MAUDE Adverse Event Report: SURGICAL SPECIALTIES CORPORATION QUILL; QUILL PDO 3-0 VIOLET 24CM X 24CM PS BI

Model Number	RA-1052Q-0
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Post Operative Wound Infection (2446)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A review of the device history record was conducted, and no nonconformances, deviations, or anomalies were identified that could explain the reported failure.The lot in question was inspected and accepted for use in accordance with proper manufacturing processes and procedures.The devices were not returned for analysis, and no photos or supporting documentation were provided for review.Due to the lack of information on pre- and post-operative events, product handling and storage, as well as the absence of images or details regarding surgical technique, a definitive root cause cannot be determined at this time.Review of labeling: precautions: infections, erythema, foreign body reactions, transient inflammatory reactions and in rare instances, wound dehiscence, are typical and foreseeable risks associated with any suture and hence are also potential complications associated with quill.Adverse reactions: adverse effects associated with the use of this device may include wound dehiscence, failure to provide adequate wound support in closure of the site where expansion, stretching or distension occur, failure to provide adequate wound support in elderly, malnourished, or debilitated patients or in patients suffering from conditions which may delay wound healing, infection, minimal acute inflammatory tissue reaction, localized irritation when skin sutures are left in place for greater than 7 days, suture extrusion and delayed absorption in tissue with poor blood supply, calculiformation in urinary and biliary tracts when prolonged contact with salt solutions such as urine and bile occurs and transitory local infection as the wound site.Broken needles may result in extended or additional surgeries or residual foreign bodies.Inadvertent needle sticks with contaminated surgical needles may result in the transmission of bloodborne pathogens.Due to prolonged suture absorption, some irritation and bleeding may occur.
Event or Problem Description
On 2024-09-09, a report was received regarding adverse effects observed after the use of quill sutures during breast surgeries at the university hospital.Two patients experienced complications a few days post-procedure, including thread breakage at the suture site and severe wound infections.The surgeon had to remove the broken suture fragments, re-suture the wounds, and administer treatment for wound suppuration.This serves as two of two reports.

• Brand Name: QUILL
• Common Device Name: QUILL PDO 3-0 VIOLET 24CM X 24CM PS BI
• 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: audrey mudderman ; corredor tijuana-rosarito 2000 #24702b; ejido francisco villa; tijuana
• MDR Report Key: 20304173
• Report Number: 3010692967-2024-00078
• Device Sequence Number: 7745071
• Product Code: NEW
• UDI-Device Identifier: 00848782019038
• UDI-Public: 00848782019038
• Combination Product (Y/N): N
• PMA/510(K) Number: K080985
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial

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?: No
• Operator of Device: Health Professional
• Device Model Number: RA-1052Q-0
• Device Catalogue Number: RA-1052Q-0
• Device Lot Number: C221OBS
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/09/2024
• Initial Report FDA Received Date: 09/25/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 02/21/2022
• 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