MAUDE Adverse Event Report: SMITH & NEPHEW, INC. 4.5MM L-D FEM LK PL13H R 286MM; PLATE, FIXATION, BONE

Catalog Number	71800113
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Injury (2348)
Date of Event	12/13/2018
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that an x-ray showed callus formation and a plate broken.
Additional Manufacturer Narrative
The associated complaint device was returned and evaluated.The lab analysis concluded, the purpose of this investigation was to examine the returned device.No destructive analysis was conducted.Due to the size of the plate, the fracture surface was unable to be evaluated using the sem.From the analyses conducted during this investigation, the exact cause of the reported failure was not able to be determined.The clinical/medical investigation task will be reopened.Details regarding the patient¿s weight-bearing status, medical history, bone quality, fall/trauma history, and other additional clinical relevant information have not been provided.The x-rays provided 2 months prior to the broken plate and confirm the callus formation of the distal femur and the bone is attempting to heal but there is still nonunion present.A product analysis was unable to determine the exact cause of the reported broken plate.The future impact to the patient cannot be determined.Stress fatigue was the likely cause of the plate broken but the product eval couldn¿t confirm this.No further clinical/medical assessment is warranted at this time.A review of the production documentation for the corresponding products did not reveal any deviation from the standard manufacturing processes.A review of complaint history for the listed part revealed no prior complaints for the listed batch.If new information is received in the future, this complaint can be re-opened.

• Brand Name: 4.5MM L-D FEM LK PL13H R 286MM
• Common Device Name: PLATE, FIXATION, BONE
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 8244502
• Report Number: 1020279-2019-00149
• Device Sequence Number: 2141878
• Product Code: HRS
• UDI-Device Identifier: 03596010520098
• UDI-Public: 03596010520098
• Combination Product (Y/N): N
• Initial Reporter Country: SW
• PMA/510(K) Number: K092015
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,u
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 05/15/2019

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: 71800113
• Device Lot Number: 17MM04314
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/15/2019
• Initial Date Received by Manufacturer: 12/17/2018
• Supplement Date Received by Manufacturer: 12/17/2018
• Initial Report FDA Received Date: 01/14/2019
• Supplement Report FDA Received Date: 05/15/2019
• 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: Hospitalization; Required Intervention
• Patient Age: 78 YR