MAUDE Adverse Event Report: SMITH & NEPHEW, INC. INTERTAN 10MM X 38CM 130D RT; NAIL, FIXATION, BONE

Model Number	71675270
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	04/23/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that, after a trauma procedure on (b)(6) 2019, a revision surgery was performed on (b)(6) 2021 to exchange a intertan 10mm x 38cm 130d rt because it was broken.The current health status of the patient is unknown.No further information is available.
Additional Manufacturer Narrative
The device, used in treatment, was not returned for evaluation but the pictures were reviewed, and the fracture was confirmed.The clinical/medical investigation concluded that, based on the information provided, the root cause of the reported event could not be definitively concluded, although bone quality could not be ruled out as a potential contributing factor.The assessed patient impact was the implant fracture and subsequent revision.Further patient impact could not be assessed.No further medical assessment could be rendered at this time.Should additional clinical documentation and/or relevant product evaluation results become available in the future, the clinical/medical task may be re-evaluated.A review of the 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 the risk management file and instructions for use documents revealed this failure mode was previously identified.At this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.Some potential probable causes for this event could include but not limited to traumatic injury, abnormal loading of limb or excessive forces applied to implant.Based on this investigation, the need for corrective action is not indicated.Should the device or additional information be received, the complaint will be reopened.No further investigation is 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 10MM X 38CM 130D RT
• Common Device Name: NAIL, FIXATION, BONE
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• MDR Report Key: 11832566
• Report Number: 1020279-2021-04356
• Device Sequence Number: 11822947
• Product Code: JDS
• UDI-Device Identifier: 03596010560933
• UDI-Public: 03596010560933
• Combination Product (Y/N): N
• Initial Reporter Country: SF
• PMA/510(K) Number: K040212
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2021
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/16/2021

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: 71675270
• Device Catalogue Number: 71675270
• Device Lot Number: 19ET22006
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 04/27/2021
• Supplement Date Received by Manufacturer: 08/12/2021
• Initial Report FDA Received Date: 05/17/2021
• Supplement Report FDA Received Date: 08/16/2021
• 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