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U.S. Department of Health and Human Services

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

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SMITH & NEPHEW, INC. SHORT HEXDRIVER ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES Back to Search Results
Catalog Number 71631068
Device Problems Break (1069); Detachment Of Device Component (1104); Fracture (1260)
Patient Problems Foreign Body In Patient (2687); Device Embedded In Tissue or Plaque (3165)
Event Date 02/15/2017
Event Type  Injury  
Event Description
It was reported that a piece of the device was left in the patient when the internal thread coupling rod broke at tip in the head of the screw. Surgeon elected to leave the tip in the screw and thus in the patient since there was no way to remove the screw with the tip locked in its head.
 
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Brand NameSHORT HEXDRIVER
Type of DeviceROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
Manufacturer (Section D)
SMITH & NEPHEW, INC.
1450 brooks road
memphis TN 38116
Manufacturer (Section G)
SMITH & NEPHEW, INC.
1450 brooks road
memphis TN 38116
Manufacturer Contact
claudia de santis
schachenallee 29
aarau 5001
SZ   5001
0628320660
MDR Report Key6394774
MDR Text Key69606564
Report Number1020279-2017-00170
Device Sequence Number1
Product Code HSB
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K122170
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation
Type of Report Initial,Followup
Report Date 04/28/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received03/10/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Catalogue Number71631068
Device Lot Number09GM00616
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/01/2017
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received02/15/2017
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured07/01/2009
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

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