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

Device Problem Break (1069)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/28/2018

Event Type  malfunction  

Event 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.

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
• Type of Device: PROSTHESIS, KNEE, FEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 8192744
• MDR Text Key: 131304646
• Report Number: 1020279-2018-02882
• Device Sequence Number: 1
• Product Code: HRY
• UDI-Device Identifier: 03596010407368
• UDI-Public: 03596010407368
• Combination Product (y/n): N
• PMA/PMN Number: K121393
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 01/10/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/21/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: 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
• Date Manufacturer Received: 11/28/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention