MAUDE Adverse Event Report: SURGICAL SPECIALTIES CORPORATION MEXICO QUILL; QUILL PDO, 1, VIOLET TAPER UNI-DIRECTIONAL

Model Number VLP-2015

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

Patient Problem Insufficient Information (4580)

Event Date 05/06/2021

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 was not returned for review.No retained samples were available 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 samples from the reported lot were returned for visual review and testing.No defects were observed on the needles, suture or the attachments.All devices met the current specification including the needle pull requirements for a 1 pdo barbed device.The needle detaching during use most likely resulted from the interaction of specific procedural related stress in contrast to the strength of the attachment.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 component.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¿.Pdo suture material can 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 particular lot was reviewed and met all current criteria.Without reviewing the actual reported device, receiving magnified photos of the actual device or receiving detailed information regarding the shipping, handling and storage of the device(s), exposure time prior to use, pre-operative preparation of the device(s), 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 detached from the suture and fell into the abdominal cavity of the patient during a laparoscopic miomectomy procedure.The entire device was retrieved and removed from the surgical field without further incident.Prolonged surgical time was reported.

• Brand Name: QUILL
• Type of Device: QUILL PDO, 1, VIOLET TAPER UNI-DIRECTIONAL
• Manufacturer (Section D): SURGICAL SPECIALTIES CORPORATION MEXICO; 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: 11971475
• MDR Text Key: 271890370
• Report Number: 3010692967-2021-00020
• Device Sequence Number: 1
• Product Code: NEW
• UDI-Device Identifier: 10848782020864
• UDI-Public: (01)10848782020864(17)250817(10)AAGR062
• Combination Product (y/n): Y
• Reporter Country Code: LH
• PMA/PMN Number: K051609
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 05/18/2021,06/09/2021

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
• Device Operator: Health Professional
• Device Model Number: VLP-2015
• Device Lot Number: AAGR062
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 05/18/2021
• Device Age: 8 MO
• Event Location: Hospital
• Date Report to Manufacturer: 05/18/2021
• Initial Date Manufacturer Received: 05/18/2021
• Initial Date FDA Received: 06/09/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/18/2020
• 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