MAUDE Adverse Event Report: SURGICAL SPECIALTIES CORPORATION QUILL; T9 #0 UNI PDO VLD 30CM

Model Number	VLP-1002
Medical Device Problem Codes	Detachment of Device or Device Component (2907); Separation Problem (4043)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	07/28/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
On august 02, 2024 it was reported that on (b)(6) 2024 during a surgical procedure the needle channel broke leading to the needle falling into the patient.The surgeon searched for the needle for over an hour and could not locate it.No additional patient consequences were reported.
Additional Manufacturer Narrative
It was reported the needle channel broke, the needle became detached and fell into the patient.Surgical intervention was required to search for the needle causing a delay in the procedure.It was reported the loose needle was not found and was potentially left in the patient.No other information has been provided to date.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.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.However, there are numerous other circumstances that can adversely affect the strength and durability of a suture/needle attachment including but not limited to the misalignment of the suture within the end of the needle, the suture material not placed deep enough within the end of the needle and/or if end is not crimped with enough force to form a secure grip onto the suture material.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 ¿adverse reactions¿ section in the ifu for the device states, "broken needles may result in extended or additional surgeries or residual foreign bodies.Without reviewing the actual reported device(s) 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: T9 #0 UNI PDO VLD 30CM
• Manufacturer (Section D): SURGICAL SPECIALTIES CORPORATION; corredor tijuana rosarito 2000; #24702 b; tijuana baja california 22235 ; MX 22235
• Manufacturer (Section G): SURGICAL SPECIALTIES CORPORATION; 247 station drive; suite ne1; westwood
• Manufacturer Contact: virnalisa cobacha ; corredor tijuana-rosarito 2000 #24702b; ejido francisco villa; tijuana
• MDR Report Key: 20050608
• Report Number: 3010692967-2024-00065
• Device Sequence Number: 7896163
• Product Code: NEW
• UDI-Device Identifier: 10848782020604
• UDI-Public: (01)10848782020604(17)280827(10)D828CYS
• Combination Product (Y/N): N
• PMA/510(K) Number: K132268
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility,Company Representative,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 08/23/2024

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: VLP-1002
• Device Lot Number: D828CYS
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/02/2024
• Initial Report FDA Received Date: 08/23/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/29/2023
• 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; Other
• Patient Sex: Unknown