MAUDE Adverse Event Report: SURGICAL SPECIALTIES CORPORATION QUILL; QUILL #2 BARBED SUTURE

Model Number RX-1066Q

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem Wound Dehiscence (1154)

Event Date 02/07/2018

Event Type  Injury  

Manufacturer Narrative

Method: the actual device was discarded by the end user.However, sterile devices from the same finished good lot were returned for testing/review.Results/conclusions: the sterile devices were visually examined and tested/measured per current requirements.There were barbs present on all of the samples and all measurements were acceptable for this size/type barbed suture device.Relevant portions of the device history record were reviewed.The product from this lot and all components utilized met current usp and surgical specialties (b)(4) requirements throughout the incoming inspection, manufacturing and final inspection process.No inventory is available from this finished good lot.- without receiving detailed information regarding the procedure performed, patient specific details, surgeon's technique, material placement in tissue, post-operative instructions and/or events that may have occurred, a definitive root cause for the dehiscence cannot be confirmed at this time.

Event Description

The surgeon reported that a patient returned with dehiscence of the incision following the use of a #2 pdo quill device.The incision was repaired without further incident.The surgeon also stated that the barbs on the devices did not appear as prominant as devices utilized in the past.No further details were obtained.

• Brand Name: QUILL
• Type of Device: QUILL #2 BARBED SUTURE
• Manufacturer (Section D): SURGICAL SPECIALTIES CORPORATION; corredor tijuana rosarito 2000; 24702-b, ejido francisco villa; tijuana 22235 ; MX 22235
• Manufacturer Contact: kelly knappenberger ; 1100 berkshire blvd.; ste 308; reading, PA 19608
• MDR Report Key: 7327375
• MDR Text Key: 102014975
• Report Number: 3010692967-2018-00005
• Device Sequence Number: 1
• Product Code: GAB
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K051609
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/09/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/09/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 11/30/2022
• Device Model Number: RX-1066Q
• Device Catalogue Number: RX-1066Q
• Device Lot Number: AACB332
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 02/07/2018
• Device Age: 4 MO
• Date Manufacturer Received: 02/08/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/17/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention