MAUDE Adverse Event Report: SURGICAL SPECIALTIES CORPORATION QUILL; QUILL PDO 1, 30CM, VIOLET, 1/2 CIR TAPER

Model Number	VLP-2015
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/27/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A review of the device history records for the finished good device and components confirmed the product met requirements at time of release; no quality issues were noted throughout the incoming inspection, manufacturing, in-process or final inspection process.The actual device/broken needle was not returned or photographed so an evaluation could not be performed.Sterile devices were available from the same lot, visually reviewed and tested.No defects or abnormalities were observed.The needles met specification for a 1/2 circle, taper point needle.The bending, fracturing, breaking of a needle can occur when needles are gripped with a needle holder, forceps, surgical instrument on or near the swaged area or near the tip of the device, when excessive force is applied, when the device(s) are used in applications involving tortuous tissue or with a needle tip design that may not be appropriate for the specific tissue or procedure.The ¿precautions¿ section in the ifu for the devices states: ¿care should be taken to avoid damage when handling.Avoid crushing or crimping the suture material with surgical instruments such as needle holders and forceps.To avoid damaging needle points and swage areas, grasp the needle in an area one-third (1/3) to one-half (1/2) of the distance from the swaged end to the point".Without reviewing the actual needle/broken piece, receiving photos of the broken device or receiving detailed information regarding the preoperative preparation of the device, tools utilized to grasp the device, procedure performed and/or the surgeon''s technique, a definitive root cause cannot be confirmed at this time.
Event or Problem Description
The needle tip broke off of the device during a robotic assisted radical prostatectomy rarp procedure.The tip was flushed from the site; needle was completely accounted for and removed from the site without further incident.No patient injury was reported.

• Brand Name: QUILL
• Common Device Name: QUILL PDO 1, 30CM, VIOLET, 1/2 CIR TAPER
• Manufacturer (Section D): SURGICAL SPECIALTIES CORPORATION; corredor tijuana rosarito 2000; #24702-b ejido franisco villa; tijuana 22235 ; MX 22235
• MDR Report Key: 11342765
• Report Number: 3010692967-2021-00005
• Device Sequence Number: 17333354
• Product Code: NEW
• UDI-Device Identifier: 10848782020864
• UDI-Public: (01)10848782020864(17)250531(10)AAFZ327
• Combination Product (Y/N): Y
• PMA/510(K) Number: K051609
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 02/18/2021
• Report Date (Section F): 01/27/2021

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: 03/31/2025
• Device Model Number: VLP-2015
• Device Catalogue Number: VLP-2015
• Device Lot Number: AAFZ327
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 01/27/2021
• Device Age: 10 MO
• Event Location: Hospital
• Date Report to Manufacturer: 01/27/2021
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/27/2021
• Initial Report FDA Received Date: 02/18/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention