MAUDE Adverse Event Report: SURGICAL SPECIALTIES MÉXICO, S. DE R.L. DE C.V. 2-0 UNI MONODERM 60CM; SUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID

Model Number	VLM-2002
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/21/2021
Type of Reportable Event	Malfunction
Event or Problem Description
Quill suture vlm-2002 , lot # aahu020 , suture material was smooth , no barbs felt.Needles fell off suture material.No patient involvement.Suture material removed from room , boxes with same lot #taken out of inventory.There was no patient involvement.Packages were removed from room when issue was discovered.

• Brand Name: 2-0 UNI MONODERM 60CM
• 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: 12576290
• Report Number: 12576290
• Device Sequence Number: 11577050
• Product Code: GAM
• UDI-Device Identifier: 00848782020423
• UDI-Public: (01)00848782020423
• Combination Product (Y/N): N
• Initial Reporter State: RI
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 09/21/2021
• Report Date (Section F): 09/21/2021

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: Other
• Device Model Number: VLM-2002
• Device Lot Number: AAHU020
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 10/05/2021
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 10/05/2021
• Patient Sequence Number: 1
• Date Report Sent to FDA: 09/21/2021