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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITH & NEPHEW, INC. HFN DRILL GUIDE ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES

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SMITH & NEPHEW, INC. HFN DRILL GUIDE ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES Back to Search Results
Catalog Number 71700005
Device Problems Failure To Adhere Or Bond (1031); Difficult to Remove (1528); Device Damaged Prior to Use (2284)
Patient Problems Device Embedded In Tissue or Plaque (3165); No Information (3190)
Event Date 03/27/2017
Event Type  malfunction  
Manufacturer Narrative
Problem with surgeon being unable to place the distal interlocking screws has been reported under mdr 1020279-2017-00286.
 
Event Description
It was reported that the internal threads for impactor/extractor were stripped prevented surgeon from being able to remove the nail after it was inserted. Surgeon wanted to explant the nail due to previous failure to place the distal interlocking screws and when he was unable to explant the nail it was decided to leave the nail in place without the screws.
 
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Brand NameHFN DRILL GUIDE
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
markus poettker
schachenallee 29
aarau 5001
SZ   5001
MDR Report Key6511155
MDR Text Key73614334
Report Number1020279-2017-00288
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 05/26/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received04/21/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number71700005
Device Lot Number06MSP0005
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer04/19/2017
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received03/27/2017
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
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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