MAUDE Adverse Event Report: EXACTECH, INC. OPTECURE 1CC RT; BONE GRAFTING MATERIAL, HUMAN SOURCE

Model Number	1(352)377-1140
Medical Device Problem Code	Contamination /Decontamination Problem (2895)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/22/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Additional information, including the product investigation, will be submitted within 30 days of receipt.
Event or Problem Description
As reported, the doctor found an unidentified white solid inside the product when he was about to use it.Images received.The device will be return.

• Brand Name: OPTECURE 1CC RT
• Common Device Name: BONE GRAFTING MATERIAL, HUMAN SOURCE
• Manufacturer (Section D): EXACTECH, INC.; 2320 nw 66 court; gainesville FL 32653
• Manufacturer (Section G): EXACTECH, INC.; 2320 nw 66 court; gainesville FL 32653
• Manufacturer Contact: michael crader
• MDR Report Key: 18944457
• Report Number: 1038671-2024-00591
• Device Sequence Number: 2969749
• Product Code: NUN
• UDI-Device Identifier: 10885862094780
• UDI-Public: 10885862094780
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K040755
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 03/20/2024

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: 1(352)377-1140
• Device Catalogue Number: 650-00-01
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/22/2024
• Initial Report FDA Received Date: 03/20/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/12/2022
• 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 Sex: Unknown