MAUDE Adverse Event Report: SURGICAL SPECIALTIES CORPORATION QUILL; PDO VIOLET 2-0 15CM 1/2C TAPER 17MM

Model Number VLP-2022

Device Problems Detachment of Device or Device Component (2907); Device Fell (4014)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/24/2022

Event Type  malfunction  

Manufacturer Narrative

A review of the device history records for the reported finished good lot and raw material components identified no quality issues during the incoming, manufacturing, in-process or final inspection processes.The actual device(s) or photos were not returned for review.If samples become available at a later time they will be reviewed/tested and the results will be included in the file.A revised report will be submitted at that time.Sterile devices from the same finished good lot were returned, visually reviewed and tested.No defects or abnormalities were observed on the needles, attachments or the suture material.The devices met the current specifications including the usp needle pull requirements for a 2-0 pdo barbed device.A potential root cause for a needle detaching when slightly tugged during the procedure could be that the suture was not fully inserted 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, allowing the suture to break free from the needle or excessive force is utilized during the process, exceeding the strength of the attachment, allowing the needle to pull free from the suture.The ¿precautions¿ section in the ifu for the pdo 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 receiving the actual device(s) for review, receiving magnified photos of the device(s) for review or receiving detailed information regarding the preoperative preparation of the device, tools utilized to grasp the device, procedure performed or the surgeon¿s technique, a definitive root cause cannot be determined at this time.

Event Description

The needle came off the thread several times when the nfc was pulled out through the trocar after closure of the peritoneum during a tap.In the process, the needle came off the thread and fell into the abdomen.The needle was recovered.No injury was reported.

• Brand Name: QUILL
• Type of Device: PDO VIOLET 2-0 15CM 1/2C TAPER 17MM
• Manufacturer (Section D): SURGICAL SPECIALTIES CORPORATION; corredor tijuana rosarito 2000; #24702-b ejido francisco villa; tijuana 22235 ; MX 22235
• Manufacturer Contact: luis knappenberger ; 1100 berkshire blvd.; ste 308; reading, PA 19608
• MDR Report Key: 14152154
• MDR Text Key: 298952627
• Report Number: 3010692967-2022-00010
• Device Sequence Number: 1
• Product Code: NEW
• UDI-Device Identifier: 10848782023674
• UDI-Public: (01)10848782023674(17)260703(10)B803ALK
• Combination Product (y/n): N
• Reporter Country Code: SP
• PMA/PMN Number: K051609
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Distributor
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 03/24/2022,04/19/2022

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
• Device Operator: Health Professional
• Device Model Number: VLP-2022
• Device Catalogue Number: VLP-2022
• Device Lot Number: B803ALK
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 03/24/2022
• Device Age: 7 MO
• Event Location: Hospital
• Date Report to Manufacturer: 03/24/2022
• Initial Date Manufacturer Received: 03/24/2022
• Initial Date FDA Received: 04/19/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/04/2021
• 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
• Patient Sex: Female