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

Model Number 71631070

Device Problem Activation, Positioning or Separation Problem (2906)

Patient Problem Injury (2348)

Event Date 05/10/2020

Event Type  Injury  

Event Description

It was reported that during intertan short nail operation when medial cortex reached with screw shaft a lot of resistance was met.The trigen t handle kept disengaging from the long screw driver as multiple attempts to fully seat the screw failed.Surgeon eventually abandoned seating screw.Wounds closed.Dressings applied.The driver was isolate and send for analysis to company as feel it should not have disengaged from t handle.

Manufacturer Narrative

The device used in treatment was returned for evaluation.Visual inspection of the returned device confirms that the device has signs of wear and tear from use.Functional evaluation of the returned device confirms that the driver is worn out and is slightly curved and out of shape where it engages with t handle which might be the reason for failure.According to clinical/medical investigation, the complaint reports that a trigen t handle kept disengaging from a long hex-driver.After multiple attempts and trying other handles the surgeon chose to abandoned the seating screw and closed the wound.The impact to the patient cannot be determined with the limited information.It is unknown how much of a delay was incurred during this issue.Smith and nephew has not received adequate materials to fully evaluate the complaint, but if additional clinically relevant materials are later received, then the case may be re-opened for further evaluation.A review of the manufacturing records did not reveal any manufacturing or material abnormalities that could have caused or contributed to the reported incident.A review of complaint history for the listed part revealed no prior complaints for the part/lot combination.At this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.The device is a reusable device that can be exposed to numerous surgeries and cleaning cycles.Probable causes that could contribute to the reported event, as reusable instruments are susceptible to damage from prolonged use and through misuse or rough handling.To avoid compromised performance or damage, it is recommended the device be inspected prior to and after each use and cleaning.We recommend that all re-usable instruments be routinely inspected for wear/damage and replaced as necessary.A review of risk management files and the instructions for use found that the reported failure was documented appropriately.Based on this investigation, the need for corrective action is not indicated.Should additional information be received, the complaint will be reopened.No further actions are being taken at this time.We consider this investigation closed.Credit will be issued for the device.

• Brand Name: LONG HEXDRIVER
• Type of Device: ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• MDR Report Key: 10172089
• MDR Text Key: 195717691
• Report Number: 1020279-2020-02575
• Device Sequence Number: 1
• Product Code: HSB
• UDI-Device Identifier: 03596010519269
• UDI-Public: 03596010519269
• 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,foreig
• Type of Report: Initial,Followup
• Report Date: 05/14/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/18/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 71631070
• Device Catalogue Number: 71631070
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/10/2020
• Date Manufacturer Received: 05/14/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention