MAUDE Adverse Event Report: SURGICAL SPECIALTIES CORPORATION QUILL; 2-0 UNI PDO 15CM

Model Number	2-0 UNI PDO 15CM
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/21/2025
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.Review of labeling: indications quill¿ device comprised of dyed pdo is indicated for use in soft tissue approximation where use of absorbable sutures is appropriate.Contraindications the quill¿ device comprised of dyed pdo is not to be used where prolonged (beyond six weeks) approximation of tissues under stress is required and is not to be used in conjunction or for fixation of prosthetic devices (e.G.Heart valves or synthetic grafts) that are non-absorbable in nature.Precautions the quill¿ device contains a loop end and barbs to anchor tissues and does not require knots to approximate opposing edges of a wound.Tying of knots on the barbed section of the material will damage the barbs and potentially reduce their effectiveness.For the device to function properly, quill¿ device must first be anchored in the tissue by the deployment of the loop around robust tissue, then with the other subsequently engaged in the tissue by the barbs.Additionally, when completing placement of the barbed segment, an additional backstitch or bite of tissue lateral to the end of the incision is required to lock the quill¿ device in place.Avoid contacting the quill¿ device 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 straight needle to disengage it from the barbs.When using the quill¿ device subcutaneously, the device should be placed as deeply as possible in order to minimize erythema and induration normally associated with absorption.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 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 wound dehiscence are typical or foreseeable risks associated with any suture and hence are also potential complications associated with quill¿ device.Acceptable surgical practice should be followed with respect to drainage and closure of infected wounds.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 designated biohazard ¿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 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, calculi formation in urinary and biliary tracts when prolonged contact with salt solutions 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.Due to prolonged suture absorption, some irritation and bleeding may occur.
Event or Problem Description
It was reported on (b)(6) 2025 that a needle detached from a suture intraoperatively.No patient injury occurred; however, there was a procedural delay, and intervention was required to retrieve the needle from the patient.No additional procedure was required.
Additional Manufacturer Narrative
Samples passed the minimum acceptable results through the pull testing, and no signs of needle detachment were observed.Detailed information on the method used to remove the device from the packaging, preoperative preparation of the device, or the surgeon¿s technique was not shared; therefore, a definitive root cause cannot be determined at this time.

• Brand Name: QUILL
• Common Device Name: 2-0 UNI PDO 15CM
• Manufacturer (Section D): SURGICAL SPECIALTIES CORPORATION; corredor tijuana rosarito 2000; #24702 b; tijuana baja california 22235 ; MX 22235
• Manufacturer (Section G): SURGICAL SPECIALTIES CORPORATION; corredor tijuana-rosarito 2000; no. 24702-b; tijuana, b.c. 22235 ; MX 22235
• Manufacturer Contact: vida keene ; 247 station drive; westwood, MA 02090
• MDR Report Key: 22006203
• Report Number: 3010692967-2025-00032
• Device Sequence Number: 7109120
• Product Code: NEW
• UDI-Device Identifier: 00848782023660
• UDI-Public: 00848782023660
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K132268
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• 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,Followup
• Report Date (Section B): 05/12/2025

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?: No
• Operator of Device: Health Professional
• Device Model Number: 2-0 UNI PDO 15CM
• Device Lot Number: F110QFB
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/12/2025
• Supplement Report FDA Received Date: 06/11/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/18/2025
• 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: Other; Required Intervention
• Patient Sex: Unknown