MAUDE Adverse Event Report: SMITH & NEPHEW, INC. ACCORD DUAL ENDED HEX DRIVER; PROSTHESIS,HIP,SEMI-CONSTRAINED,METAL/POLY,CEMENT

Model Number 71360046

Device Problem Material Deformation (2976)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/26/2020

Event Type  malfunction  

Event Description

It was reported that after procedure, the device was noticed to be stripped.Procedure was concluded with the same devices and no injury or delay was reported.

Manufacturer Narrative

Results of investigation: the devices, intended use in treatment, was returned for evaluation.A visual inspection of the returned accord dual ended hex drivers confirmed the stated failure.The hex driving tips are rounded and deformed.A hex can strip if the torque applied to the driver exceeds the material strength or if the hex is not seated within the screw when torque is applied.These devices exhibit signs of significant use and wear.These devices were manufactured in 2015 and 2017.A complaint history review found related failures; this failure mode will be monitored for future complaints for any necessary corrective actions.A review of the manufacturing records did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident.These devices are reusable instruments that can be exposed to numerous surgeries; damage from repeated use can occur.Expected wear/tear is likely the probable cause of the reported event.We recommend that all reusable instruments be routinely inspected for wear and damage and replaced as necessary.At this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.Based on this investigation, the need for corrective action is not indicated.Should additional information be received, the complaints will be reopened.No further investigation is warranted for these complaints; however we will continue to monitor for future complaints and investigate as necessary.We consider this investigation closed.

• Brand Name: ACCORD DUAL ENDED HEX DRIVER
• Type of Device: PROSTHESIS,HIP,SEMI-CONSTRAINED,METAL/POLY,CEMENT
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• MDR Report Key: 10564286
• MDR Text Key: 207882126
• Report Number: 1020279-2020-04763
• Device Sequence Number: 1
• Product Code: JDI
• UDI-Device Identifier: 03596010611543
• UDI-Public: 03596010611543
• Combination Product (y/n): N
• PMA/PMN Number: K123598
• 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: 10/09/2020

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
• Device Operator: Health Professional
• Device Model Number: 71360046
• Device Catalogue Number: 71360046
• Device Lot Number: 17FM06278
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/21/2020
• Initial Date Manufacturer Received: 08/26/2020
• Initial Date FDA Received: 09/21/2020
• Supplement Dates Manufacturer Received: 10/05/2020
• Supplement Dates FDA Received: 10/09/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1