MAUDE Adverse Event Report: CP MEDICAL DARBY NON ABSORBABLE SILK SUTURE; SILK NON ABSORBABLE SUTURE

Model Number	9505531
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	03/25/2021
Type of Reportable Event	Malfunction
Event or Problem Description
Dr.Was placing sutures for a periodontal procedure.The sutures were on the table.As the dr.Went to get one of the sutures it was noticed that the needle was not attached to the suture.As the suture could not be immediately found the patient was sent to the emergency room out of an abundance of caution.The needle was subsequently found on the floor of the room where the procedure was performed.

• Brand Name: DARBY NON ABSORBABLE SILK SUTURE
• Common Device Name: SILK NON ABSORBABLE SUTURE
• Manufacturer (Section D): CP MEDICAL; 1775 corporate dr; suite 150; norcross GA 30093 2960
• MDR Report Key: 11700359
• Report Number: 3012164473-2021-00001
• Device Sequence Number: 3721747
• Product Code: GAP
• UDI-Device Identifier: 00889813003343
• UDI-Public: (01)00889813003343
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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): Unknown
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 04/21/2021

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 Expiration Date: 04/30/2024
• Device Model Number: 9505531
• Device Lot Number: 190516-53
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/14/2021
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/25/2021
• Initial Report FDA Received Date: 04/21/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 45 YR