MAUDE Adverse Event Report: SMITH & NEPHEW, INC. GII FEM LUG PUNCH; PROSTHESIS, KNEE, FEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER

Catalog Number	71440183
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	09/24/2018
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during tka the lug punch got stuck in the "up" position.Broke in patient while impacting the femur.All pieces accounted for.No delay or injury reported.Procedure finished with the same device.
Additional Manufacturer Narrative
The associated complaint device was not returned.The photo provided could not confirm the stated failure.A review of complaint history for the listed part revealed no prior complaints for the listed batch/failure mode.We recommend that all re-usable instruments be routinely inspected for wear/damage and replaced as necessary.Without the actual product involved, our investigation cannot proceed.If the device or new information is received in the future, this complaint can be re-opened.We consider this investigation closed.

• Brand Name: GII FEM LUG PUNCH
• 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: 8062400
• Report Number: 1020279-2018-02431
• Device Sequence Number: 19192346
• Product Code: HRY
• UDI-Device Identifier: 03596010329868
• UDI-Public: 03596010329868
• Combination Product (Y/N): N
• Initial Reporter State: MN
• 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: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/12/2018

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 Expiration Date: 08/03/2014
• Device Catalogue Number: 71440183
• Device Lot Number: 04FM12179
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 11/09/2018
• Supplement Date Received by Manufacturer: 11/09/2018
• Initial Report FDA Received Date: 11/12/2018
• Supplement Report FDA Received Date: 12/12/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1