MAUDE Adverse Event Report: SMITH & NEPHEW, INC. CONQUEST FN 7.5X115MM P-L SCR 25MM THD; DEVICE, FIXATION, PROXIMAL FEMORAL, IMPLANT

Model Number 75807215

Device Problem Connection Problem (2900)

Patient Problem Injury (2348)

Event Date 06/10/2019

Event Type  Injury  

Event Description

It was reported that the locking plate was not screwing and the screws disengaged.This was discovered after the case.

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 it was reported that the locking plate was not screwing and the screws disengaged.This was discovered after the case.To date no medical records have been provided.Without supporting medical documentation, a thorough medical assessment cannot be performed.In the event medical/clinical records are received, the clinical task will be re-opened and a thorough assessment will be rendered at that time.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 improper insertion technique or device damaged during use.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 7.5X115MM P-L SCR 25MM THD
• Type of Device: DEVICE, FIXATION, PROXIMAL FEMORAL, IMPLANT
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 9363674
• MDR Text Key: 167643896
• Report Number: 1020279-2019-04143
• Device Sequence Number: 1
• Product Code: JDO
• UDI-Device Identifier: 00885556704349
• UDI-Public: 00885556704349
• Combination Product (y/n): N
• PMA/PMN Number: K152686
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 02/18/2020

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
• Device Operator: Health Professional
• Device Model Number: 75807215
• Device Catalogue Number: 75807215
• Device Lot Number: 18DPU0007A
• Initial Date Manufacturer Received: 06/10/2019
• Initial Date FDA Received: 11/22/2019
• Supplement Dates Manufacturer Received: 02/12/2020
• Supplement Dates FDA Received: 02/18/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention