MAUDE Adverse Event Report: SURGICAL SPECIALTIES CORPORATION QUILL; 2-0, 20CM, VIOLET, TAP PNT, 17MM

Model Number	VLM-2005
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/26/2021
Type of Reportable Event	Malfunction
Additional 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 sterile samples were available for testing/review.No retained samples were available for testing/review.The actual needle was not located and the suture was discarded.If samples become available at a later date, they will be tested/reviewed and the results will be included in the file.A follow-up report will be submitted at that time.The needle detaching during use or when removing through the trocar 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 utilized, exceeding the strength of the attachment/suture strength, allowing the needle to pull free from the suture.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.The surgeon should avoid unnecessary tension 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¿.
Event or Problem Description
A quill needle became loose during the procedure (radical prostatectomy).The needle device is still missing.Not found in the patient.It is not known if the device loosened while removing through the trocar.No injury reported.
Additional Manufacturer Narrative
Without receiving the actual device for examination under magnification, receiving magnified photos of the actual device for review or receiving detailed information regarding the preoperative preparation of the device, tools utilized to grasp the device, type/size trocar used with this size needle, procedure performed or the surgeon's technique, a definitive root cause cannot be determined at this time.

• Brand Name: QUILL
• Common Device Name: 2-0, 20CM, VIOLET, TAP PNT, 17MM
• Manufacturer (Section D): SURGICAL SPECIALTIES CORPORATION; corredor tijuana rosarito 2000; #24702-b ejido francisco villa; tijuana 22235 ; MX 22235
• MDR Report Key: 12360179
• Report Number: 3010692967-2021-00035
• Device Sequence Number: 12044872
• Product Code: GAM
• UDI-Device Identifier: 10848782020482
• UDI-Public: (01)10848782020482(17)260109(10)AAHF850
• Combination Product (Y/N): Y
• PMA/510(K) Number: K072028
• 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: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 08/24/2021
• Report Date (Section F): 07/29/2021

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: 01/09/2026
• Device Model Number: VLM-2005
• Device Catalogue Number: VLM-2005
• Device Lot Number: AAHF850
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 07/26/2021
• Device Age: 5 MO
• Event Location: Hospital
• Date Report to Manufacturer: 07/29/2021
• Type of Report(Section G): Fifteen-Day
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided; Not provided
• Initial Report FDA Received Date: 08/24/2021
• Supplement Report FDA Received Date: 08/24/2021; 08/25/2021
• 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
• Patient Age: 68 YR