MAUDE Adverse Event Report: SMITH & NEPHEW, INC. LGN CONE IMPACTOR HANDLE; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED

Catalog Number	71442011
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Date of Event	06/20/2017
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported while surgeon was broaching with a 28 mm long tibial cone broach, the handle broke and became detached from the broach.One piece of the broken handle was retained.The other small fragment is believed to be in the patient's intramedullary tibial canal.
Additional Manufacturer Narrative
The associated complaint device was returned for evaluation.Based on the limited clinical information provided, the patient impact cannot be fully assessed as it remains unknown if (and/or where) the fragment/foreign body remains in the patient.No further medical assessment can be rendered at this time.Examination of the impactor tip fracture surface showed that the failure was likely caused by an overload fracture.This can occur when the stresses placed on the impactor tips exceed the yield strength of the material.A review of the manufacturing records did not reveal any manufacturing abnormalities that could have caused or contributed to the reported incident.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.Should additional information be received, the complaint will be reopened.We consider this investigation closed.

• Brand Name: LGN CONE IMPACTOR HANDLE
• Common Device Name: PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 6952219
• Report Number: 1020279-2017-00868
• Device Sequence Number: 13731089
• Product Code: JWH
• UDI-Device Identifier: 00885556537152
• UDI-Public: 00885556537152
• Combination Product (Y/N): N
• Initial Reporter State: NE
• Initial Reporter Country: US
• PMA/510(K) Number: K162775
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/16/2017

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: 71442011
• Device Lot Number: 17CSC0008
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 06/20/2017
• Supplement Date Received by Manufacturer: 06/20/2017
• Initial Report FDA Received Date: 10/16/2017
• Supplement Report FDA Received Date: 09/04/2018
• 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: 71441914/17APG0097
• Outcome Attributed to Adverse Event: Other
• Patient Age: 75 YR