MAUDE Adverse Event Report: SMITH & NEPHEW, INC. GNS II CUTTING BLOCK SIZE 7; PROSTH, KNEE, PATE/FEMOROTIBIAL, SEMI-CONST, UNCEM, PORO, COAT, POLY/METAL/POLY

Model Number	71440092
Medical Device Problem Code	Naturally Worn (2988)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/17/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a tka the block of a genesis ii cutting block size 7 was damaged, preventing the sawblade to fit through the cutting slot.The procedure was completed successfully with a backup device and with no significant delays.There were no injuries reported.
Additional Manufacturer Narrative
The information received by the manufacturer has been re-evaluated for mdr reporting and it was determined that this case does not meet the threshold for reporting and is a non-reportable event.If further details are provided confirming the occurrence of a reportable event, our files will be updated accordingly and a further report submitted outlining both the event details and our investigations performed.

• Brand Name: GNS II CUTTING BLOCK SIZE 7
• 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: 11646914
• Report Number: 1020279-2021-02875
• Device Sequence Number: 3397517
• Product Code: MBH
• UDI-Device Identifier: 03596010213952
• UDI-Public: 03596010213952
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K121393
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/24/2021

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: 71440092
• Device Catalogue Number: 71440092
• Device Lot Number: TBD
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 03/17/2021
• Supplement Date Received by Manufacturer: 03/17/2021
• Initial Report FDA Received Date: 04/11/2021
• Supplement Report FDA Received Date: 08/24/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1