MAUDE Adverse Event Report: SMITH & NEPHEW, INC. GII SLT 3 MOD TIB CUTBLCK LT; PROSTHESIS, KNEE, FEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER

Catalog Number	71440209
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/20/2019
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during surgery, the device was found broken.The pin and the locking part were disassembled.The device will be returned for evaluation.No more information is available.
Additional Manufacturer Narrative
The associated device was returned and evaluated.A visual inspection of the returned cutting block confirms the pin that connects the cam and the slotted tibial cutting block broke away from the device.All the pieces of the device was returned.This device exhibits signs of significant wear/usage.This device was manufactured in 2002.A review of complaint history on the listed part revealed no prior complaints for the listed batch with the same failure mode.A review of the manufacturing records did not reveal any manufacturing or material abnormalities that could have caused or contributed to the reported incident.We recommend that all reusable instruments be routinely inspected for wear and damage and replaced as necessary.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.

• Brand Name: GII SLT 3 MOD TIB CUTBLCK LT
• 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: 9151286
• Report Number: 1020279-2019-03547
• Device Sequence Number: 14185148
• Product Code: HRY
• UDI-Device Identifier: 03596010460431
• UDI-Public: 03596010460431
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K121393
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,u
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/23/2019

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 Expiration Date: 08/14/2012
• Device Catalogue Number: 71440209
• Device Lot Number: 02HM04540
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/09/2019
• Initial Date Received by Manufacturer: 09/20/2019
• Supplement Date Received by Manufacturer: 09/20/2019
• Initial Report FDA Received Date: 10/03/2019
• Supplement Report FDA Received Date: 12/23/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1