MAUDE Adverse Event Report: SMITH & NEPHEW, INC. LGN SCW LWDG TRL S6 10D X 10P; PROSTHESIS,KNEEPATELLOFEMOROTIBIAL,SEMICONSTRAIND,CMNTD,POLYMR/METAL/POLYMR

Catalog Number	71431754
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	04/23/2018
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during a revision surgery, the screw broke off wedge and is stuck in femoral component.
Additional Manufacturer Narrative
The associated device was returned and evaluated.A visual examination of the returned legion screw wedge trial indicated that the screw top and bottom were missing, confirming the stated complaint.A review of the manufacturing records did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident.A clinical analysis indicated that no clinical relevant documents were provided to conduct a thorough medical assessment.No medical assessment is warranted at this time.This complaint will be re-evaluated if more information becomes available.A review of complaint history did not reveal additional complaints for the listed part.We recommend that all reusable instruments be routinely inspected for wear and damage and replaced as necessary.No further investigation is warranted for this complaint; however we will continue to monitor for future complaints and investigate further as necessary.Based on this investigation, the need for corrective action is not indicated.Should additional information be received, the complaint will be reopened.We consider this investigation closed.

• Brand Name: LGN SCW LWDG TRL S6 10D X 10P
• Common Device Name: PROSTHESIS,KNEEPATELLOFEMOROTIBIAL,SEMICONSTRAIND,CMNTD,POLYMR/METAL/POLYMR
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 7528417
• Report Number: 1020279-2018-00959
• Device Sequence Number: 275897
• Product Code: JWH
• UDI-Device Identifier: 03596010545961
• UDI-Public: 03596010545961
• Combination Product (Y/N): N
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/20/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Catalogue Number: 71431754
• Device Lot Number: 10LSM0040
• Initial Date Received by Manufacturer: 04/23/2018
• Supplement Date Received by Manufacturer: 04/23/2018
• Initial Report FDA Received Date: 05/19/2018
• Supplement Report FDA Received Date: 06/21/2018
• 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: Other