MAUDE Adverse Event Report: SMITH & NEPHEW, INC. MEDIUM HEXDRIVER; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Model Number 71631066

Device Problem Connection Problem (2900)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/05/2020

Event Type  Injury  

Event Description

It was reported that, during surgery, the medium hexdriver was not connecting to t-handles the way it should.The procedure was finished using smith and nephew back up devices, with no surgical delay and no injury to the patient.

Manufacturer Narrative

The device, used in treatment, was returned for evaluation.A visual inspection confirms the medium hex driver is damaged on both ends of the device causing the stated failure.The hex driver shaft was not returned for evaluation.This instrument shows significant signs of use and wear.A review of complaint history did not reveal additional complaints for the listed batch for 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.A review of the risk management file revealed this failure mode was previously identified.This device is a reusable instrument 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.No further investigation is warranted for this complaint; however we will continue to monitor for future complaints and investigate as necessary.Should additional information be received, the complaint will be reopened.We consider this investigation closed.

• Brand Name: MEDIUM HEXDRIVER
• Type of Device: ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• MDR Report Key: 10451583
• MDR Text Key: 204331827
• Report Number: 1020279-2020-04202
• Device Sequence Number: 1
• Product Code: HSB
• UDI-Device Identifier: 03596010478443
• UDI-Public: 03596010478443
• Combination Product (y/n): N
• PMA/PMN Number: K122170
• 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: 05/11/2021

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: 71631066
• Device Catalogue Number: 71631066
• Device Lot Number: 12CM08158
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 08/05/2020
• Initial Date FDA Received: 08/25/2020
• Supplement Dates Manufacturer Received: 04/29/2021
• Supplement Dates FDA Received: 05/11/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1