MAUDE Adverse Event Report: SMITH & NEPHEW, INC. GII SPC REAMTHRU CR TR SZ 6 RT; PROSTHESIS, KNEE, FEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER

Model Number 71433356

Device Problems Crack (1135); Material Fragmentation (1261)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 09/16/2022

Event Type  malfunction  

Manufacturer Narrative

Internal reference: (b)(4).

Event Description

It was reported that, after cleaning when the set was being re-assembled, it was found that metal separated/cracked from a gii spc reamthru cr tr sz 6 rt.No case involved; therefore, there was no patient involvement.

Manufacturer Narrative

The associated device was returned and evaluated.A visual inspection confirms a fracture and deformation of the fixation rails in the ream through slot of the femoral trial.The fracture and deformation is likely due to the load applied to the trial during the impaction of the trial onto the femur.If the loads applied exceed the strength of the material, a fracture may occur.This device exhibits signs of significant use and wear.A review of complaint history based on the historical data revealed similar events for the listed batch, this failure mode will be monitored for future complaints for any necessary corrective actions.A review of the manufacturing records did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident.At this time, we do not have reason to suspect that the product failed to meet any product specifications at the time of manufacture.A review of the risk management file revealed this failure mode was previously identified.The anticipated risk level is still adequate.Assessment of historical escalated cases concluded that there are no prior actions related to this device and failure mode.As the device broke and it cannot longer fit its purpose, the contribution of the device to the reported event could be corroborated.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 future complaints and investigate as necessary.We consider this investigation closed.

• Brand Name: GII SPC REAMTHRU CR TR SZ 6 RT
• Type of Device: 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 ; 5123913905
• MDR Report Key: 15577859
• MDR Text Key: 301638461
• Report Number: 1020279-2022-04389
• Device Sequence Number: 1
• Product Code: HRY
• UDI-Device Identifier: 00885556032725
• UDI-Public: 00885556032725
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K121393
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 11/02/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/11/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 71433356
• Device Catalogue Number: 71433356
• Device Lot Number: 10FM15474
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/30/2022
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/01/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/24/2010
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: A
• Patient Sequence Number: 1