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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITH & NEPHEW, INC. INTERTAN 1.5 11.5MMX32CM 130D RT; NAIL, FIXATION, BONE
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SMITH & NEPHEW, INC. INTERTAN 1.5 11.5MMX32CM 130D RT; NAIL, FIXATION, BONE Back to Search Results
Catalog Number 71676574
Device Problem Mechanical Jam (2983)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 11/01/2018
Event Type  malfunction  
Event Description
It was reported that during surgery the intertan nail got stuck to the handle.Delay of over 2 hours reported.No injury reported.Procedure finished with competitor device.
 
Manufacturer Narrative
The associated drill guide handle and the nail were returned and evaluated.A visual inspection found that the nail is fixed on the drill guide; the devices cannot be separated.It is possible that the threads on both devices were cross threaded causing them to fail.A review of the manufacturing records for the listed batch did not reveal any deviation from the standard manufacturing processes.Our investigation did not determine a specific cause of the stated failure.We recommend that all re-usable instruments be routinely inspected for wear/damage and replaced as necessary.We consider this investigation closed.
 
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Brand Name
INTERTAN 1.5 11.5MMX32CM 130D RT
Type of Device
NAIL, FIXATION, BONE
Manufacturer (Section D)
SMITH & NEPHEW, INC.
1450 brooks road
memphis TN 38116
MDR Report Key8106036
MDR Text Key128414010
Report Number1020279-2018-02600
Device Sequence Number1
Product Code JDS
UDI-Device Identifier00885556039250
UDI-Public00885556039250
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,health
Type of Report Initial,Followup
Report Date 01/23/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/27/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date10/14/2021
Device Catalogue Number71676574
Device Lot Number11KM08454
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/08/2018
Date Manufacturer Received11/02/2018
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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