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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITH & NEPHEW, INC. TRAUMA IMPLANT; NAIL, FIXATION, BONE

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SMITH & NEPHEW, INC. TRAUMA IMPLANT; NAIL, FIXATION, BONE Back to Search Results
Device Problem Insufficient Information (3190)
Patient Problem Injury (2348)
Event Type  Injury  
Event Description
In a scientific publication, zhang zeng 2017, "a retrospective analysis of the intertan nail and proximal femoral nail anti-rotation in the treatment of intertrochanteric fractures in elderly patients with osteoporosis: a minimum follow-up of 3 years" it was revealed that the patient presented a non-union a medical intervention was required.
 
Manufacturer Narrative
It was reported from a literature study that the patient presented a non-union and a medical intervention was required.The affected device, used in treatment, was not returned for evaluation.Therefore a product analysis could not be performed.As device information was not made available, device history record and complaint history review cannot be completed.There is no information that would suggest the device failed to meet specifications.A relationship, if any, between the device and the reported incident could not be corroborated.No medical documents were received for investigation.Therefore no medical assessment can be performed at this time.Without the return of the actual product involved and no patient medical records available, our investigation of this report is inconclusive.Based on this investigation, the need for corrective action is not indicated.Possible causes could include but are not limited to abnormal loading of limb, abnormal motion over time, patient anatomy or post-operative healing issue.No further investigation is warranted for this complaint; however smith and nephew will continue to monitor for future complaints and investigate as necessary.Should the device or additional information be received, the complaint will be reopened.We consider this investigation closed.
 
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Brand Name
TRAUMA IMPLANT
Type of Device
NAIL, FIXATION, BONE
Manufacturer (Section D)
SMITH & NEPHEW, INC.
1450 brooks road
memphis TN 38116
MDR Report Key9532419
MDR Text Key173101268
Report Number1020279-2019-04683
Device Sequence Number1
Product Code JDS
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional,l
Type of Report Initial,Followup
Report Date 04/28/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator No Information
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 12/10/2019
Initial Date FDA Received12/30/2019
Supplement Dates Manufacturer Received04/27/2020
Supplement Dates FDA Received04/28/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Hospitalization; Required Intervention;
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