MAUDE Adverse Event Report: ALCON RESEARCH, LLC - ALCON PRECISION DEVICE ALCON CLOSURE SYSTEM (ACS), NYLON; SUTURE, NONABSORBABLE, SYNTHETIC, POLYAMIDE

Catalog Number	8065692101
Medical Device Problem Code	Dull, Blunt (2407)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Investigation including root cause analysis is in progress.A supplemental mdr will be filed as necessary in accordance with 21 cfr 803.56 when additional reportable information becomes available.The manufacturer internal reference number is: (b)(4).
Event or Problem Description
A physician reported that during surgery, blade of suture was dull.Surgery was completed without product replacement and with no patient harm.
Additional Manufacturer Narrative
Corrected information is provide in section d.4.Additional information is provide in sections h.6 and h.11.A sample was not received at the manufacturing site for evaluation for the report of blade for suture was dull; therefore, the condition of the product could not be verified.A review of the device history record traceable to the reported lot number indicates that the reported product was processed and released according to the reported product¿s acceptance criteria.Because a sample was not received and the device history record review of the lot number provided indicated the product was processed and released according to the product¿s acceptable criteria, the root cause for customer complaint issue cannot be determined.The exact root cause for the suture needle dull is unknown, therefore specific action with regards to this complaint cannot be taken.All suture needles are 100% inspected by trained operators using a minimum of 10x magnification during manufacturing.Complaints are reviewed and monitored at regular intervals for any significant adverse trends.No adverse trends have been observed associated with the reported product and event.No additional action is required at this time.The manufacturer internal reference number is: (b)(4).

• Brand Name: ALCON CLOSURE SYSTEM (ACS), NYLON
• Common Device Name: SUTURE, NONABSORBABLE, SYNTHETIC, POLYAMIDE
• Manufacturer (Section D): ALCON RESEARCH, LLC - ALCON PRECISION DEVICE; 714 columbia avenue; sinking spring PA 19608
• Manufacturer (Section G): ALCON RESEARCH, LLC - ALCON PRECISION DEVICE; 714 columbia avenue; sinking spring PA 19608
• Manufacturer Contact: jonathan schlech ; 6201 south freeway; mail stop ab2-6; fort worth, TX 76134 ; 8007579780
• MDR Report Key: 20123573
• Report Number: 2523835-2024-02023
• Device Sequence Number: 7483020
• Product Code: GAR
• UDI-Device Identifier: 00380656921011
• UDI-Public: (01)00380656921011(17)280831(11)230919(10)167070(21)NA
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K930517
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• 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 Catalogue Number: 8065692101
• Device Lot Number: 167070
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/05/2024
• Supplement Date Received by Manufacturer: 11/05/2024
• Initial Report FDA Received Date: 09/03/2024
• Supplement Report FDA Received Date: 12/03/2024
• Date Device Manufactured: 09/19/2023
• 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