MAUDE Adverse Event Report: SURGICAL SPECIALTIES CORPORATION SHARPOINT PLUS; PLAIN GUT 6-0 1X18" G-1

Model Number	B774N
Medical Device Problem Code	Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	Foreign Body Sensation in Eye (1869)
Date of Event	10/21/2024
Type of Reportable Event	Malfunction
Event or Problem Description
On 7 nov 2024, it was reported that a patient who had undergone eyelid surgery on (b)(6) 2024, experienced issues with the suture, which did not absorb as anticipated.
Additional Manufacturer Narrative
The patient reported the following regarding their eyelid surgery recovery: the right eye healed with mild discomfort, while the left eye experienced persistent discomfort, especially around the outer corner.On (b)(6), a suture tail appeared in the center of the lower left eyelid, which the patient removed.On (b)(6), the patient removed another loose suture from the lower left eyelid, which relieved the irritation.Based on our review of the device history record (dhr) for the subject device, there were no recorded nonconformances, deviations, or other manufacturing anomalies that could account for the reported failure.All production and inspection processes were completed in accordance with specified requirements, and no irregularities were identified that would have impacted the device's functionality or quality.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 03-6077r1: 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.Adverse reactions: averse effects associated with the use of this device may include: would dehiscence; variable rates or absorption over time; 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 patents 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.

• Brand Name: SHARPOINT PLUS
• Common Device Name: PLAIN GUT 6-0 1X18" G-1
• 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; tijuana
• MDR Report Key: 20835781
• Report Number: 3010692967-2024-00098
• Device Sequence Number: 19812940
• Product Code: GAM
• UDI-Device Identifier: 00848782012169
• UDI-Public: 00848782012169
• Combination Product (Y/N): N
• PMA/510(K) Number: K014021
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 12/03/2024

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 Model Number: B774N
• Device Catalogue Number: B774N
• Device Lot Number: E614VVW
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/07/2024
• Initial Report FDA Received Date: 12/03/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/15/2024
• 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
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 75 YR
• Patient Sex: Male
• Patient Weight: 73 KG