MAUDE Adverse Event Report: SMITH & NEPHEW, INC. ENDOBUTTON CL ULTRA 15MM; FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE

Model Number 72200146

Device Problem Contamination (1120)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 05/08/2021

Event Type  malfunction  

Manufacturer Narrative

Internal complaint reference case: (b)(4).

Event Description

It was reported that, when opening the "15mm ultrabutton, cl ultra" package, it was found a foreign body inside the package.It is unknown whether the event happened during surgery or if there was a patient involvement.

Manufacturer Narrative

Internal complaint reference: (b)(4).H3,h6 : the reported device, used in treatment, was received for evaluation.There was a relationship found between the returned device and the reported incident.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 customer provided image reveals the white suture loop was not wound as tightly as intended.No debris appears to be on the suture.The image also confirms the batch number and product number.A visual inspection revealed that the suture fibers were not wound together as tightly as specified.There were a few small frays in the fibers.There was no debris.A review of the drawing found that the strand count were specified.The complaint was confirmed and the root cause was associated with component failure.Factors that could have contributed to the event include dislodging or rotation of the mandrel in shipping, excessive stretching of the fibers in removal of the mandrel, or use of sharp objects to open packaging.No containment or corrective actions are recommended at this time.

• Brand Name: ENDOBUTTON CL ULTRA 15MM
• Type of Device: FASTENER, FIXATION, NONDEGRADABLE, SOFT TISSUE
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 130 forbes blvd.; mansfield MA 02048
• MDR Report Key: 11913997
• MDR Text Key: 253762293
• Report Number: 1219602-2021-01272
• Device Sequence Number: 1
• Product Code: MBI
• UDI-Device Identifier: 03596010597250
• UDI-Public: 03596010597250
• Combination Product (y/n): N
• PMA/PMN Number: K980155
• 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: 07/05/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/01/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 72200146
• Device Catalogue Number: 72200146
• Device Lot Number: 2041868
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/07/2021
• Date Manufacturer Received: 07/02/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1