MAUDE Adverse Event Report: SMITH & NEPHEW, INC. 4.5MM L-D FEM LK PL16H L 342MM; PLATE, FIXATION, BONE

Catalog Number	71800016
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Injury (2348)
Date of Event	09/18/2018
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported a distal locking plate has broken inside the patient.The device was removed from the patient.
Additional Manufacturer Narrative
The associated complaint device was not returned.A clinical evaluation was conducted and no clinically relevant or supporting documentation was provided; therefore a thorough medical investigation could not be performed.Although plate breakage at 4 weeks post-op is a possible occurrence with early weight bearing/activity in the presence of non-union, no supporting imaging or documentation has been provided.The patient impact beyond the reported revision surgery itself, probable pain, and an expected post-op convalescence period cannot be determined.No further medical assessment is warranted at this time.A review of complaint history on the listed part revealed no prior complaints for the listed batch with the same failure mode.A review of the manufacturing records did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident.Without the actual product involved and/or device information, our investigation cannot proceed.If the device or new information is received in the future, this complaint can be re-opened.No further actions are being taken at this time.We consider this investigation closed.

• Brand Name: 4.5MM L-D FEM LK PL16H L 342MM
• Common Device Name: PLATE, FIXATION, BONE
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 7962892
• Report Number: 1020279-2018-02165
• Device Sequence Number: 13864234
• Product Code: HRS
• UDI-Device Identifier: 03596010520043
• UDI-Public: 03596010520043
• 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 Implanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/10/2019

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: 71800016
• Device Lot Number: 17LM17258
• Initial Date Received by Manufacturer: 09/18/2018
• Supplement Date Received by Manufacturer: 09/18/2018
• Initial Report FDA Received Date: 10/12/2018
• Supplement Report FDA Received Date: 01/10/2019
• 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