MAUDE Adverse Event Report: SMITH & NEPHEW, INC. CONQUEST FN 7.5X110MM P-L SCR 25MM THD; DEVICE, FIXATION, PROXIMAL FEMORAL, IMPLANT

Model Number	75807210
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Injury (2348)
Date of Event	04/05/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a revision surgery was performed due to a fractured screw as well as it was backing out proximally.
Additional Manufacturer Narrative
The device, used in treatment, was not returned for evaluation and the reported event could not be confirmed.The clinical / medical investigation concluded that no relevant clinical information was provided for inclusion in this investigation.Should any additional medical information be provided this complaint will be re-assessed.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 have no 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 of the reported event could include inadequate static or fatigue strength.Based on this investigation, the need for corrective action is not indicated.Without the return of the actual product involved, our investigation could not proceed.Should the device or 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.

• Brand Name: CONQUEST FN 7.5X110MM P-L SCR 25MM THD
• Common Device Name: DEVICE, FIXATION, PROXIMAL FEMORAL, IMPLANT
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 9363710
• Report Number: 1020279-2019-04146
• Device Sequence Number: 16951812
• Product Code: JDO
• UDI-Device Identifier: 00885556704332
• UDI-Public: 00885556704332
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K152686
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: health professional,study,use
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/17/2020

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 Model Number: 75807210
• Device Catalogue Number: 75807210
• Device Lot Number: 18FPU0011A
• Initial Date Received by Manufacturer: 07/03/2019
• Supplement Date Received by Manufacturer: 02/11/2020
• Initial Report FDA Received Date: 11/22/2019
• Supplement Report FDA Received Date: 02/17/2020
• 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