MAUDE Adverse Event Report: SMITH & NEPHEW, INC. LGN AP FEM CUTTING BLK SZ 7; PROSTHESIS, KNEE, FEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER

Catalog Number	71434412
Medical Device Problem Codes	Break (1069); Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/19/2018
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during procedure the cutting block broke as surgeon was cutting the femur.All pieces accounted for.Delay of less than 30min reported.No injury reported.No confirmation if procedure was completed.
Additional Manufacturer Narrative
The legion cutting block was returned and evaluated.A visual inspection confirmed the complaint that a piece of the cutting block has sheared off; it was not returned with the device.Small burs were also found on the cutting slot guides.We recommend that all reusable instruments be routinely inspected for wear and damage so they can be replaced as necessary.A review of the complaint history revealed no additional complaints for the associated lot number.Reviewing the manufacturing records did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident.Based on this investigation, the need for corrective action is not indicated.Should additional information be received, the complaint will be reopened.We consider this investigation closed.

• Brand Name: LGN AP FEM CUTTING BLK SZ 7
• Common Device Name: PROSTHESIS, KNEE, FEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 8102710
• Report Number: 1020279-2018-02590
• Device Sequence Number: 1995237
• Product Code: HRY
• UDI-Device Identifier: 03596010549204
• UDI-Public: 03596010549204
• Combination Product (Y/N): N
• PMA/510(K) Number: K121393
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/19/2018

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 Catalogue Number: 71434412
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 11/01/2018
• Supplement Date Received by Manufacturer: 11/01/2018
• Initial Report FDA Received Date: 11/26/2018
• Supplement Report FDA Received Date: 12/19/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1