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

Model Number	72200886
Medical Device Problem Code	Unsealed Device Packaging (1444)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/04/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the ultrabraid white suture package was unsealed.No case reported, no patient was involved.
Additional Manufacturer Narrative
Internal complaint reference: (b)(4).
Additional Manufacturer Narrative
H3, h6: the reported device was not returned to the designated complaint unit for independent evaluation, thus visual inspection and functional testing could not be performed.An evaluation of the customer provided images showed the following: image one shows the carrier cardboard inside of the pouch.Image two shows the tyvek side of the pouch with the identification label.Image three shows the pouch end unsealed with the carrier cardboard inside of the pouch.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 no similar reported events.A review of the packaging procedure found that the pouch seal is required to meet a minimum strength and each shipment must include a certificate of conformance and sterilization.A risk management review found that the reported failure was documented appropriately, and there were no indications to suggest the anticipated risk is not adequate.There was a relationship found between the device and the reported event.The complaint was confirmed but the root cause could not be established as the device was not returned for evaluation.Factor that may have contributed to the reported event include contact with another source.No containment or corrective actions are recommended at this time.If the product associated with this event is returned at a future date, this investigation will be reopened for evaluation.

• 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: 15287870
• Report Number: 1219602-2022-01234
• Device Sequence Number: 14070318
• 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,Health Professional,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 09/28/2022

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?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/04/2022
• Supplement Date Received by Manufacturer: 09/27/2022
• Initial Report FDA Received Date: 08/24/2022
• Supplement Report FDA Received Date: 09/29/2022
• 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