MAUDE Adverse Event Report: SMITH & NEPHEW, INC. GII POST REF A/P BLK SZ 7; PROSTHESIS, KNEE, FEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER

Catalog Number	71440822
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/28/2018
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the cutting block ties broke off during the case.No harm to patient or staff reported.There was no backup available, the procedure was completed with no delay.
Additional Manufacturer Narrative
The associated complaint device was returned and evaluated.A visual inspection of the returned gii post ref block indicated that the cutting block exhibited wear in each of the cutting slots and damage to the impactor connection point which are consistent with product use.The cutting block bone spikes fractured at the cutting block interface.The fracture of the bone spikes is likely due to stresses in excess of its material properties being applied to the bone spike during use.This device was manufactured in 2013, showing sign of wear/use.A review of 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.No further investigation is warranted for this complaint; however we will continue to monitor for future complaints and investigate further as necessary.Should additional information be received, the complaint will be reopened.We consider this investigation closed.

• Brand Name: GII POST REF A/P 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: 8192744
• Report Number: 1020279-2018-02882
• Device Sequence Number: 2026624
• Product Code: HRY
• UDI-Device Identifier: 03596010407368
• UDI-Public: 03596010407368
• Combination Product (Y/N): N
• 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: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/10/2019

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: 71440822
• Device Lot Number: 13MM02214
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/10/2018
• Initial Date Received by Manufacturer: 11/28/2018
• Supplement Date Received by Manufacturer: 11/28/2018
• Initial Report FDA Received Date: 12/21/2018
• Supplement Report FDA Received Date: 01/10/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention