MAUDE Adverse Event Report: SMITH & NEPHEW, INC. GII MI IN SLT 3 MO TI CU BL LT; PROSTHESIS, KNEE, FEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER

Model Number	71434331
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	07/29/2020
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during surgery the knob on the lgn tibial cutting block left ((b)(4)) broke off and is now locked on to gii non spike-fixation rod ((b)(4)).Device broke outside and all pieces were recovered, nothing fell inside the patient.A delay of less than 30 min was reported.S&n back up device was used to complete the procedure.
Event or Problem Description
It was reported that during surgery the knob on the gii mi in slt 3 mo ti cu bl lt broke off and is now locked on to the rod.Device broke outside and all pieces were recovered, nothing fell inside the patient.A delay of less than 30 min was reported.S&n back up device was used to complete the procedure.
Additional Manufacturer Narrative
H3, h6: the device, used in treatment, was returned for evaluation.A visual inspection of the returned device confirmed the stated failure mode.The knob on the device is fractured, and the fractured piece was returned, rendering the device inoperable.The device shows signs of extensive use.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 manufacturing records did not reveal any manufacturing or material abnormalities 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 complaints will be reopened.No further investigation is warranted for these complaints; however, we will continue to monitor for future complaints and investigate as necessary.We consider this investigation closed.

• Brand Name: GII MI IN SLT 3 MO TI CU BL LT
• Common Device Name: PROSTHESIS, KNEE, FEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• MDR Report Key: 10437657
• Report Number: 1020279-2020-04136
• Device Sequence Number: 14107936
• Product Code: HRY
• UDI-Device Identifier: 03596010549815
• UDI-Public: 03596010549815
• 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
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/07/2021

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: 71434331
• Device Catalogue Number: 71441136
• Device Lot Number: 04HM06826
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 07/30/2020
• Supplement Date Received by Manufacturer: 10/06/2020; 06/04/2021
• Initial Report FDA Received Date: 08/21/2020
• Supplement Report FDA Received Date: 10/08/2020; 06/07/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1