MAUDE Adverse Event Report: SMITH & NEPHEW, INC. TRIGEN LOW PROFILE SCREW 5.0MM X 30MM; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Model Number 71645030

Device Problem Material Twisted/Bent (2981)

Patient Problems Bone Fracture(s) (1870); Failure of Implant (1924); Insufficient Information (4580)

Event Date 06/18/2022

Event Type  Injury  

Manufacturer Narrative

Internal complaint reference: (b)(4).

Event Description

It was reported that, after an internal fixation was performed on (b)(6) 2022, the patient experienced early compression, causing the lag/comp screw kit 90/85 to begin pulling from the head of the femur.This event was treated by a revision surgery on (b)(6) 2022, in which the intertan 10s 10mm x 18cm 130d was removed.During the removal, the trigen low profile screw 5.0mm x 30mm stripped out.Several techniques were used for the removal, including driving the screw to the far cortex, fracturing the femur.Current health status of patient is unknown.

Manufacturer Narrative

H3, h6: the device was not returned for evaluation but the reported event could be confirmed since the provided photos did reveal the screw is stripped out.The clinical/medical investigation concluded that, per the complaint details, we are currently unable to rule out a procedural variance as a contributing factor to the reported event which does not represent a device malfunction.No relevant supporting documentation was provided for inclusion in the medical investigation.Based on the information provided in the complaint, this adverse event was treated with a revision surgery two days later in which the intertan 10s 10mm x 18cm 130d was removed.The four undated, unlabeled images attached supports the complaint.The impact to the patient beyond that which has already been reported cannot be confirmed nor concluded.Therefore, no further clinical/medical assessment is warranted at this time.Should any additional relevant medical information be provided, this cause would be re-assessed.A review of complaint history for the previous 12 months did not reveal similar events for the listed device.A review of the instructions for use documents for intramedullary nail system revealed that the general principles of patient selection and sound surgical judgment apply to the intramedullary nailing procedure.Correct surgical technique is essential to a successful outcome.Proper reduction of fractures and proper placement of implants are necessary to effectively treat patients using metallic surgical implants.The surgical technique should be reviewed for effective surgical procedures have been identified as preoperative planning/surgical technique.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.Potential causes could include but are not limited to friction, surgical technique used or user/procedural variance.The contribution of the device to the reported event could be corroborated since the photos revealed the screw is stripped out and several techniques were used for the removal, including driving the screw to the far cortex, fracturing the femur.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 30MM
• 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: 14974298
• MDR Text Key: 295601279
• Report Number: 1020279-2022-03276
• Device Sequence Number: 1
• Product Code: HSB
• UDI-Device Identifier: 00885556215593
• UDI-Public: 00885556215593
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K111025
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 08/16/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 71645030
• Device Catalogue Number: 71645030
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 06/18/2022
• Initial Date FDA Received: 07/11/2022
• Supplement Dates Manufacturer Received: 08/12/2022
• Supplement Dates FDA Received: 08/16/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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
• Treatment: INTERTAN 10S 10MM X 18CM 130D, LOT#21JM06374
• Patient Outcome(s): Required Intervention; Hospitalization