MAUDE Adverse Event Report: SMITH & NEPHEW, INC. T-HANDLE; PROSTHESIS, HIP, FEMORAL COMPONENT, CEMENTED, METAL

Model Number 71364006

Device Problems Break (1069); Material Twisted/Bent (2981)

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

Event Date 06/22/2021

Event Type  Injury  

Manufacturer Narrative

Internal complaint reference case- (b)(4).Initial reporter: postal code (b)(6).

Event Description

It was reported that, during a revision total hip replacement, two (2) t-handles twisted and then broke into sections while the surgeon was reaming the femoral canal by hand.The pieces were retrieved from the patient with forceps.Surgery was resumed, after a non-significant delay.Patient was not harmed as consequence of this problem.

Manufacturer Narrative

H3, h6: the device, used in treatment, was returned for evaluation.A visual inspection confirms the jaws have fractured off the device.The fractured pieces were not returned with the device.The t-handle fractured in the jaws of the handle, likely from static bending or torsional overload.An overload fracture can occur if the mechanical loads applied to the device exceed the strength of the mater.A medical investigation was conducted and confirms this case reports the breakage of two t-handles during manual reaming of the femoral canal.Per case details ¿the pieces were retrieved with forceps, there was no patient harm, and there was ¿a non-significant delay.¿ per product evaluation, ¿a visual inspection confirms the jaws have fractured off the device.The fractured pieces were not returned with the device.No additional clinically relevant information was provided for evaluation.The clinical root cause of the reported breakage cannot be definitively concluded and the impact beyond the reported events cannot be determined at this time, as no patient harm was alleged.Therefore, no further clinical assessment is warranted.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.A review of the risk management file revealed this failure mode was previously identified.This device is a reusable instrument that can be exposed to numerous surgeries; damage from repeated use can occur.Expected wear/tear is likely the probable cause of the reported event.We recommend that all reusable instruments be routinely inspected for wear and damage and replaced as necessary.At this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.Based on this investigation, the need for corrective action is not indicated.Should additional information be received, the complaints will be reopened.No further investigation is warranted for these complaints; however we will continue to monitor for future complaints and investigate as necessary.We consider this investigation closed.

• Brand Name: T-HANDLE
• Type of Device: PROSTHESIS, HIP, FEMORAL COMPONENT, CEMENTED, METAL
• 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: 12697271
• MDR Text Key: 278351520
• Report Number: 1020279-2021-07661
• Device Sequence Number: 1
• Product Code: JDG
• UDI-Device Identifier: 03596010199225
• UDI-Public: 03596010199225
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K123598
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 11/11/2021

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: 71364006
• Device Catalogue Number: 71364006
• Device Lot Number: 18LSY0012
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/06/2021
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 07/12/2021
• Initial Date FDA Received: 10/26/2021
• Supplement Dates Manufacturer Received: 11/10/2021
• Supplement Dates FDA Received: 11/11/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/06/2020
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention