MAUDE Adverse Event Report: SURGICAL SPECIALTIES MÉXICO, S. DE R.L. DE C.V. 2DE14 2-0 UNDYD MONODERM 30X30; SUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID

Model Number	YA-1024Q-0
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	04/14/2021
Type of Reportable Event	Malfunction
Event or Problem Description
During a breast reduction procedure, the scrub tech noticed that a quill monoderm suture ya-1024q-0 should be a double arm suture.The package had an incorrect product inside.

• Brand Name: 2DE14 2-0 UNDYD MONODERM 30X30
• Common Device Name: SUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID
• Manufacturer (Section D): SURGICAL SPECIALTIES MÉXICO, S. DE R.L. DE C.V.; 247 station drive ne1; westwood MA 02090
• MDR Report Key: 11715545
• Report Number: 11715545
• Device Sequence Number: 17150382
• Product Code: GAM
• UDI-Device Identifier: 00848782021970
• UDI-Public: (01)00848782021970(17)251004(10)AAGV679
• Combination Product (Y/N): N
• Initial Reporter State: MT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 04/15/2021
• Report Date (Section F): 04/20/2021

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: No Information
• Device Model Number: YA-1024Q-0
• Device Lot Number: AAGV679
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 04/23/2021
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/23/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Date Report Sent to FDA: 04/20/2021