MAUDE Adverse Event Report: SURGICAL SPECIALTIES MEXICO QUILL; QUILL BARBED SUTURE DEVICE

Model Number RA-1065Q

Device Problem Break (1069)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  Injury  

Manufacturer Narrative

The actual devices were not returned for review/testing.Sealed, sterile samples from the reported lot were received for visual review and testing.No defects were observed on any of the devices.The suture was dimensionally measured and reviewed for barb angle, depth and placement on the suture strand.The samples met all current requirements for item ra-1065q.The sutures were tensile tested according to our procedures and met usp requirements for #2 pdo material.The root cause for the suture breaking post-operative is difficult to determine without receiving samples of the actual device(s) to examine under a microscope, magnified photographs of the actual device(s), photos of the dehisced incision(s), details regarding the pre-operative preparation of the device(s), procedure performed, surgeon¿s technique, patient specifics (ex.Weight, age, health status (diabetic, obese, poor circulation), post-operative instructions not followed or events that may have occurred that resulted in injury to the incision or suture failing (ex.Fall, strain).

Event Description

Two (2) cases of sutures breaking post-operative were reported by the operating facility.Patients returned to have incisions repaired (total knee).No permanent tissue damage or patient injury was reported.

• Brand Name: QUILL
• Type of Device: QUILL BARBED SUTURE DEVICE
• Manufacturer (Section D): SURGICAL SPECIALTIES MEXICO; corredor tijuana-rosarito 2000; ejido francisco villa; tijuana 22235 ; MX 22235
• Manufacturer Contact: kelly knappenberger ; 1100 berkshire blvd.; ste 308; reading, PA 19608
• MDR Report Key: 8570404
• MDR Text Key: 143739117
• Report Number: 3010692967-2019-00014
• Device Sequence Number: 1
• Product Code: GAB
• Combination Product (y/n): Y
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Nurse Practitioner
• Type of Report: Initial
• Report Date: 01/01/2005,05/01/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/01/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2024
• Device Model Number: RA-1065Q
• Device Catalogue Number: RA-1065Q
• Device Lot Number: AADO020
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Report Sent to FDA: 01/01/2005
• Distributor Facility Aware Date: 04/04/2019
• Device Age: 4 MO
• Event Location: Hospital
• Date Report to Manufacturer: 04/04/2019
• Date Manufacturer Received: 04/04/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention