MAUDE Adverse Event Report: SMITH & NEPHEW, INC. META-NAIL TIBIAL 11.5MM X 40CM; NAIL, FIXATION, BONE

Model Number	71655240
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Injury (2348)
Date of Event	10/04/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that as a result of non-union of a fracture dr.Removed a tibial nail and did an orif using an evos plate.He was confident there was no failure of the implant.Revision surgery required to improve pt outcome.The device did not actually cause any harm to the patient.
Additional Manufacturer Narrative
It was reported that a revision surgery was performed due to non-union of a fracture the surgeon removed a tibial nail and did an orif using an evos plate.The affected trigen meta-nail, used in treatment, was not returned for evaluation.Therefore a product analysis could not be performed.Our investigation including a review of the manufacturing records for the listed batch did not reveal any deviation from the standard manufacturing processes.A review of the complaint history for the listed part revealed no prior complaints for the listed failure mode with the same batch number.At this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.A relationship, if any, between the device and the reported incident could not be corroborated.A review of instructions for use revealed the alleged failure is previously identified in the possible adverse effects.Probable causes could include but not limited to abnormal loading of limb, bone quality, lack of ingrowth, patient anatomy or abnormal motion over time.No medical documents were received for investigation.It has been communicated that the doctor does not fault the device as he ¿was confident there was no failure of the implant¿.No further medical assessment can be performed at this time.Without the return of the actual product involved and no patient medical records available, our investigation of this report is inconclusive.Based on this investigation, the need for corrective action is not indicated.No further investigation is warranted for this complaint; however smith and nephew will continue to monitor for future complaints and investigate as necessary.Should the device or additional information be received, the complaint will be reopened.

• Brand Name: META-NAIL TIBIAL 11.5MM X 40CM
• Common Device Name: NAIL, FIXATION, BONE
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 9263940
• Report Number: 1020279-2019-03855
• Device Sequence Number: 14393529
• Product Code: JDS
• UDI-Device Identifier: 03596010585714
• UDI-Public: 03596010585714
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• 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): 02/14/2020

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 Expiration Date: 03/15/2020
• Device Model Number: 71655240
• Device Catalogue Number: 71655240
• Device Lot Number: 10CM11209
• Initial Date Received by Manufacturer: 10/04/2019
• Supplement Date Received by Manufacturer: 02/08/2020
• Initial Report FDA Received Date: 10/31/2019
• Supplement Report FDA Received Date: 02/14/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1