MAUDE Adverse Event Report: SMITH & NEPHEW, INC. CONQUEST FN SCREWDRIVER; DEVICE, FIXATION, PROXIMAL FEMORAL, IMPLANT

Catalog Number	71179215
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Information (3190)
Date of Event	08/29/2018
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the clips that hold screw on broke.
Additional Manufacturer Narrative
The conquest fn proximal screwdriver was returned and evaluated.A visual inspection revealed that the retaining clip was not returned with the extension rod and screw driver body.No damage or material deformation that would cause the device to fail was observed on the returned parts; however, use damage was observed on the knob of the screw extension rod.We recommend that all reusable instruments be routinely inspected for wear and damage so they can be replaced as necessary.A review of the manufacturing records did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident.This investigation could not verify or identify any evidence of product contribution to the reported problem.

• Brand Name: CONQUEST FN SCREWDRIVER
• Common Device Name: DEVICE, FIXATION, PROXIMAL FEMORAL, IMPLANT
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 7914049
• Report Number: 1020279-2018-01916
• Device Sequence Number: 19248751
• Product Code: JDO
• UDI-Device Identifier: 00885556683613
• UDI-Public: 00885556683613
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K152686
• 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): 09/27/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 71179215
• Device Lot Number: 17ESY0007
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 08/30/2018
• Supplement Date Received by Manufacturer: 10/20/2018
• Initial Report FDA Received Date: 09/27/2018
• Supplement Report FDA Received Date: 11/07/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1