MAUDE Adverse Event Report: SMITH & NEPHEW, INC. SUTURE, #2 WHITE, ULTRABRAID, 38"; SUTURE, NONABSORBABLE, SYNTHETIC, POLYETHYLENE

Model Number	72200886
Medical Device Problem Code	Tear, Rip or Hole in Device Packaging (2385)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/17/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during set up, a suture #2 ultrabraid had holes in the product´s package, observed by the nurse before usage.There was a back-up device available and non-significant delay was reported.There was no patient involvement.
Additional Manufacturer Narrative
Internal complaint reference: (b)(4).
Additional Manufacturer Narrative
Internal complaint reference (b)(4).H3, h6: the reported device was received for evaluation.A visual evaluation of the device showed that it was not returned in the original outer packaging.The individual pouch has the batch number of the complaint on the label.The vendor seal is complete and sealed.The open/non-chevron end had, at some point, been folded over and stapled but then the staple was removed leaving only the holes and a fold line.There is no indication that the pouch has been sealed.There is no "frost" from the tyvek and nylon or mylar being sealed together at any point across the open/non-chevron end.A review of device records showed there were no indications to suggest that the product did not meet manufacturing specification upon release for distribution.A complaint history review found similar reported events.A risk management review found that the reported failure and/or harm was documented appropriately, and there were no indications to suggest the anticipated risk is not adequate.A review of the package assembly, found the pouch seal strength to be a minimum of 1 lbs/inch minimum.The root cause was associated to manufacturing.The complaint was escalated to the manufacturing team and after review has determined no containment or corrective actions are recommended at this time.Internal complaint reference (b)(4).

• Brand Name: SUTURE, #2 WHITE, ULTRABRAID, 38"
• Common Device Name: SUTURE, NONABSORBABLE, SYNTHETIC, POLYETHYLENE
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 130 forbes blvd.; mansfield MA 02048
• Manufacturer (Section G): SMITH & NEPHEW, INC.; 130 forbes blvd.; mansfield MA 02048
• Manufacturer Contact: holly topping ; 7000 west william cannon drive; austin, TX 78735 ; 5123913905
• MDR Report Key: 15397328
• Report Number: 1219602-2022-01339
• Device Sequence Number: 12311655
• Product Code: GAT
• UDI-Device Identifier: 03596010587657
• UDI-Public: 03596010587657
• Combination Product (Y/N): N
• Initial Reporter Country: HK
• PMA/510(K) Number: K041216
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Consumer,Health Professional,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/01/2024

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 Expiration Date: 07/31/2023
• Device Model Number: 72200886
• Device Catalogue Number: 72200886
• Device Lot Number: 74G1801417
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/18/2022
• Supplement Date Received by Manufacturer: 02/29/2024
• Initial Report FDA Received Date: 09/09/2022
• Supplement Report FDA Received Date: 03/01/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/11/2018
• 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