MAUDE Adverse Event Report: SMITH & NEPHEW, INC. GII DCF VARIABLE SZ GUIDE LT; PROSTHESIS, KNEE, FEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER

Model Number	71440007
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Information (3190)
Date of Event	07/16/2020
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that this 3 degree varus valgus adjustment knob is broken.Relevant information that describes the product problem and/or adverse event was not provided.It is unknown whether the incident happened or not in a surgical environment or as consequence of a surgery.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.
Additional Manufacturer Narrative
The device, intended for use in treatment, was returned for evaluation.A visual inspections confirms multiple nicks, scratches, gouges and wear on the device.The device was manufactured in 2013.The device shows sign of significant wear/use.A functional evaluation was conducted with a mating device that confirms the stated failure that the knob is broken and will not lock in place.A review of complaint history on the listed part revealed no prior complaints for the listed batch with the same failure mode.A review of the manufacturing records did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident.This device is a reusable instrument that can be exposed to numerous surgeries; damage from repeated use can occur.Expected wear/tear is likely the probable cause of the reported event.We recommend that all reusable instruments be routinely inspected for wear and damage and replaced as necessary.At this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.Based on this investigation, the need for corrective action is not indicated.Should additional information be received, the complaints will be reopened.No further investigation is warranted for these complaints; however we will continue to monitor for future complaints and investigate as necessary.We consider this investigation closed.

• Brand Name: GII DCF VARIABLE SZ GUIDE LT
• Common Device Name: PROSTHESIS, KNEE, FEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• MDR Report Key: 10393961
• Report Number: 1020279-2020-03839
• Device Sequence Number: 1730113
• Product Code: HRY
• UDI-Device Identifier: 03596010610386
• UDI-Public: 03596010610386
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: K121393
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/20/2020

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 Model Number: 71440007
• Device Catalogue Number: 71440007
• Device Lot Number: 13KM20184
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 07/16/2020
• Supplement Date Received by Manufacturer: 08/14/2020
• Initial Report FDA Received Date: 08/11/2020
• Supplement Report FDA Received Date: 08/20/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1