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

Catalog Number	71675208
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Bone Fracture(s) (1870); Injury (2348)
Date of Event	07/21/2017
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported revision surgery was performed to remove broken nail.
Additional Manufacturer Narrative
Please review attached for investigation results.(b)(4).
Additional Manufacturer Narrative
This complaint has re-opened upon receipt of medical records.A clinical evaluation indicated that the patient¿s multiple comorbidities, including the left-sided deficit, cannot be excluded as contributors to the patient¿s initial fall and fracture.The broken nail and subsequent revision are due to the reported non-union from the non-healing bone as well as continued weight bearing is the likely root cause to the fatigue failure of the nail.The patient impact beyond the reported revision cannot be determined.No further clinical assessment is warranted at this time.No information regarding the current patient status has been reported.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 11.5MM X 18CM 130D
• Common Device Name: NAIL, FIXATION, BONE
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 6763722
• Report Number: 1020279-2017-00586
• Device Sequence Number: 1412822
• Product Code: JDS
• UDI-Device Identifier: 03596010560872
• UDI-Public: 03596010560872
• Combination Product (Y/N): N
• 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: 2017
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 02/25/2019

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 Expiration Date: 05/19/2026
• Device Catalogue Number: 71675208
• Device Lot Number: 16ET69823
• Initial Date Received by Manufacturer: 07/21/2017
• Supplement Date Received by Manufacturer: 07/21/2017; 07/21/2017
• Initial Report FDA Received Date: 08/03/2017
• Supplement Report FDA Received Date: 12/26/2017; 02/25/2019
• 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