MAUDE Adverse Event Report: SMITH & NEPHEW, INC. CANNULATED IMPACTOR- MED; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

Model Number 71675081

Device Problem Material Deformation (2976)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 05/06/2021

Event Type  malfunction  

Event Description

It was reported that during an internal fixation surgery, the cannulated impactor- med was cross threaded.It is unknown if there was a significant delay and the procedure was finished using a smith & nephew back up.Patient was not harmed.

Manufacturer Narrative

H6: the device, intended for use in treatment, was returned for evaluation.A visual inspection was performed and confirmed the cannulated impactor has damaged threads at the tip of the device.Burrs and gouges on the device indicate signs of excessive wear.A review of the device history records for the listed batch did not reveal any deviation from the standard manufacturing processes.At this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.A review of the complaint history for the listed part revealed no prior complaints for this batch number.This device is a reusable instrument that can be exposed to numerous surgeries; damage from repeated use can occur.Damage from prolonged use, misuse or rough handling are likely probable causes of the reported event.We recommend that all reusable instruments be routinely inspected for wear and damage and replaced as necessary.Based on this investigation, the need for corrective action is not indicated.Should additional information be received, the complaint will be reopened.No further investigation warranted for this complaint; however we will continue to monitor for future complaints and investigate as necessary.We consider this investigation closed.

• Brand Name: CANNULATED IMPACTOR- MED
• Type of Device: ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks rd.; memphis TN 38116
• MDR Report Key: 11860085
• MDR Text Key: 251837924
• Report Number: 1020279-2021-04522
• Device Sequence Number: 1
• Product Code: HSB
• UDI-Device Identifier: 03596010648600
• UDI-Public: 03596010648600
• 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,health
• Type of Report: Initial,Followup
• Report Date: 07/25/2021

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: 71675081
• Device Catalogue Number: 71675081
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/26/2021
• Initial Date Manufacturer Received: 05/06/2021
• Initial Date FDA Received: 05/20/2021
• Supplement Dates Manufacturer Received: 07/23/2021
• Supplement Dates FDA Received: 07/25/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1