MAUDE Adverse Event Report: SMITH & NEPHEW, INC. LEGION HINGE TIBIAL STABILIZING TOOL; TOTAL KNEE SYSTEM INSTRUMENTATION

Catalog Number 71434465

Device Problems Break (1069); Detachment Of Device Component (1104); Entrapment of Device (1212)

Patient Problem No Code Available (3191)

Event Date 05/10/2016

Event Type  Injury  

Manufacturer Narrative

(b)(4).

Event Description

It was reported the instrument stem snapped off and became stuck in implant.No revision is planned to remove component in patient as of date.

Manufacturer Narrative

The associated complaint device was returned and evaluated.A visual inspection found the peg/connector is broken off, but the broken piece was not returned with the device.The device exhibits signs of wear/usage.The manufacturing records did not reveal any manufacturing or material abnormalities that could have caused or contributed to the reported incident.The device was manufactured in 2013.A review of complaint history revealed no prior complaints for the listed lot or failure mode.The clinical/medical team concluded, no injury or impact to patient is being reported.Additionally, the device was not returned for evaluation.No further clinical assessment is warranted at this time.We recommend that all re-usable instruments be routinely inspected for wear/damage and replaced as necessary.At this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.This investigation could not verify or identify any evidence of product contribution to the reported problem.Based on this investigation, the need for corrective action is not indicated.Should additional information be received, the complaint will be reopened.

• Brand Name: LEGION HINGE TIBIAL STABILIZING TOOL
• Type of Device: TOTAL KNEE SYSTEM INSTRUMENTATION
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• Manufacturer (Section G): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• Manufacturer Contact: yagna angirish ; 1450 brooks rd; memphis, TN 38116 ; 9013995009
• MDR Report Key: 5688804
• MDR Text Key: 46207100
• Report Number: 1020279-2016-00433
• Device Sequence Number: 1
• Product Code: MBH
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K121393
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 05/10/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/31/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 71434465
• Device Lot Number: 13FEM0024
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/10/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/14/2013
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Other