MAUDE Adverse Event Report: SMITH & NEPHEW, INC. GII MI IN SLT 3 MO TI CU BL LT; PROSTHSISKNEPATELLOFMORTIBIALSMICONSTRAINDUNCMNTDPOROUSCOATDPOLYMRMTALPOLYMER

Model Number	71441136
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Injury (2348)
Date of Event	01/22/2020
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that when using the drill guide, the screw was stuck, so when the alignment guide was removed it pulled upward the pins in the tibia.After removing the alignment guide from the drill guide, it was noticed that the pins had move upwards in their holes, so they were loose.The tibia cut couldn't be done properly so it was needed to be drilled to achieve the cut.Delay of 10 minutes.
Additional Manufacturer Narrative
The device, used in treatment, was not returned for evaluation and the reported event could not be confirmed.The medical investigation concluded that clinically relevant supporting documentation was not provided; therefore, a thorough medical investigation could not be performed.Without the product evaluation, the root cause of the reported event could not be definitively concluded.It was communicated that no patient injury resulted from the approximate 10 minute surgical extension.Patient impact beyond the reported intraoperative event and minor surgical extension is not anticipated.No further medical assessment is warranted at this time.A review of complaint history did not reveal additional complaints for the listed batch.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 have no 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.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.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.
Additional Manufacturer Narrative
The associated device, used in treatment, was returned and evaluated.A visual inspection of the returned device could not confirm the stated failure mode.The device has scratches, nicks and burrs on the surface and in the cutting slots and fixation holes.The device was manufactured in 2017 and shows signs of significant wear/ usage.The medical investigation concluded that this complaint was reopened due to receipt of device for a product evaluation.No additional medically relevant documentation/ information was provided; therefore, no further medical assessment could be rendered at this time.The functional evaluation confirmed the stated failure mode.The thumbscrew on the device is seized and will not retain a mating part as intended.A review of complaint history did not reveal additional complaints for the listed batch.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.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.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 MI IN SLT 3 MO TI CU BL LT
• Common Device Name: PROSTHSISKNEPATELLOFMORTIBIALSMICONSTRAINDUNCMNTDPOROUSCOATDPOLYMRMTALPOLYMER
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 9671506
• Report Number: 1020279-2020-00484
• Device Sequence Number: 353987
• Product Code: MBH
• UDI-Device Identifier: 03596010484086
• UDI-Public: 03596010484086
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K121393
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,u
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/18/2020

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: 71441136
• Device Catalogue Number: 71441136
• Device Lot Number: 17CM22980
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/22/2020
• Initial Date Received by Manufacturer: 01/23/2020
• Supplement Date Received by Manufacturer: 04/15/2020; 06/15/2020
• Initial Report FDA Received Date: 02/05/2020
• Supplement Report FDA Received Date: 04/16/2020; 06/18/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention