MAUDE Adverse Event Report: SMITH & NEPHEW, INC. ULTRBRD2 COBRAID 38 SNGL ARM PACK AS; SUTURE, NONABSORBABLE, SYNTHETIC, POLYETHYLENE

Model Number 7211081

Device Problem Tear, Rip or Hole in Device Packaging (2385)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 08/19/2020

Event Type  malfunction  

Event Description

It was reported that during an acl procedure, the urgical instrumentalist broke the plastic wrap that covers the secondary packaging and when opening it, found that the primary packaging of the product was open, compromising the sterile condition.The secondary packaging did not have the standard smith-nephew seal, only the plastic wrap.Backup device was available to complete the procedure.No delay and no patient injuries were reported.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.

Manufacturer Narrative

H10, h3, h6: the reported device, used in treatment, was not returned to the designated complaint unit for independent evaluation, thus visual inspection and functional testing could not be performed.A relationship, if any, between the subject device and the reported event could not be determined.Please refer to the instructions for use for recommendations on proper use of the device and potential troubleshooting methods to prevent future occurrence of the reported event.A review of the device history records showed there were no indications to suggest that the product did not meet manufacturing specification or would not be able to perform as intended.A complaint history review concluded this was an isolated event.A review of the product prints found packaging and seal specifications.No containment or corrective actions are recommended at this time.If the product associated with this event is returned at a future date, this evaluation will be reopened for investigation.

• Brand Name: ULTRBRD2 COBRAID 38 SNGL ARM PACK AS
• Type of Device: SUTURE, NONABSORBABLE, SYNTHETIC, POLYETHYLENE
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 130 forbes blvd.; mansfield MA 02048
• MDR Report Key: 10546327
• MDR Text Key: 207310146
• Report Number: 1219602-2020-01415
• Device Sequence Number: 1
• Product Code: GAT
• UDI-Device Identifier: 03596010547682
• UDI-Public: 03596010547682
• Combination Product (y/n): N
• PMA/PMN Number: K041216
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 03/22/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/17/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 7211081
• Device Catalogue Number: 7211081
• Device Lot Number: 74G1903584
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/18/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1