MAUDE Adverse Event Report: SMITH & NEPHEW, INC. LGN TIBIAL CUTTING BLOCK RIGHT; PROSTHESIS, KNEE, FEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER

Catalog Number	71434332
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	02/04/2019
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a tka procedure, trocar pin cold welded to cutting block.Surgeon pulled the tibia cutting block off and free handed the tibia cut.No delay.No revision surgery performed.Procedure was completed with the same device.No injury or impact to patient reported.
Additional Manufacturer Narrative
The associated devices were returned and evaluated.A visual / functional inspection of the returned devices confirmed the stated failure mode.A pin was stuck in one of the fixation holes.The fixation holes were damaged with many burrs and score marks from repeated use.The pin was also damaged from the attempted use in the damaged fixation holes.The devices were manufactured in 2006 and 2018 and exhibit signs of extensive wear / usage.A dimensional inspection was attempted on the fixation holes but they were too damaged to obtain accurate measurements.A review of complaint history did not reveal additional complaints for the listed batches.At this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.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 complaint will be reopened.No further investigation is warranted for this complaint; however we will continue to monitor for future complaints and investigate as necessary.

• Brand Name: LGN TIBIAL CUTTING BLOCK RIGHT
• 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: 8370814
• Report Number: 1020279-2019-00818
• Device Sequence Number: 1203719
• Product Code: HRY
• UDI-Device Identifier: 03596010549822
• UDI-Public: 03596010549822
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/07/2019

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: 71434332
• Device Lot Number: 06DM11713
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/22/2019
• Initial Date Received by Manufacturer: 02/04/2019
• Supplement Date Received by Manufacturer: 02/04/2019
• Initial Report FDA Received Date: 02/26/2019
• Supplement Report FDA Received Date: 03/07/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: 71210003/18DSM0217