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 Known Impact Or Consequence To Patient (2692)
Date of Event	04/25/2018
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that towards the end of the surgery it looked like the devices needed more force and the surgeon kept turning the drivers until it snapped off.Four drivers were broken in the same way.There was minimal delay to remove screw driver fragments from patient.Doctor verified with x rays that the devices were removed.
Additional Manufacturer Narrative
The associated devices were returned and evaluated.A visual inspection of the returned conquest fn screwdriver indicated that a portion of the hex features have fractured off.The fractured off portions of the devices were not returned.After evaluating the device and reviewing the dhf it is unclear the exact cause of failure.The modification of the subject device was evaluated and was found to have an acceptable functionality.A review of the manufacturing records did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident.We recommend that all reusable instruments be routinely inspected for wear and damage and replaced as necessary.A clinical analysis indicated no clinical information has been provided for inclusion in this investigation.All four drivers were reported broken.Based on the quality review of the dhf the exact cause of the failure is unclear.The future impact to the patient cannot be determined.No further clinical/medical assessment is warranted.No further investigation is warranted for this complaint; however we will continue to monitor for future complaints and investigate further as necessary.Should additional information be received, the complaint will be reopened.We consider this investigation closed.

• 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: 7531978
• Report Number: 1020279-2018-00988
• Device Sequence Number: 945423
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/17/2019

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 Catalogue Number: 71179215
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/10/2018
• Initial Date Received by Manufacturer: 04/25/2018
• Supplement Date Received by Manufacturer: 02/13/2019
• Initial Report FDA Received Date: 05/22/2018
• Supplement Report FDA Received Date: 02/17/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: 71179215/UNK LOT; 71179215/UNK LOT; 71179215/UNK LOT; 71179215/UNK LOT; 71179215/UNK LOT; 71179215/UNK LOT
• Outcome Attributed to Adverse Event: Other; Required Intervention