MAUDE Adverse Event Report: SMITH & NEPHEW, INC. CLASSIC PLATTE 4-LOCH 135 AO; APPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, MULTIPLE COMPONENT

Model Number	71970533
Medical Device Problem Code	Fitting Problem (2183)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/16/2019
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during surgery, the plate would not fit over the lag screw.The lag screw was removed and the surgeon still had difficulty getting the plate to fit over the screw.The screw was once again inserted and eventually forced over lag screw.There was a delay over 30 minutes due to this issue.No patient injuries reported.
Additional Manufacturer Narrative
It was reported that during surgery, the plate would not fit over the lag screw.The lag screw was removed and the surgeon still had difficulty getting the plate to fit over the screw.The screw was once again inserted and eventually forced over lag screw.The affected classic platte, used in treatment, was not returned for evaluation as it remained implanted.After repeated requests, smith and nephew has been unable to obtain the device information.As device details were not made available, device history record review cannot be completed.There is no information that would suggest the device failed to meet specifications.A relationship, if any, between the device and the reported incident could not be corroborated.It was communicated that the patient is doing well.Based on this investigation, the need for corrective action is not indicated.A complaint history review found related failures; this failure mode will be monitored for future complaints for any necessary corrective actions.Some potential causes could include but is not limited to user/procedural variance, improper size of device used or unclear user instructions.Without the return of the actual product involved, our investigation of this report is inconclusive.No further investigation is warranted for this complaint; however we will continue to monitor for future complaints and investigate as necessary.

• Brand Name: CLASSIC PLATTE 4-LOCH 135 AO
• Common Device Name: APPLIANCE, FIXATION, NAIL/BLADE/PLATE COMBINATION, MULTIPLE COMPONENT
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 9474119
• Report Number: 1020279-2019-04406
• Device Sequence Number: 16809308
• Product Code: KTT
• UDI-Device Identifier: 03596010415301
• UDI-Public: 03596010415301
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K993289
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/26/2020

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 Model Number: 71970533
• Device Catalogue Number: 71970533
• Initial Date Received by Manufacturer: 11/19/2019
• Supplement Date Received by Manufacturer: 05/13/2020
• Initial Report FDA Received Date: 12/16/2019
• Supplement Report FDA Received Date: 05/26/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1