MAUDE Adverse Event Report: SMITH & NEPHEW, INC. FAN ROSE 10 X 42 RT W/25 DEG DH; NAIL, FIXATION, BONE

Catalog Number	71934786
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Information (3190)
Date of Event	05/21/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that, six weeks after implantation of a femoral antegrade nail rose, it broke at the inferior proximal screw hole.It is unknown how the event has been managed since the finding.The patient outcome is unknown.
Additional Manufacturer Narrative
The associated device, used in treatment, was returned and evaluated.A visual inspection of the returned device confirmed the stated failure mode.The device fractured at one of the fixation holes in the proximal end.The fracture site is heavily worn with deformation inside the fixation hole.Four screws were also returned with the device.The device was manufactured in 2019.The medical investigation concluded that, per complaint details, the nail broke at the inferior proximal screw hole six weeks post implantation.The product evaluation reported that the findings supported the failure mode and that it is addressed in the ifu.Without the requested medical documentation, the definitive root cause could not be concluded; however, excessive weight bearing and/or trauma are known potential contributing factors.The patient impact beyond the explantation could not be determined, as the patient outcome was reportedly unknown.No further medical assessment is warranted at this time.Should the requested medical documentation become available, the medical assessment task may be re-evaluated.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.At this time, we do not have reason to suspect that the product failed to meet any product specifications at the time of manufacture.A review of the risk management file and instructions for use documents revealed this failure mode was previously identified.Some potential probable causes for this event could include overuse or a traumatic injury.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 is warranted for this complaint; however, we will continue to monitor for future complaints and investigate as necessary.

• Brand Name: FAN ROSE 10 X 42 RT W/25 DEG DH
• Common Device Name: NAIL, FIXATION, BONE
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• MDR Report Key: 10172833
• Report Number: 1020279-2020-02585
• Device Sequence Number: 11301109
• Product Code: JDS
• UDI-Device Identifier: 00885556298190
• UDI-Public: 885556298190
• Combination Product (Y/N): N
• Initial Reporter State: SC
• Initial Reporter Country: US
• PMA/510(K) Number: K981529
• 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): 08/06/2020

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: 71934786
• Device Lot Number: 19HM12118
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/27/2020
• Initial Date Received by Manufacturer: 05/21/2020
• Supplement Date Received by Manufacturer: 08/05/2020
• Initial Report FDA Received Date: 06/19/2020
• Supplement Report FDA Received Date: 08/06/2020
• 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