MAUDE Adverse Event Report: SMITH & NEPHEW, INC. 3.5MM M-D TIB LK PL13H L 223MM; PLATE, FIXATION, BONE

Catalog Number	71801013
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the patient presented to theatre on the (b)(6) 2018 for removal of this metal work.According to the consultant, this patient sustained no injury to his leg; the plate "just broke".The consultant said the "plate was only in the patient for about 6 weeks and it broke".
Additional Manufacturer Narrative
The associated 3.5 mm medial distal tibial locking plate was returned and evaluated.A lab analysis conducted during this investigation noted that a microscopic examination of the device showed fracture surface and deformation on the threaded portion of the screw hole region.It concluded that due to the size of the plate, the fracture surface could not be evaluated using the sem.Therefore, the exact cause of the reported failure could not be determined.A review of the manufacturing records for the listed batch 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 failure mode with the same batch number.A clinical evaluation was performed and noted that no clinical/medical information has been provided.Based on the limited information, the breakage of the periloc plate could have been the non-union which ultimately required the second surgery.Without supporting clinical/medical documents a thorough investigation cannot be performed.No further investigation is warranted for this complaint; however we will continue to monitor for future complaints and investigate as necessary.We consider this investigation closed.Should additional information be received, the complaint will be reopened.

• Brand Name: 3.5MM M-D TIB LK PL13H L 223MM
• Common Device Name: PLATE, FIXATION, BONE
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 7708430
• Report Number: 1020279-2018-01341
• Device Sequence Number: 13706817
• Product Code: HRS
• UDI-Device Identifier: 03596010520623
• UDI-Public: 03596010520623
• Combination Product (Y/N): N
• Initial Reporter Country: EI
• 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: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/03/2019

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 Expiration Date: 03/27/2025
• Device Catalogue Number: 71801013
• Device Lot Number: 15CM20665
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 07/03/2018
• Supplement Date Received by Manufacturer: 07/03/2018
• Initial Report FDA Received Date: 07/20/2018
• Supplement Report FDA Received Date: 01/03/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 35 YR