MAUDE Adverse Event Report: SURGICAL SPECIALTIES CORPORATION QUILL; 2DE14 3-0 UNDYD MONODERM 30X30

Model Number	YA-1023Q
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Needle Stick/Puncture (2462)
Date of Event	07/25/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Sterile samples from the reported lot, including the actual devices, were not returned for visual review or analysis.Without the actual reported devices, photos of the devices, or detailed information on the method used to remove the device from the packaging, preoperative preparation of the device, or the surgeon¿s technique, a definitive root cause cannot be determined at this time.Contraindications: quill¿ monoderm¿ device is not to be used where extended approximation of tissue under stress is required and is not to be used in conjunction with or for fixation of prosthetic devices (e.G.Heart valves or synthetic grafts) that are non-absorbable in nature.Warnings do not resterilize.Discard opened, unused quill¿ monoderm¿ device and associated surgical needles.Users should be familiar with surgical procedures and techniques involving absorbable sutures before employing quill¿ monoderm¿ device for wound closure, as risk of wound dehiscence may vary with the site of application and the suture material used.Physicians should consider the in vivo performance (under actions section) when selecting a suture for use in patients.The use of this suture may be inappropriate in elderly, malnourished or debilitated patients, or in patients suffering from conditions which may delay wound healing.The safety and effectiveness of the quill¿ monoderm¿ device has not been established for use in fascial closures (including abdominal wall, thoracic and extremity fascial closures), gastrointestinal anastomoses, cardiovascular tissue, neural tissue, ophthalmic surgery, or for use in microsurgery, therefore this product should not be used for these purposes.As this is an absorbable suture material, the use of supplemental nonabsorbable sutures should be considered by the surgeon in the closure of the sites which may undergo expansion, stretching or distention or which may require additional support.As with any foreign body, prolonged contact of any suture with salt solutions, such as those found in the urinary or biliary tracts may result in calculus formation.As an absorbable suture, quill¿ monoderm¿ device may act transiently as a foreign body.Acceptable surgical practice should be followed for the management of contaminated or infected wounds.Precautions: the quill¿ monoderm¿ device contains bidirectionally oriented barbs to anchor tissues and does not require knots to approximate opposing edges of a wound.Tying knots on the barbed section of the material will damage the barbs and potentially reduce the suture tensile strength and barb effectiveness.For the bidirectional forces to be created and for the device to function properly, both sides of the quill¿ monoderm¿ device must be engaged in the tissue.Additionally, when completing placement, an additional backstitch or bite of tissue lateral to the end of the incision is required to lock the device in place.Avoid contacting the quill¿ monoderm¿ device and associated needles with other materials (e.G.Surgical gauze, drapes, etc.) in the surgical field to prevent ensnaring on the barbs.If the barbs catch, carefully pull the material in the opposite direction of the needle to disengage it from the barbs.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.Do not pull the quill¿ monoderm¿ device out of the package by the needles as this can cause the barbs to catch on one another.Do not attempt to remove memory in the polymer by running fingers down the suture material as this can damage the barbs.Infections, erythema, foreign body reactions, transient inflammatory reactions and in rare instances dehiscence are typical or foreseeable risks associated with any suture and hence are also potential complications associated with the quill¿ monoderm¿ device.When using the quill¿ monoderm¿ device subcutaneously, the device should be placed as deeply as possible in order to minimize erythema and induration usually associated with absorption.Acceptable surgical practice should be followed with respect to drainage and closure of infected wounds.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.Reshaping needles may cause them to lose strength and be less resistant to bending and breaking.Users should exercise caution when handling surgical needles to avoid inadvertent needle sticks.Discard used needles in ¿sharps¿ containers.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 condition which may delay wound healing, infection, minimal acute inflammatory tissue reaction, localized irritation which skin sutures are left in place for greater than 7 days, suture extrusion and delayed absorption in tissue with poor blood supply, calculi formation in urinary and biliary tracts when prolonged contact with salt solutions such as urine and bile occurs and transitory local infection at 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.
Event or Problem Description
It was reported on (b)(6)2024 that a needle detached from a suture intraoperatively.Intervention was required as a result of the needle puncturing the patient's gums.

• Brand Name: QUILL
• Common Device Name: 2DE14 3-0 UNDYD MONODERM 30X30
• Manufacturer (Section D): SURGICAL SPECIALTIES CORPORATION; corredor tijuana rosarito 2000; #24702 b, ejido franciso villa; tijuana baja california 22235 ; MX 22235
• Manufacturer (Section G): SURGICAL SPECIALTIES CORPORATION; 247 station drive; westwood
• Manufacturer Contact: joseph scoma ; corredor tijuana-rosarito 2000 #24702b; ejido francisco villa; tijuana
• MDR Report Key: 20457220
• Report Number: 3010692967-2024-00089
• Device Sequence Number: 20774733
• Product Code: GAM
• UDI-Device Identifier: 00848782021932
• UDI-Public: 00848782021932
• Combination Product (Y/N): N
• PMA/510(K) Number: K141558
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 10/15/2024

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 Expiration Date: 08/28/2026
• Device Model Number: YA-1023Q
• Device Lot Number: B826FNP
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/26/2024
• Initial Report FDA Received Date: 10/15/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/29/2021
• 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): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention; Other
• Patient Sex: Unknown