MAUDE Adverse Event Report: SURGICAL SPECIALTIES CORPORATION SHARPOINT PLUS; B1828N

Model Number	B1828N
Medical Device Problem Code	Separation Problem (4043)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/09/2025
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: contraindications this suture, being absorbable, should not be used where extended approximation of tissue is required.The use of this suture is contraindicated in patients with known sensitivities or allergies to collagen or chromium, as gut is a collagen based material, and chromic gut is treated with chromic salt solutions.Warnings: do not resterilize.Discard open, unused sutures and associated surgical needles.Users should be familiar with surgical procedures and techniques involving polypropylene suture before employing polypropylene suture for wound closure, as the 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.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.Acceptable surgical practice must be followed with respect to drainage and closure of infected or contaminated wounds.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.Certain patients may be hypersenstitive to collagen or chromium and might exhibit an immunological reaction resulting in inflammation, tissue granulation or fribrosis, wound suppuration and bleeding, as well as sinus formation.Precautions: 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 gut suture.The surgeon should avoid unnecessary tension when running down knots, to reduce the occurrence of surface fraying and weakening of the strand.Under some circumstances, notably orthopedic procedures, immobilization of joints by external support may be employed at the discretion of the surgeon.Avoid prolonged exposure to elevated temperature.Consideration should be taken in the use of absorbable sutures in tissue with poor blood supply as suture extrusion and delayed absorption may occur.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; variable rates of absorption over time (depending on the type of suture used; the presence of infection and tissue sites); failure to provide adequate wound support in closure of sites where expansion, stretching or distension occur, etc., unless additional support is supplied through the use of nonabsorbable suture material; failure to provide adequate wound support in elderly, malnourished, or debilitated patients or in patients suffering from conditions which may delay wound healing; allergic response in patients with known sensitivities to collagen or chromium which may result in an immunological reaction resulting in inflammation, tissue granulation or fibrosis, wound suppuration and bleeding as well as sinus formation; infection; moderate tissue inflammatory response characteristic of foreign body response; calculi formation in urinary and biliary tracts when prolonged contact with salt solutions such as urine and bile occurs; and transitory local irritation at the wound site.
Event or Problem Description
It was reported on (b)(6) 2025 that a needle detached from a suture intraoperatively.No patient injury occurred; however, intervention was required to retrieve the needle from the patient.
Additional Manufacturer Narrative
Product was returned for investigation and the complaint could not be confirmed.The reported condition cannot be confirmed since samples passed the minimum acceptable results through the pull testing, and no signs of needle detachment were observed.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.The product was found to be manufactured/inspected according to criteria/procedure.

• Brand Name: SHARPOINT PLUS
• Common Device Name: B1828N
• Manufacturer (Section D): SURGICAL SPECIALTIES CORPORATION; corredor tijuana rosarito 2000; #24702 b; tijuana baja california 22235 ; MX 22235
• Manufacturer (Section G): CORZA MEDICAL; 247 station drive; westwood MA 02090
• Manufacturer Contact: vida keene ; 247 station drive; westwood, MA 02090
• MDR Report Key: 22331020
• Report Number: 3010692967-2025-00040
• Device Sequence Number: 8410603
• Product Code: GAL
• UDI-Device Identifier: 00848782030613
• UDI-Public: 00848782030613
• Combination Product (Y/N): N
• Initial Reporter State: CT
• Initial Reporter Country: US
• PMA/510(K) Number: K896554
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/25/2025

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: B1828N
• Device Lot Number: E229VNR
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/09/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 06/25/2025
• Supplement Report FDA Received Date: 07/30/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/02/2024
• 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
• Patient Sex: Unknown