MAUDE Adverse Event Report: SMITH & NEPHEW, INC. MNITAC 2.0 TI W/NDL 22-0 ULTRABRAID; STAPLE, FIXATION, BONE

Model Number 72202019

Device Problem Break (1069)

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

Event Date 05/18/2021

Event Type  Injury  

Manufacturer Narrative

Internal complaint reference (b)(4).

Event Description

It was reported that during an ankle surgery, the anchor was broken.A delay less or equal than 30 minutes were reported and the procedure was finished with a smith and nephew back up device in the same bone hole.The pieces were removed from the patient with tweezers.No other complications were reported.

Manufacturer Narrative

Internal complaint reference: (b)(4).Part of the device, used in treatment, was received for evaluation.There was no relationship found between the returned device and the reported incident.An analysis of the customer provided images show the original packaging for the device.A visual inspection of the device found that it was returned in original packaging.The anchor was not returned.The inserter was returned with the needle and suture assembly disassembled.All four needles were present.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 concluded this was an isolated event.The instructions for use was reviewed and found to include conditions of off label use and technique specifics, as well as precautions and warnings related to the use of the device.A review of risk management files found that the reported failure was documented appropriately.The complaint was not confirmed and the root cause could not be determined as the condition in which the device was received did not allow for evaluation of the reported complaint.No containment or corrective actions are recommended at this time.

• Brand Name: MNITAC 2.0 TI W/NDL 22-0 ULTRABRAID
• Type of Device: STAPLE, FIXATION, BONE
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 130 forbes blvd.; mansfield MA 02048
• MDR Report Key: 11968586
• MDR Text Key: 255194946
• Report Number: 1219602-2021-01329
• Device Sequence Number: 1
• Product Code: JDR
• UDI-Device Identifier: 03596010619013
• UDI-Public: 03596010619013
• Combination Product (y/n): N
• PMA/PMN Number: K000797
• 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: 07/15/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/09/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 72202019
• Device Catalogue Number: 72202019
• Device Lot Number: 2038425
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/21/2021
• Date Manufacturer Received: 07/14/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1