/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: P72-020-2020-S
• Device Catalogue Number: P72-020-2020-S
• Device Lot Number: MP2422307
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/11/2024
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/04/2024
• Initial Report FDA Received Date: 01/24/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/08/2023
• 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
• Patient Age: 65 YR
• Patient Sex: Male