MAUDE Adverse Event Report: SMITH & NEPHEW, INC. TRIGEN LOW PROFILE SCREW 5.0MM X 35MM; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Model Number 71645035

Device Problems Difficult to Insert (1316); Peeled/Delaminated (1454)

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

Event Date 03/31/2023

Event Type  malfunction  

Event Description

It was reported that, during surgery an internal fixation surgery, while inserting one (1) trigen low profile screw 5.0mm x 35mm into the second distal screw hole of one (1) meta-tan 9mm x 30cm right, it was found that the screw passed the outside but stopped at inside.Repeated attempts to drill again did not resolve the problem.It was confirmed that there was no technique error, and that the screw was not inserted.The procedure was resumed, after 10 minutes surgical delay.No further complications were reported.

Manufacturer Narrative

H3, h6: the associated device was returned and evaluated.The visual inspection revealed some peeling of the protective coating and discoloration.A review made by the quality engineering team revealed that it has been confirmed that the thread's requirements have been met and are conforming, although there is a segment of the thread near the tip that was damaged and believed to have occurred during use.The hex feature on the screw could not have been tested due to the damage that occurred during use.The containment actions can be specifically targeted towards the incident part, considering its isolated impact and the absence of similar events.However, based on the information provided, the unsatisfactory experience could be confirmed.A review of the production order 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 historical review concluded that there are no prior actions related to this product and event.According to the inspection procedure, final inspection includes verifying parts are free of burrs, pits, sharp edges, nicks or damage areas to ensure the correct size of the device.At this time, we have no evidence to suspect that the product failed to meet any specifications at the time of manufacture.Factors that could contribute to the reported event include size selected or user/procedural variance.Based on this investigation, the need for corrective action is not indicated.Should 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.H10: internal complaint reference: (b)(4).

Manufacturer Narrative

The associated device was returned and evaluated.A visual inspection of the returned device reveals some peeling of the protective coating and discoloration.An engineering evaluation reveals after reviewing the details and conducting a thorough assessment, it has been confirmed that the thread's requirements have been met and are conforming, although there is a segment of the thread near the tip that was damaged and believed to have occurred during use.The hex feature on the screw could not have been tested due to the damage that occurred during use.The containment actions can be specifically targeted towards the incident part, considering its isolated impact and the absence of similar events.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 manufacturing records did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident.At this time, we have no evidence to suspect that the product failed to meet any product specifications at the time of manufacture.A review of the risk management file revealed this failure mode was previously identified.The anticipated risk level is still adequate.Assessment of historical escalated cases concluded that there are no prior actions related to this device and failure mode.According to the inspection procedure, final inspection includes verifying parts are free of burrs, pits, sharp edges, nicks or damage areas to ensure the correct size of the device.Factors that could contribute to the reported event include size selected or user/procedural variance.Based on this investigation, the need for corrective action is not indicated.Should additional information be received, the complaint will be reopened.No further investigation is warranted for this complaint; however, we will continue to monitor future complaints and investigate as necessary.We consider this investigation closed.

• Brand Name: TRIGEN LOW PROFILE SCREW 5.0MM X 35MM
• 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: 17283423
• MDR Text Key: 319202237
• Report Number: 1020279-2023-01423
• Device Sequence Number: 1
• Product Code: HSB
• UDI-Device Identifier: 00885556215692
• UDI-Public: 00885556215692
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K092748
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 08/25/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/07/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 71645035
• Device Catalogue Number: 71645035
• Device Lot Number: 22JB00231
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/02/2023
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/22/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/06/2022
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: META-TAN 9MMX30CM RIGHT(PN:71640530,LN:21MT57776)
• Patient Sex: Female