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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITH & NEPHEW, INC. INTERTAN 11.5MM X 18CM 125D; NAIL, FIXATION, BONE
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SMITH & NEPHEW, INC. INTERTAN 11.5MM X 18CM 125D; NAIL, FIXATION, BONE Back to Search Results
Catalog Number 71675202
Device Problem Difficult to Insert (1316)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 01/30/2019
Event Type  malfunction  
Event Description
It was reported that during surgery the drill interfered with the nail, the distal screw could not be hold into place, resulting in using other length screw.Procedure was completed free hands.Delay from (0 - 30) minutes reported.Backup device available.No injury or impact to patient reported.
 
Manufacturer Narrative
The associated complaint device was not returned.A review of the production documentation for the corresponding products did not reveal any deviation from the standard manufacturing processes.A review of complaint history for the listed part revealed no prior complaints for the listed batch.Without the actual product involved, our investigation cannot proceed.If the device or new information is received in the future, this complaint can be re-opened.We consider this investigation closed.
 
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Brand Name
INTERTAN 11.5MM X 18CM 125D
Type of Device
NAIL, FIXATION, BONE
Manufacturer (Section D)
SMITH & NEPHEW, INC.
1450 brooks road
memphis TN 38116
MDR Report Key8364847
MDR Text Key137015561
Report Number1020279-2019-00778
Device Sequence Number1
Product Code JDS
UDI-Device Identifier03596010561053
UDI-Public03596010561053
Combination Product (y/n)N
PMA/PMN Number
K040212
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Type of Report Initial,Followup
Report Date 06/08/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/24/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number71675202
Device Lot Number18GT06637
Was Device Available for Evaluation? No
Date Manufacturer Received06/06/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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