MAUDE Adverse Event Report: SMITH & NEPHEW, INC. GII UNIVERSAL EXTRACTOR; PROSTHESIS, KNEE, FEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER

Catalog Number	71440366
Medical Device Problem Codes	Fracture (1260); Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/29/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Internal complaint reference: (b)(4).
Event or Problem Description
It was reported that, during a tka surgery, one (1) gii universal extractor broke where it attaches to the box chisel.The procedure was resumed, without any delay, using an equivalent s+n back-up.No further complications were reported.
Additional Manufacturer Narrative
Additional information: the information received by the manufacturer has been re-evaluated for mdr reporting and it was determined that this case does not meet the threshold for reporting and is a non-reportable event since the device broke external to the patient and is of a size and shape which would be easily accounted for.If further details are provided confirming the occurrence of a reportable event, our files will be updated accordingly and a further report submitted outlining both the event details and our investigations performed.While this event is no longer considered reportable, this report is being submitted as a courtesy to provide updated investigation results based on the return and evaluation of the complaint device subsequent to the submission of our previous supplemental report.The associated device was returned and evaluated.The visual inspection revealed the block extractor shaft is fractured off the device.Both the block extractor shaft and the head are heavily damaged, with scratches and gouges as well as severe deformation of the edges.All welds are intact.Device batch number was not provided, thus, an evaluation of the manufacturing records could not be performed.A review of complaint history of the previous 12 months revealed similar events for the listed part number, 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.
Event or Problem Description
It was reported that, during a tka surgery, one (1) gii universal extractor broke where it attaches to the box chisel.The instrument broke outside the patient.The procedure was resumed, without any delay, using an equivalent s+n back-up.No further complications were reported.

• Brand Name: GII UNIVERSAL EXTRACTOR
• Common Device Name: PROSTHESIS, KNEE, FEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER
• 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 ; 1450 brooks rd.; memphis, TN 38116 ; 5123913905
• MDR Report Key: 23617190
• Report Number: 1020279-2025-01918
• Device Sequence Number: 18651386
• Product Code: HRY
• UDI-Device Identifier: 03596010215192
• UDI-Public: 3596010215192
• Combination Product (Y/N): N
• Initial Reporter State: IA
• Initial Reporter Country: US
• PMA/510(K) Number: K121393
• 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
• Report Date (Section B): 12/24/2025

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: 71440366
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/06/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/29/2025
• Supplement Date Received by Manufacturer: 12/18/2025
• Initial Report FDA Received Date: 11/21/2025
• Supplement Report FDA Received Date: 12/24/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: A
• Patient Sequence Number: 1
• Patient Sex: Unknown