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U.S. Department of Health and Human Services

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

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SMITH & NEPHEW, INC. CANNULATED IMPACTOR- MED; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES Back to Search Results
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.
 
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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 Key11860085
MDR Text Key251837924
Report Number1020279-2021-04522
Device Sequence Number1
Product Code HSB
UDI-Device Identifier03596010648600
UDI-Public03596010648600
Combination Product (y/n)N
PMA/PMN Number
K122170
Number of Events Reported1
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 Number71675081
Device Catalogue Number71675081
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer05/26/2021
Initial Date Manufacturer Received 05/06/2021
Initial Date FDA Received05/20/2021
Supplement Dates Manufacturer Received07/23/2021
Supplement Dates FDA Received07/25/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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