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

Catalog Number 71645030

Device Problem Device Damaged by Another Device (2915)

Patient Problems Failure of Implant (1924); No Known Impact Or Consequence To Patient (2692)

Event Date 06/01/2020

Event Type  Injury  

Event Description

It was reported that during surgery when instruments where inside the patient, the mating part on t-handle broke while inserting screw using the medium hexdriver.Then the t-handle was changed to a t-handle universal chuck.The screw was inserted, but the threaded end on the inner rod of medium hexdriver broke.The piece remained inside the screw thread.Therefore, the trigen low profile screw 5.0mm x 30mm was removed using a power tool from the hospital.A different size screw (5.0mm×32.5mm) was opened and inserted somehow using the broken t-handle and the long hexdriver.There was a 20 min delay.

Manufacturer Narrative

The associated device, used in treatment, was returned and evaluated.A visual inspection of the returned device confirmed the stated failure mode.The head of the device is stripped from attempted insertion by a drill bit, rendering the device inoperative.The damage could have been caused by use of the power tool.The clinical/medical evaluation concluded that per report all of the broken pieces were recovered.Photos were provided via e-mail which confirm the reported events.Although a twenty minute delay was noted, no patient injuries or adverse consequences were reported.Since no patient injuries are being reported 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 a manufacturing abnormality that could have caused or contributed to the reported incident.At this time, we do not have 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.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.Additional information: d4, d8/d9 and g1.

• 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
• MDR Report Key: 10191786
• MDR Text Key: 196314370
• Report Number: 1020279-2020-02702
• Device Sequence Number: 1
• Product Code: HSB
• 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: 10/19/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/24/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 71645030
• Device Lot Number: 20BM18088
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/01/2020
• Date Manufacturer Received: 10/18/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention