MAUDE Adverse Event Report: SURGENTEC, LLC GRAFTGUN CARTRIDGE KT; PISTON SYRINGE

Model Number	GG-K-1000
Medical Device Problem Code	Problem with Sterilization (1596)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/29/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Na.
Event or Problem Description
Rep sent in a usage sheet with a case date on (b)(6) 2025, which included the gg-k-1000 which had an expiration date of january 27th, 2025.The rep also stated that this was the sixth case of the day so when she read out the expiration dates, no one noticed that the expiry date had passed.At the time of surgery, it did not cause any patient harm during the case.The patient did not stay under anesthesia longer than initially required.

• Brand Name: GRAFTGUN CARTRIDGE KT
• Common Device Name: PISTON SYRINGE
• Manufacturer (Section D): SURGENTEC, LLC; 911 clint moore rd; boca raton FL 33487
• Manufacturer (Section G): SURGENTEC, LLC; 911 clint moore rd; boca raton FL 33487
• Manufacturer Contact: gui pires ; 911 clint moore rd; boca raton, FL 33487 ; 5619907882
• MDR Report Key: 21462077
• Report Number: 3012495575-2025-00001
• Device Sequence Number: 18189880
• Product Code: FMF
• UDI-Device Identifier: 00858406007433
• UDI-Public: 00858406007433
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K180937
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 02/20/2025

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
• Device Expiration Date: 01/27/2025
• Device Model Number: GG-K-1000
• Device Catalogue Number: GG-K-1000
• Device Lot Number: C2458821A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/30/2025
• Initial Report FDA Received Date: 02/25/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Sex: Unknown