MAUDE Adverse Event Report: SMITH & NEPHEW, INC. T-HANDLE; APPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, MULTIPLE COMPONENT

Catalog Number	71631172
Medical Device Problem Codes	Crack (1135); Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/19/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during internal fixation one (1) t-handle crack.It is unknown how the procedure was completed and if there was a surgical delayed.No patient injuries were reported.
Additional Manufacturer Narrative
Internal complaint number: (b)(4).
Additional Manufacturer Narrative
H10: after further assessment of the information gathered by the manufacturer, it was identified that this event should be re-evaluated for mdr reporting.The original information stated that during internal fixation one (1) t-handle cracked.However, a visual inspection of the returned device reveals one of the connection point of the t-handle is broken off, and it was determined that the issue does not meet the criteria to be reportable, since the t-handle is used external to the patient where it is not possible for pieces to fall into the surgical site/incision.Moreover, if the device malfunction were to recur, it would not be likely to cause or contribute to a death or serious injury.H3, h6: the associated device was returned and evaluated.The visual inspection revealed that the connection point of the t-handle is broken off.This piece was not returned.The device shows signs of extensive wear and use.A device history records review was not performed for this event since based on the device evaluation; no manufacturing, packaging or labelling defects were associated with the reported failure.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 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: APPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, MULTIPLE COMPONENT
• 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: 18511145
• Report Number: 1020279-2024-00104
• Device Sequence Number: 17027653
• Product Code: KTT
• UDI-Device Identifier: 03596010425096
• UDI-Public: 03596010425096
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: K093047
• 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
• Type of Report: Initial,Followup
• Report Date (Section B): 03/06/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 71631172
• Device Lot Number: 470082-2
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/19/2023
• Supplement Date Received by Manufacturer: 03/05/2024
• Initial Report FDA Received Date: 01/15/2024
• Supplement Report FDA Received Date: 03/06/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/01/2009
• 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
• Patient Sex: Unknown