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

Model Number	71440078
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/09/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during a tka, when the surgeon was performing the femoral cuts, using a gii modular femoral slot, he felt some resistance.He continued the cut thinking it was very sclerotic bone, but on removal of the slot, he noticed that there were some metal debris and that parts of the locking posts were broken.He removed the metal debris and continued performing all the cuts.Surgery was performed, after a non-significant delay, with the same device.Patient was not injured beyond the issue reported.
Additional Manufacturer Narrative
Internal complaint reference (b)(4).
Additional Manufacturer Narrative
Corrected data: b1, b2, b5, h1.
Event or Problem Description
It was reported that during a tka, when the surgeon was performing the femoral cuts using a gii modular femoral slot, he felt some resistance.He continued the cut thinking it was very sclerotic bone, but on removal of the slot, he noticed that there were some metal debris and that parts of the locking posts were broken.He removed the metal debris with forceps and continued performing all the cuts.Surgery was performed, after a non-significant delay, with the same device.Patient was not injured beyond the issue reported.
Additional Manufacturer Narrative
H3, h6: the device was not returned for evaluation and the reported event could not be confirmed.The clinical/medical investigation concluded that, per complaint details, the surgeon encountered resistance during the femoral cuts and noted metal debris and broken parts of the locking posts upon removal.Reportedly, the metal debris was removed via forceps and the tka procedure was completed with the same device within a 0-30 minute surgical delay with no patient injury reported.It was communicated that the requested clinical documentation was not available.Based on the limited information provided, definitive contributing clinical factors could not be concluded.The current patient status is unknown.The patient impact beyond that which was reported cannot be determined; however, there was no alleged patient injury due to the reported event.A review of complaint history of the previous 12 months revealed similar events for the listed device, 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 reason to suspect that the product failed to meet any product 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 probable causes of the reported event.We recommend that all reusable instruments be routinely inspected for wear and damage and replaced as necessary.The contribution of the device to the reported event could not be corroborated.Based on this investigation, the need for corrective action is not indicated.Without the return of the actual product involved, our investigation could not proceed.Should the device or 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.Internal complaint reference number: (b)(4).

• Brand Name: GII MODULAR FEMORAL SLOT
• 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 ; 7000 west william cannon drive; austin, TX 78735 ; 5123913905
• MDR Report Key: 15316055
• Report Number: 1020279-2022-03871
• Device Sequence Number: 5517801
• Product Code: HRY
• UDI-Device Identifier: 03596010213884
• UDI-Public: 03596010213884
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K121393
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 11/10/2022

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 Model Number: 71440078
• Device Catalogue Number: 71440078
• Device Lot Number: UNKNOWN
• 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: 08/09/2022
• Supplement Date Received by Manufacturer: 08/09/2022; 11/04/2022
• Initial Report FDA Received Date: 08/29/2022
• Supplement Report FDA Received Date: 11/01/2022; 11/10/2022
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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: Reuse
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown