MAUDE Adverse Event Report: SMITH & NEPHEW, INC. LGN OX CONSTRAIN FEM TRL 3 LT; PROSTH, KNEE, PATE/FEMOROTIBIAL, SEMI-CONST, UNCEM, PORO, COAT, POLY/METAL/POLY

Model Number	71431163
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/16/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that, during a tka procedure, the distal wedge screw broke off while assembling outside of the patient.The procedure was successfully completed without delay using a smith+nephew back-up device.No patient injury or other complications were reported.
Additional Manufacturer Narrative
The device, used in treatment, was returned for evaluation.A visual inspection of the returned device confirmed the stated failure mode.The device has a mating screw lodged into the device.The device was manufactured in 2012 and shows signs of extensive use.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.This device is a reusable instrument that can be exposed to numerous surgeries; damage from repeated use can occur.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.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 complaint will be reopened.No further investigation warranted for this complaint; however we will continue to monitor for future complaints and investigate as necessary.We consider this investigation closed.

• Brand Name: LGN OX CONSTRAIN FEM TRL 3 LT
• Common Device Name: PROSTH, KNEE, PATE/FEMOROTIBIAL, SEMI-CONST, UNCEM, PORO, COAT, POLY/METAL/POLY
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• MDR Report Key: 11646855
• Report Number: 1020279-2021-02859
• Device Sequence Number: 3085028
• Product Code: MBH
• UDI-Device Identifier: 03596010543745
• UDI-Public: 03596010543745
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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
• Type of Report: Initial,Followup
• Report Date (Section B): 04/28/2021

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: 71431163
• Device Catalogue Number: 71431163
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/24/2021
• Initial Date Received by Manufacturer: 03/16/2021
• Supplement Date Received by Manufacturer: 04/08/2021
• Initial Report FDA Received Date: 04/11/2021
• Supplement Report FDA Received Date: 04/28/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1