MAUDE Adverse Event Report: SURGICAL SPECIALTIES CORPORATION QUILL; PDO,VIO,3-0,TAPER POINT, UNI-DIRECTIONAL

Model Number JVLP-2022

Device Problem Detachment of Device or Device Component (2907)

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

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.No additional complaints have been reported for this lot.No samples or photographs of the actual devices were returned for evaluation.No retained samples were available for review.If samples become available at a later time, the devices will be reviewed, tested and the results will be included in the file.A revised response letter will be forwarded to you at that time.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.Pdo suture material can change color, become brittle; break easily if exposed more than the recommended time for this type of material.Surgical specialties documents the exposure time throughout the inspection and manufacturing processes to prevent over-exposure prior to packaging the devices.The exposure time for this lot was reviewed and met all current criteria.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 receiving the actual device(s) for review, receiving sterile device(s) to review/test, receiving magnified photographs of the used device(s) for review, or receiving detailed information regarding the shipping, storage and handling of the devices, exposure time prior to the procedure, method utilized to remove the device(s) from the packaging, preoperative preparation of the device, tools utilized to grasp the device(s), size of the trocar used compared to the needle size, procedure details or the surgeon¿s experience or technique, a definitive root cause cannot be determined at this time.

Event Description

About 10 minutes after starting to use the device, the needle detached from the suture.The needle fell into the body and had to be retrieved with a forceps.The swaged end of the needle was not broken.The patient sustained no injury.The procedure was completed without further incident.

• Brand Name: QUILL
• Type of Device: PDO,VIO,3-0,TAPER POINT, UNI-DIRECTIONAL
• 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: 15642567
• MDR Text Key: 306830828
• Report Number: 3010692967-2022-00048
• Device Sequence Number: 1
• Product Code: NEW
• UDI-Device Identifier: 10848782034748
• UDI-Public: (01)10848782034748(17)270109(10)C210LXX
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K051609
• Number of Events Reported: 123
• Summary Report (Y/N): Y
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative,Distributor
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 10/19/2022,10/20/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/20/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: JVLP-2022
• Device Lot Number: C210LXX
• Was the Report Sent to FDA?: No
• Device Age: 7 MO
• Event Location: Hospital
• Date Report to Manufacturer: 10/19/2022
• Date Manufacturer Received: 10/19/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/09/2022
• 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; Other