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

Catalog Number	71800013
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Injury (2348)
Date of Event	08/10/2018
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a revision surgery was performed since the periloc l-d femoral plate has broken.
Additional Manufacturer Narrative
The associated complaint devices were returned and evaluated.The lab analysis concluded, 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.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 part revealed no prior complaints for the listed batch.The clinical/medical team concluded, no clinical relevant information has been provided to perform a thorough analysis of this issue.Based on the lab analysis of the explanted component, the root cause of the plate breakage could not be determined.No further clinical assessment of this case is warranted at this time.At this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.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: 4.5MM L-D FEM LK PL13H L 286MM
• Common Device Name: PLATE, FIXATION, BONE
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 7856984
• Report Number: 1020279-2018-01751
• Device Sequence Number: 1129983
• Product Code: HRS
• UDI-Device Identifier: 03596010520036
• UDI-Public: 03596010520036
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K092015
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/26/2018

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: 71800013
• Device Lot Number: UNKNOWN
• Initial Date Received by Manufacturer: 08/13/2018
• Supplement Date Received by Manufacturer: 08/13/2018
• Initial Report FDA Received Date: 09/07/2018
• Supplement Report FDA Received Date: 12/26/2018
• 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; Required Intervention