MAUDE Adverse Event Report: SMITH & NEPHEW, INC. INTERTAN 10MM X 34CM 130D RT; NAIL, FIXATION, BONE

Catalog Number	71675266
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Injury (2348)
Date of Event	05/04/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a revision surgery was performed on the patient due to the breakage of the intertan nail.
Additional Manufacturer Narrative
The associated complaint device was not returned.A clinical evaluation was conducted and the fluoroscopy photo provided confirm the breakage of the intertan nail ,but based on the limited information provided, the limited view of the image, and without the return of the device for evaluation the root cause of the broken intertan nail cannot be determined.The impact to the patient beyond the revision cannot be concluded.Should additional information becomes available this issue can be re-elevated.No further clinical assessment is warranted at this time.A review of complaint history on the listed part revealed no prior complaints for the listed batch with the same failure mode.A review of the manufacturing records did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident.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.

• Brand Name: INTERTAN 10MM X 34CM 130D RT
• Common Device Name: NAIL, FIXATION, BONE
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 8643563
• Report Number: 1020279-2019-02072
• Device Sequence Number: 19460628
• Product Code: JDS
• UDI-Device Identifier: 03596010560896
• UDI-Public: 03596010560896
• Combination Product (Y/N): N
• Initial Reporter Country: SA
• PMA/510(K) Number: K040212
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,u
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/23/2019

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 Catalogue Number: 71675266
• Device Lot Number: 14AM05813
• Initial Date Received by Manufacturer: 05/06/2019
• Supplement Date Received by Manufacturer: 05/06/2019
• Initial Report FDA Received Date: 05/27/2019
• Supplement Report FDA Received Date: 10/23/2019
• 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: 60