MAUDE Adverse Event Report: SMITH & NEPHEW, INC. TRIGEN LOW PROFILE SCREW 5.0MM X 25MM; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Model Number 71645025

Device Problem Defective Device (2588)

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

Event Date 09/19/2020

Event Type  Injury  

Event Description

While attending a short intertan nail for a neck of femur (nof) on a young female with stress fracture to inferior neck, it was found thickened cortices from long history of steroid use for immune disorder.A canal reaming was planned to accommodate 10mm 20cm nail.During the procedure, a short intertan nail was chosen, it was attached to drill guide (drill guide handle) and drop (125 rad drill gde drop) , the nail was introduced over ball tip guide wire.Proximal ics screw guide pin advanced using according drop, it was difficult to advance guide pin to 25mm tip apex (marked resistance).Lag drill (intertan lag screw drill) advanced over guide wire with much difficulty to the required depth (lag screw was tapped to get to the required depth).Black substance noted in flutes of drill.Then the compression drill (7.0mm compression screw drill) met similar resistance but could get the required depth.A distal locking was attempted through the intertan drop, it marked resistance using the drill.A lateral x-ray confirmed screw was not in the nail but posterior to it, screw removed and no further attempt to distal lock was undertaken.A delay of less than 30 min was reported.Procedure concluded using the same devices.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.

Manufacturer Narrative

H3, h6: the device, used in treatment, was not returned for evaluation and the reported event could not be confirmed.The clinical/medical investigation concluded that the provided customer feedback form, chart sticks, and the single photo provided were reviewed.However, without the requested clinical information, operative report, pre/post radiographs, or the device, the root cause of the reported failure cannot be determined.Based on the information provided, the reported x-ray findings and the product evaluation, a procedural vs user error cannot be ruled out as the root cause of the reported event.There is no indication the reported black substance in the flute was in contact with the patient (case- (b)(4).According to the report, due to drop presenting several connections problems through all the instruments that were used in conjunction (case- (b)(4), however, an x-ray confirmed the screw was not in nail but posterior to it.As a result, the screw was removed by the surgeon (case- (b)(4), the procedure completed with the same device with less than a thirty minute delay.The impact to the patient beyond that which has already been reported cannot be determined.Should any additional medical information be provided, this complaint will be re-assessed.Therefore, no further clinical/medical assessment is warranted at this time.A review of complaint history did not reveal additional complaints for the listed batch.A review of the manufacturing records did not reveal any manufacturing or material abnormalities that could have caused or contributed to the reported incident.At this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.A review of the risk management file and instructions for use documents revealed this failure mode and potential harm was previously identified.Possible causes could include but not limited to surgical technique used, size of device or user/procedural variance.Based on this investigation, the need for corrective action is not indicated.Without the return of the actual product involved or product information, our investigation could not proceed.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 25MM
• Type of Device: ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• MDR Report Key: 10689799
• MDR Text Key: 211656826
• Report Number: 1020279-2020-05476
• Device Sequence Number: 1
• Product Code: HSB
• UDI-Device Identifier: 00885556215494
• UDI-Public: 00885556215494
• Combination Product (y/n): N
• PMA/PMN Number: K111025
• 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: 06/30/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/16/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 71645025
• Device Catalogue Number: 71645025
• Device Lot Number: 20BM08516
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/30/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention