MAUDE Adverse Event Report: SURGICAL SPECIALTIES MEXICO QUILL; QUILL 3-0 MONODERM

Model Number	YA1016Q
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/09/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A review of the dhr confirmed the finished good devices and attachments met requirements at time of release.No quality issues were noted throughout the incoming inspection of components, manufacturing, in-process or final inspection processes.No samples were returned for review/testing.The actual device was not available for review.Needles can detach during the process if the suture is not placed deep enough within the needle hole during the manufacturing process, if excessive force is applied during the procedure or if the device(s) are grasped on or near the swaged end of the needle, damaging the suture, allowing the suture to break away from the needle component.Without receiving the actual device for review, receiving sterile devices for needle pull testing/review, photos of the actual suture/needle or receiving detailed information regarding the preoperative preparation of the device, tools utilized to grasp the device, procedure performed or the surgeon's technique, a definitive root cause cannot be determined at this time.
Event or Problem Description
Whole needle detached from suture; broke off in tissue and had to be located by x-ray.The entire needle was retrieved from patient without further incident or injury.Additional surgery time was required (25 min).

• Brand Name: QUILL
• Common Device Name: QUILL 3-0 MONODERM
• Manufacturer (Section D): SURGICAL SPECIALTIES MEXICO; corredor tijuana rosarito 2000; #24702-b ejido francisco villa; tijuana 22235 ; MX 22235
• MDR Report Key: 11216713
• Report Number: 3010692967-2021-00004
• Device Sequence Number: 14348464
• Product Code: GAM
• UDI-Device Identifier: 10848782021793
• UDI-Public: (01)10848782021793(17)250331(10)AAFU226
• Combination Product (Y/N): Y
• Initial Reporter Country: SF
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 01/22/2021
• Report Date (Section F): 01/21/2021

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: 03/03/2025
• Device Model Number: YA1016Q
• Device Catalogue Number: YA1016Q
• Device Lot Number: AAFU226
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 12/09/2020
• Device Age: 9 MO
• Date Report to Manufacturer: 01/21/2021
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/21/2021
• Initial Report FDA Received Date: 01/22/2021
• 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