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

Model Number 71360046

Device Problem Material Integrity Problem (2978)

Patient Problem No Patient Involvement (2645)

Event Date 06/02/2020

Event Type  malfunction  

Event Description

It was reported that the accord dual ended hex driver was found stripped and not working properly.No procedure-related.

Manufacturer Narrative

Corrected lot number: d4.Additional information: d4 and h4.The device, intended for use in treatment, were returned for evaluation.A visual inspection of the returned accord dual ended hex driver confirmed the stated failure.The hex driving tip is 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.This device exhibits signs of significant use and wear.This device was manufactured in 2016.A review of complaint history on the listed part revealed no prior complaints for the listed batch with the same failure mode.A review of the manufacturing records did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident.This device is a 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.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.

• Brand Name: ACCORD DUAL ENDED HEX DRIVER
• Type of Device: PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• MDR Report Key: 10199832
• MDR Text Key: 196571044
• Report Number: 1020279-2020-02779
• 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,user f
• Type of Report: Initial,Followup
• Report Date: 08/03/2020

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: 16GM09652
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/30/2020
• Initial Date Manufacturer Received: 06/02/2020
• Initial Date FDA Received: 06/26/2020
• Supplement Dates Manufacturer Received: 07/30/2020
• Supplement Dates FDA Received: 08/03/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1