MAUDE Adverse Event Report: SMITH & NEPHEW, INC. META TAN SCREW; NAIL, FIXATION, BONE

Catalog Number 71649742

Device Problem Fracture (1260)

Patient Problem Injury (2348)

Event Date 02/05/2020

Event Type  Injury  

Event Description

It was reported that a meta-tan compression/lag screw was used to fix a fracture, but it failed.The event was treated via revision to change it to a peri-loc distal femoral plate.

Manufacturer Narrative

It was reported that a meta-tan compression/lag screw was used to fix a fracture, but it failed.The event was treated via revision to change it to a peri-loc distal femoral plate.The affected nail along with screws, used in treatment, were returned and evaluated.A visual inspection of the returned devices could not confirm the stated failure mode.The devices are heavily damaged from use.A review of the complaint history for the listed parts revealed no prior complaints for the listed failure mode with the same batch number.A review of the manufacturing records for the listed batches did not reveal any deviation from the standard manufacturing processes.At this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.A relationship, if any, between the devices and the reported incident could not be corroborated.A review of risk management files and the instructions for use found that the reported failure was documented appropriately.A clinical evaluation noted that no relevant supporting documentation was provided, therefore a thorough medical investigation could not be performed.Based on this investigation, the need for corrective action is not indicated.Potential causes could include but not limited to patient conditions, post-operative healing issue or surgical technique used.No further investigation is warranted for this complaint; however we will continue to monitor for future complaints and investigate as necessary.Should additional information be received, the complaint will be reopened.

• Brand Name: META TAN SCREW
• Type of Device: NAIL, FIXATION, BONE
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 9718888
• MDR Text Key: 179771355
• Report Number: 1020279-2020-00586
• Device Sequence Number: 1
• Product Code: JDS
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Type of Report: Initial,Followup
• Report Date: 09/25/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/18/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 71649742
• Device Lot Number: 16AT63902
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/15/2020
• Date Manufacturer Received: 09/21/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention