MAUDE Adverse Event Report: SMITH & NEPHEW, INC. INTERTAN 11.5MM X 38CM 130D LT; NAIL, FIXATION, BONE

Model Number	71675291
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Codes	Failure of Implant (1924); Injury (2348)
Date of Event	08/25/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a revision surgery of a broken nail was performed.This event occurred seven months after primary surgery.
Additional Manufacturer Narrative
Results of investigation: the device, used in treatment, was returned for evaluation.The clinical/medical team concluded, the information provided is insufficient to perform a thorough medical investigation of the reported revision.Should relevant medical information be provided, this complaint would be re-assessed.Therefore, no further clinical/medical assessment is warranted at this time.A visual inspection confirmed the intertan 11.5mm x 38cm 130d lt is fractured.A review of the manufacturing records did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident.At this time, we have no reason to suspect that the products failed to meet any product specifications at the time of manufacture.A review of complaint history for the listed part revealed no prior complaints for the listed batch.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.Based on this investigation, the need for corrective action is not indicated.Should additional information be received, the complaint will be reopened.No further investigation warranted for this complaint; however we will continue to monitor for future complaints and investigate as necessary.We consider this investigation closed.

• Brand Name: INTERTAN 11.5MM X 38CM 130D LT
• Common Device Name: NAIL, FIXATION, BONE
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• MDR Report Key: 10604427
• Report Number: 1020279-2020-04951
• Device Sequence Number: 2941356
• Product Code: JDS
• UDI-Device Identifier: 03596010561008
• UDI-Public: 03596010561008
• Combination Product (Y/N): N
• Initial Reporter Country: TU
• PMA/510(K) Number: K040212
• 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): 04/15/2021

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: Lay User/Patient
• Device Model Number: 71675291
• Device Catalogue Number: 71675291
• Device Lot Number: 17MM00986
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/03/2021
• Initial Date Received by Manufacturer: 09/01/2020
• Supplement Date Received by Manufacturer: 03/22/2021
• Initial Report FDA Received Date: 09/30/2020
• Supplement Report FDA Received Date: 04/15/2021
• 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; Required Intervention
• Patient Weight: 90