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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITH & NEPHEW, INC. LONG HEXDRIVER ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

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SMITH & NEPHEW, INC. LONG HEXDRIVER ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES Back to Search Results
Catalog Number 71631070
Device Problem Material Discolored (1170)
Patient Problem No Code Available (3191)
Event Date 09/12/2018
Event Type  malfunction  
Event Description
It was reported that at the beginning of the surgery, when the sales representative and nurse checked the instruments, they found stains (appeared to look like blood) on the driver. They feared contamination and retrieved another driver from a second instrument set. The procedure was completed but there was a surgical delay of approximately 1 hour.
 
Manufacturer Narrative
The associated complaint device was not returned. A review of complaint history did not reveal additional complaints for the listed batch. A review of the manufacturing records did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident. The clinical/medical investigation concluded that no patient harm or injury was sustained as a result of this device related incident. Aside from a surgical delay, the procedure was completed with a backup device. No further medical assessment is warranted based on the information provided. Without the actual product involved and/or device information, our investigation cannot proceed. If the device or new information is received in the future, this complaint can be re-opened. No further actions are being taken at this time. We consider this investigation closed.
 
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Brand NameLONG HEXDRIVER
Type of DeviceROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
Manufacturer (Section D)
SMITH & NEPHEW, INC.
1450 brooks rd.
memphis TN 38116
MDR Report Key7936070
MDR Text Key122855611
Report Number1020279-2018-01963
Device Sequence Number1
Product Code HSB
Combination Product (y/n)N
PMA/PMN Number
K122170
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,user facility
Type of Report Initial,Followup
Report Date 11/30/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/04/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number71631070
Device Lot Number18AM18167
Was Device Available for Evaluation? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/12/2018
Is This a Reprocessed and Reused Single-Use Device? No

Patient Treatment Data
Date Received: 10/04/2018 Patient Sequence Number: 1
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