MAUDE Adverse Event Report: SMITH & NEPHEW, INC. META-NAIL TIBIAL 8.5MM X 36CM; NAIL, FIXATION, BONE

Model Number	71655036
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Injury (2348)
Date of Event	09/24/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a patient had a tibial nail inserted approx 5 months ago.Due to delayed union dr.Decided to exchange the nail for one with a larger diameter.
Additional Manufacturer Narrative
The device, used in treatment was not returned for evaluation, reporting event could not be confirmed.A clinical evaluation was conducted and confirms the photo of the nail provided was reviewed.Per subsequent email, it was reported the device did not fail.However, without the relevant clinical documents, a thorough medical investigation cannot be rendered nor can the impact to the patient be determined.Therefore, no further clinical/medical assessment is warranted at this time.Should any additional medical information be provided, this complaint will be re-assessed.A review of the device history records for the listed batch did not reveal any deviation from the standard manufacturing processes.At this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.A review of complaint history on the listed part revealed no prior complaints for the listed batch with the same failure mode.Factors and/or potential causes that could contribute to the reported event have been identified in the risk management file, include but not limited to improper size of device used, surgical technique, unclear user instructions, and procedural/user error.

• Brand Name: META-NAIL TIBIAL 8.5MM X 36CM
• Common Device Name: NAIL, FIXATION, BONE
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 9234033
• Report Number: 1020279-2019-03720
• Device Sequence Number: 398816
• Product Code: JDS
• UDI-Device Identifier: 03596010585509
• UDI-Public: 03596010585509
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K061019
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2000
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/11/2020

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 Model Number: 71655036
• Device Catalogue Number: 71655036
• Device Lot Number: 18HM21569
• Initial Date Received by Manufacturer: 09/24/2019
• Supplement Date Received by Manufacturer: 08/07/2020
• Initial Report FDA Received Date: 10/24/2019
• Supplement Report FDA Received Date: 08/11/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1