MAUDE Adverse Event Report: SMITH & NEPHEW, INC. GII TIB TRY IMPL IMPACTOR; TRAY, SURGICAL, INSTRUMENT

Catalog Number	71440472
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	03/20/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
H10: internal complaint reference case (b)(4).
Event or Problem Description
It was reported that during a tka revision surgery, the gii tib try impl impactor broke off during tibial implant impaction.The piece fell into the bone and still remains into the patient.It is unknown how the procedure was completed, if there was any delay and if the broken piece will be removed from the patient.No further details provided at the moment.
Additional Manufacturer Narrative
H11: corrected data.B5: describe event or problem.
Event or Problem Description
It was reported that, during a tka surgery, a gii tib try impl impactor broke off during tibial implant impaction.The piece fell into the bone and still remains into the patient.It is unknown how the procedure was completed, if there was any delay or if the broken piece will be removed from the patient.No further details provided at the moment.
Additional Manufacturer Narrative
The associated device was returned and evaluated.The visual inspection revealed that the nut broke off the device causing the tibial lock sub-assembly to separate from the device.The nut was not returned.The device shows signs of extensive wear and use.This inspection was conducted by naked eye.The clinical/medical investigation concluded that one undated x-ray image was provided for review and appears to show a foreign object under the lateral condyle of the tibial baseplate.Currently, no information has been provided on how the procedure was completed, if the reported event caused a delay in the procedure, or any future plans to remove the broken bolt form the patient.All documents and images provided as of this date have been reviewed and considered and unless noted do not contribute to the clinical/medical investigation.Based on the information provided, the clinical root cause of the reported events could not be determined and we are currently unable to rule out a procedural variance as a contributing factor to the reported event, which does not represent a device malfunction.This is an externally communicating device, it is neither manufactured nor intended for implantation.Long-term implantation data is not available.The patient impact includes the broken instrument with subsequent retained non-implantable fragment from the device.Although unlikely, migration, and/or local irritation cannot be ruled out and a transient post-surgical convalescence period would be anticipated.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: GII TIB TRY IMPL IMPACTOR
• Common Device Name: TRAY, SURGICAL, INSTRUMENT
• 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: 19130518
• Report Number: 1020279-2024-00768
• Device Sequence Number: 4658550
• Product Code: FSM
• UDI-Device Identifier: 03596010329875
• UDI-Public: 03596010329875
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• 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: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 08/14/2024

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: 71440472
• Device Lot Number: 08KM17284
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/27/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/21/2024
• Supplement Date Received by Manufacturer: 04/18/2024; 08/13/2024
• Initial Report FDA Received Date: 04/18/2024
• Supplement Report FDA Received Date: 04/22/2024; 08/14/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/23/2008
• 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: Other
• Patient Sex: Unknown