MAUDE Adverse Event Report: CP MEDICAL SILK SUTURE; SUTURE, NONABSORBABLE, SILK

Model Number	734S-DAR
Medical Device Problem Code	Material Integrity Problem (2978)
Health Effect - Clinical Code	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	04/16/2024
Type of Reportable Event	Malfunction
Event or Problem Description
A complaint was received concerning part number 734s-dar.Lot 221101-56, size 4/0 silk swage suture.According to the report, the suture detached from the needle during surgery.No injuries or delay in the surgical procedure was reported by the clinic.

• Brand Name: SILK SUTURE
• Common Device Name: SUTURE, NONABSORBABLE, SILK
• Manufacturer (Section D): CP MEDICAL; 1775 corporate dr; suite 150; norcross GA 30093 2960
• Manufacturer (Section G): CP MEDICAL; 1775 corporate dr; suite 150; norcross GA 30093 2960
• Manufacturer Contact: alfredo ferrer ; 1775 corporate dr; suite 150; norcross, GA 30093-2960
• MDR Report Key: 19287028
• Report Number: 3012164473-2024-00001
• Device Sequence Number: 7734700
• Product Code: GAP
• UDI-Device Identifier: 00889813003176
• UDI-Public: (01)00889813003176
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K001184
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Dentist
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 05/09/2024

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?: No
• Operator of Device: Health Professional
• Device Model Number: 734S-DAR
• Device Catalogue Number: 9505522
• Device Lot Number: 221101-56
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/01/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/16/2024
• Initial Report FDA Received Date: 05/10/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/06/2022
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown