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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SIGN FRACTURE CARE INTERNATIONAL SIGN IM NAIL INTRAMEDULLARY FIXATION ROD

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SIGN FRACTURE CARE INTERNATIONAL SIGN IM NAIL INTRAMEDULLARY FIXATION ROD Back to Search Results
Device Problems Inadequacy of Device Shape and/or Size (1583); Improper or Incorrect Procedure or Method (2017)
Patient Problem No Code Available (3191)
Event Date 10/12/2016
Event Type  Injury  
Manufacturer Narrative
A product investigation was performed for this device. The actual device was not returned to the manufacturer for evaluation. The root cause of the revision surgery is attributed to a failure to follow instructions. The radiographic and clinical data were reviewed by a sign orthopedic surgeon. Sign fracture care international continues to monitor these events as part of our post market surveillance activities.
 
Event Description
We became aware on 11/10/2016 that a revision surgery has been done to exchange screws used in initial im nail implant surgery. User error in measurement caused the use of screws that were too long. Surgeon comments: "return for revision of screws. The original team mistakenly measured with the inner sleeve in place giving a falsely long screw length. The 50 and 55 mm screws were removed and replaced as indicted with 35, 40 x2, and 45 mm screws. ".
 
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Brand NameSIGN IM NAIL
Type of DeviceINTRAMEDULLARY FIXATION ROD
Manufacturer (Section D)
SIGN FRACTURE CARE INTERNATIONAL
451 hills street
suite b
richland WA 99354 5502
Manufacturer (Section G)
SIGN FRACTURE CARE INTERNATIONAL
451 hills street
suite b
richland WA 99354 5502
Manufacturer Contact
robert schmitt
451 hills street
suite b
richland, WA 99354-5502
5093711107
MDR Report Key6104967
MDR Text Key59973876
Report Number3034525-2016-00295
Device Sequence Number1
Product Code HSB
Combination Product (y/n)N
Reporter Country CodeKE
PMA/PMN Number
K022632
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional,u
Reporter Occupation
Type of Report Initial
Report Date 11/10/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/15/2016
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received11/10/2016
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 11/15/2016 Patient Sequence Number: 1
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