MAUDE Adverse Event Report: SMITH & NEPHEW, INC. INTERTAN 10MM X 24CM 125D; NAIL, FIXATION, BONE

Model Number	71934479
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	02/17/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that, an intertan 10mm x 24cm 125d broke inside the patient, proximally just above the lag screw.A revision surgery was performed and the device was removed.No further complications were reported.
Additional Manufacturer Narrative
The device, used in treatment, was returned for evaluation a lab analysis conducted during this investigation, it was concluded that the intertan 10mm x 24cm 125d nail fractured by the initiation and subsequent propagation of tensile forces and shear forces.The fracture likely initiated on the lateral side of the nail through the lag screw hole.The shear forces quickly propagated in a quasi-static manner to an extent that the cross-sectional area of the nail could not bear the imposed loading, which led to an overload fracture of the nail.No material deviations were found during this investigation.A medical investigation was conducted and confirms without the requested clinical information, operative reports or radiographs a thorough medical investigation of the reported breakage cannot be rendered, nor can its root cause be determined.Per e-mail from the sales rep., one surgeon performed the initial surgery and another surgeon performed the revision.Although the revision report was not provided, it was reported, during the revision the broken device was removed.Since no further complications were reported, no further clinical/medical assessment is warranted at this time.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 or implant failure.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.Should additional information be received, the complaints will be reopened.No further investigation is warranted for these complaints; however we will continue to monitor for future complaints and investigate as necessary.

• Brand Name: INTERTAN 10MM X 24CM 125D
• Common Device Name: NAIL, FIXATION, BONE
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• MDR Report Key: 11478934
• Report Number: 1020279-2021-02092
• Device Sequence Number: 3625372
• Product Code: JDS
• UDI-Device Identifier: 00885556105092
• UDI-Public: 00885556105092
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: K040212
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/27/2021

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 Model Number: 71934479
• Device Catalogue Number: 71934479
• Device Lot Number: 20DM09591
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/25/2021
• Initial Date Received by Manufacturer: 02/17/2021
• Supplement Date Received by Manufacturer: 08/25/2021
• Initial Report FDA Received Date: 03/14/2021
• Supplement Report FDA Received Date: 08/27/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Other; Required Intervention