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

Catalog Number	71364006
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Codes	Laceration(s) (1946); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/15/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Internal complaint reference:(b)(4).
Event or Problem Description
It was reported that during a thr surgery, the t- handle 71364006 on the redapt hip kit broke under tension in trying to ream the femur, very difficult bone, to ream due to patient condition.The reamer had jammed into the femur and handle broke due to it trying to retrieve the jammed reamer, surgeon had to use slap hammer to get the reamer out.No pieces of the hand piece entered the patient.The procedure was resumed, after a non-significant delay, but it is unknown how.Patient was not harmed as consequence of this problem.
Event or Problem Description
It was reported that during a thr surgery, the t- handle 71364006 on the redapt hip kit broke under tension in trying to ream the femur, very difficult bone, to ream due to patient condition.The reamer had jammed into the femur and handle broke due to it trying to retrieve the jammed reamer, surgeon had to use slap hammer to get the reamer out.Also, the surgeon performed an extended trochanteric osteotomy (eto) to remove the reamer.No pieces of the hand piece entered the patient.The procedure was resumed, after a non-significant delay, but it is unknown how.Patient was not harmed as consequence of this problem.
Additional Manufacturer Narrative
Corrected data: b5, h6 (health effect - clinical code & health effect - impact code).
Event or Problem Description
It was reported that during a thr surgery, the t- handle 71364006 on the redapt hip kit broke under tension in trying to ream the femur, very difficult bone, to ream due to patient condition.The reamer had jammed into the femur and handle broke due to it trying to retrieve the jammed reamer, surgeon had to use slap hammer to get the reamer out.Also, the surgeon performed an extended trochanteric osteotomy (eto) to remove the reamer.No pieces of the hand piece entered the patient.The procedure was resumed, after a non-significant delay.
Additional Manufacturer Narrative
Additional information: h6 (component code, type of investigation, investigation findings, investigation conclusions).Results of investigation: the device was received for evaluation at the manufacturing site, but a physical product evaluation was not possible.However, the photographs were reviewed, and revealed that the device is fractured.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 revealed similar events for the listed device over the previous 12 months, but no similar events for the batch based on the historical data, this failure mode will be monitored for future complaints for any necessary corrective actions.A review of instructions for use for care, maintenance, cleaning and sterilization of smith & nephew orthopedics devices revealed that visually inspecting for damage or wear, including components in their disassembled state prior to re-assembly as well as ensuring components are re-assembled securely is indicated.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 evidence to conclude that the product failed to meet any specifications at the time of manufacture.This device is a reusable instrument that can be exposed to numerous surgeries.Damage from prolonged use, misuse or rough handling are likely potential factors that could contribute to the reported event.We recommend that all reusable instruments be routinely inspected for wear and damage and replaced as necessary.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.

• Brand Name: T-HANDLE
• Common Device Name: 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: 19261084
• Report Number: 1020279-2024-00897
• Device Sequence Number: 6493260
• Product Code: JDG
• UDI-Device Identifier: 03596010199225
• UDI-Public: 3596010199225
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K123598
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 08/16/2024

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
• Operator of Device: Health Professional
• Device Catalogue Number: 71364006
• Device Lot Number: 22BSY0018
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/15/2024
• Supplement Date Received by Manufacturer: 05/08/2024; 08/07/2024; 08/12/2024
• Initial Report FDA Received Date: 05/07/2024
• Supplement Report FDA Received Date: 05/09/2024; 08/08/2024; 08/18/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/10/2022
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown