MAUDE Adverse Event Report: SMITH & NEPHEW, INC. KNEE BALANCER SHAFT; PROSTHSIS, KNE, FMOROTIBIAL, SMI-CONSTRIND, CMNTD, MTAL/POLYMR

Model Number	71933037
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/31/2020
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the surgeon complained that measurement markers have become difficult to see.No patient injury, surgery completed with the same item, no closure letter needed, no pictures available.
Additional Manufacturer Narrative
The device, used in treatment, was returned for evaluation.A visual inspections confirms the product marking is fading on the device.There are also multiple scratches, burrs and gouges in the metal.The device exhibits signs of significant use and wear.The device was manufactured in 2014.A complaint history review found related failures; this failure mode will be monitored for future complaints for any necessary corrective actions.A review of the device history records for the listed batch did not reveal any deviation from the standard manufacturing processes.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.

• Brand Name: KNEE BALANCER SHAFT
• Common Device Name: PROSTHSIS, KNE, FMOROTIBIAL, SMI-CONSTRIND, CMNTD, MTAL/POLYMR
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 9720102
• Report Number: 1020279-2020-00596
• Device Sequence Number: 2352795
• Product Code: HRY
• UDI-Device Identifier: 03596010592071
• UDI-Public: 03596010592071
• Combination Product (Y/N): N
• Initial Reporter State: TN
• 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): 04/02/2020

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: 71933037
• Device Catalogue Number: 71933037
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 01/31/2020
• Supplement Date Received by Manufacturer: 03/20/2020
• Initial Report FDA Received Date: 02/18/2020
• Supplement Report FDA Received Date: 04/02/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1