MAUDE Adverse Event Report: SMITH & NEPHEW, INC. INTERTAN 11.5MM X 18CM 130D; NAIL, FIXATION, BONE

Model Number	71675208
Medical Device Problem Codes	Break (1069); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	09/01/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a revision surgery was performed due to a nail breakage.The patient fell causing the device to break.In this surgery the lag and compression screws were removed.Initial surgery was performed 3 years ago.The outcome of the patient is unknown.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.
Additional Manufacturer Narrative
The device, used in treatment, was not returned for evaluation.Therefore, product analysis could not be performed at this time.So the reported event could not be confirmed.A medical investigation was conducted and confirms based on the information provided the root cause of the nail breakage is due to a fall occurring approximately 3 years post implantation.One single undated x-ray provided demonstrates a breakage of the nail at the lag screw hole; radiolucency is noted around the stem, which could have contributed to the breakage if loose.It cannot be concluded if the fall resulted in the broken nail or the broken nail resulted in the fall.Per communications, the patient¿s condition is unknown.Therefore, the impact to the patient beyond the reported fall, the subsequent revision and the post-op convalescence period cannot be determined.Should additional medical information be provided this complaint would be re-assessed.A review of complaint history did not reveal additional complaints for the listed batch.A review of the manufacturing records did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident.A review of risk management files and instructions for use found that the reported failure was documented appropriately.Some potential probable causes for this event could include but not limited to traumatic injury, surgical technique, implant failure or design of device.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: INTERTAN 11.5MM X 18CM 130D
• Common Device Name: NAIL, FIXATION, BONE
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• MDR Report Key: 10597404
• Report Number: 1020279-2020-04921
• Device Sequence Number: 16879171
• Product Code: JDS
• UDI-Device Identifier: 03596010560872
• UDI-Public: 03596010560872
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K040212
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/25/2021

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: 05/19/2026
• Device Model Number: 71675208
• Device Catalogue Number: 71675208
• Device Lot Number: 16ET69826
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 09/01/2020
• Supplement Date Received by Manufacturer: 06/24/2021
• Initial Report FDA Received Date: 09/28/2020
• Supplement Report FDA Received Date: 06/25/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: LAG AND COMPRESSION SCREWS
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 74 YR