MAUDE Adverse Event Report: SMITH & NEPHEW, INC. TRIGEN LOW PROFILE SCREW 5.0MM X 55MM; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Model Number 71645055

Device Problem Migration or Expulsion of Device (1395)

Patient Problem Failure of Implant (1924)

Event Date 01/04/2022

Event Type  Injury  

Manufacturer Narrative

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

Event Description

It was reported that, after an internal fixation surgery had been performed on (b)(6) 2022, the patient experienced a sensation of backing out from one of the distal screws.This was noticed by x-rays on (b)(6) 2022.It is unknown how this adverse event was solved.Current health status of patient is unknown.

Manufacturer Narrative

H3, h6: the device was not returned for evaluation but the pictures were reviewed, and the implant migration was confirmed.The clinical/medical investigation concluded that, the provided undated x-ray and chart-stiks were reviewed.However, they are limited in view and cannot conclude the root cause of the backing out of the distal screw.It is unknown if and how this adverse event was solved.Without clinically relevant information for evaluation, the root cause of the reported event cannot be definitively concluded.But the inherent instability of fractures at this location could have led to the screw backout.Further patient impact beyond the that which has already been reported cannot be determined.Should any additional relevant clinical information be provided, this complaint would be re-assessed.All documents and images provided as of this date have been reviewed and considered and unless noted do not contribute to the clinical/medical investigation.A review of the manufacturing records did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident.A review of complaint history for the part number over the past 12 months and for the batch number based on historical data of the device did not reveal similar events for the listed device.A review of the instructions for use documents for intramedullary nail system revealed that care should be taken to reduce the risk of loosening of the implanted device has been identified as a postoperative care.A review of the risk management file revealed this failure mode was previously identified.The anticipated risk level is still adequate.A historical review concluded that there are no prior actions related to this product and event.At this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.Some potential probable causes for this event could include a fit/ sizing issue, the inherent instability of fractures or poor insertion technique.The contribution of the device to the reported incident could be corroborated as the screws appear backed out in the x rays.Based on this investigation, the need for corrective action is not indicated.Should the device or additional information be received, the complaint will be reopened.No further investigation is warranted for this complaint; however, we will continue to monitor for future complaints and investigate as necessary.We consider this investigation closed.

• Brand Name: TRIGEN LOW PROFILE SCREW 5.0MM X 55MM
• Type of Device: ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• Manufacturer (Section G): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• Manufacturer Contact: holly topping ; 7000 west william cannon drive; austin, TX 78735 ; 5123913905
• MDR Report Key: 13482812
• MDR Text Key: 285253872
• Report Number: 1020279-2022-00566
• Device Sequence Number: 1
• Product Code: HSB
• UDI-Device Identifier: 00885556216095
• UDI-Public: 00885556216095
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K161264
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 03/13/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/08/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 71645055
• Device Catalogue Number: 71645055
• Device Lot Number: 21DM13158
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/10/2022
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 04/20/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention