MAUDE Adverse Event Report: SURGICAL SPECIALTIES CORPORATION QUILL; 2-0 UNI MONODERM 20CM

Model Number	VLM-2005
Medical Device Problem Code	Separation Problem (4043)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported there was a needle and thread separation during a surgical procedure.In one case of a tapp procedure, the needle separated and got lost in the body cavity, which resulted in a prolonged duration of the procedure.This is one of two devices that were reported.It is not certain with which device the event occurred.Reference complaint (b)(4).
Additional Manufacturer Narrative
A review of the device history records for the reported finished good lot and raw material components was performed and no quality issues were identified.Sterile samples from the reported lot were not returned for visual review and testing.The actual devices or magnified photos were not returned for review.If samples or photos become available at a later time, they will be reviewed and tested and the results will be included in the file.A follow-up report will be submitted at that time.A potential root cause for a needle detaching when slightly tugged during a procedure could be that the suture was not fully inserted within the end of the needle during the manufacturing process.It¿s also possible the device(s) are being grasped on or near the swaged end, damaging the suture, allowing it 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¿.Without reviewing the finished good lot number to review manufacturing records, receiving the actual reported device(s), receiving magnified photos of the actual devices, or receiving detailed information regarding the method utilized to remove the device from the packaging, preoperative preparation of the device, tools utilized to grasp the devices, details of the 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 UNI MONODERM 20CM
• Manufacturer (Section D): SURGICAL SPECIALTIES CORPORATION; corredor tijuana rosarito 20; #24702 b; tijuana baja california 22235 ; MX 22235
• Manufacturer (Section G): SURGICAL SPECIALTIES CORPORATION; 247 station drive; westwood 02090
• Manufacturer Contact: virnalisa cobacha ; corredor tijuana-rosarito 2000 #24702b; ejido francisco villa; tijuana 22235 ; MX 22235
• MDR Report Key: 19470857
• Report Number: 3010692967-2024-00037
• Device Sequence Number: 3554476
• Product Code: GAM
• UDI-Device Identifier: 10848782020482
• UDI-Public: (01)10848782020482(17)281028(10)DA25JHC
• Combination Product (Y/N): N
• Initial Reporter Country: PL
• PMA/510(K) Number: K141778
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 06/05/2024
• Report Date (Section F): 05/20/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: VLM-2005
• Device Lot Number: DA25JHC
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Report to Manufacturer: 05/20/2024
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/20/2024
• Initial Report FDA Received Date: 06/05/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/30/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown