MAUDE Adverse Event Report: SURGICAL SPECIALTIES CORPORATION QUILL; PDO, BARBED SUTURE, TAPER POINT

Model Number	VLP-2053
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	08/05/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A review of the device history records confirmed there were no quality issues noted throughout the incoming inspection of raw material components, manufacturing, in-process or final inspection processes.The actual device or photos were not returned for review.No sterile devices were received to date for review/testing.If samples or photos become available at a later time they will be evaluated/reviewed and the results will be included in the file.A follow-up report will be forwarded to you at that time.The needle detaching during use could be due to the suture material was not placed deep enough within the needle hole during the manufacturing process.It¿s also possible the devices are being grasped on or near the swaged end of the needle, damaging the suture material allowing the suture to break free from the needle or excessive force is used when moving the device through the trocar, exceeding the strength of the attachment/suture strength, allowing the needle to detach from the suture.The ¿precautions¿ section in the ifu for the polypropylene device 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.The surgeon should avoid unnecessary tension when running down knots, to reduce the occurrence of surface fraying and weakening of the strand.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¿.The ¿precautions¿ section in the ifu for the device 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 device/trocar used, magnified photos of the actual device/trocar used or receiving details regarding the preoperative preparation of the device(s), tools utilized to grasp the device, procedures performed or the surgeon¿s technique, a definitive root cause cannot be determined at this time.
Event or Problem Description
The surgeon says the needle broke off from the thread upon entry into abdomen through the 8mm robotic trocar during the robotic ventral hernia repair.The needle then flew across the abdomen and they couldn¿t find it.They eventually found it via an x-ray.

• Brand Name: QUILL
• Common Device Name: PDO, BARBED SUTURE, TAPER POINT
• Manufacturer (Section D): SURGICAL SPECIALTIES CORPORATION; corredor tijuana rosarito 2000; #24702-b ejido francisco villa; tijuana 22235 ; MX 22235
• MDR Report Key: 12435987
• Report Number: 3010692967-2021-00037
• Device Sequence Number: 3735592
• Product Code: NEW
• UDI-Device Identifier: 10848782004802
• UDI-Public: (01)10848782004802(17)250623(10)AAGK673
• Combination Product (Y/N): Y
• PMA/510(K) Number: K051609
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Y
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 09/07/2021
• Report Date (Section F): 08/09/2021

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: 06/23/2025
• Device Model Number: VLP-2053
• Device Catalogue Number: VLP-2053
• Device Lot Number: AAGK673
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 08/05/2021
• Device Age: 13 MO
• Event Location: Hospital
• Date Report to Manufacturer: 08/09/2021
• Type of Report(Section G): Fifteen-Day
• Initial Date Received by Manufacturer: 08/09/2021
• Initial Report FDA Received Date: 09/07/2021
• 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