MAUDE Adverse Event Report: SMITH & NEPHEW, INC. META-NAIL TIBIAL 13MM X 30CM; NAIL, FIXATION, BONE

Model Number	71655330
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	02/06/2020
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during surgery, after hitting the nail with a hammer for insertion, the tibial distal canopy was damaged.Surgeon did not noticed that the nail stuck the tibial bone.It was confirmed with the x-ray image and the ct image after the operation that the nail stuck out from both sides of the tibial bone.There was a 15 minutes delay.On (b)(6) 2020, the patient complained of pain.The nail is still inside the patient.No plan for revision surgery at this moment.The surgeons think this issue occurred due to their mistakes of nail length choice.
Additional Manufacturer Narrative
The device, used in treatment was not returned for evaluation.A clinical evaluation was conducted and confirms the reported pain is related to the nail extending through the tibia, which was caused by surgeon error and is not related to a malperformance of the component.To date no revision has been reported.The patient impact beyond the pain cannot be determined.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 device history records for the listed batch did not reveal any deviation from the standard manufacturing processes.Possible probable cause could include but not limited the user error.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.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: META-NAIL TIBIAL 13MM X 30CM
• Common Device Name: NAIL, FIXATION, BONE
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 9720548
• Report Number: 1020279-2020-00617
• Device Sequence Number: 2353295
• Product Code: JDS
• UDI-Device Identifier: 03596010612908
• UDI-Public: 03596010612908
• Combination Product (Y/N): N
• PMA/510(K) Number: K061019
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/03/2020

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: 71655330
• Device Catalogue Number: 71655330
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 02/07/2020
• Supplement Date Received by Manufacturer: 05/26/2020
• Initial Report FDA Received Date: 02/18/2020
• Supplement Report FDA Received Date: 06/03/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1