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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: HAND BIOMECHANICS LAB, INC. DIGIT WIDGET
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HAND BIOMECHANICS LAB, INC. DIGIT WIDGET Back to Search Results
Model Number DWD-232
Device Problems Device Contamination With Biological Material (2908); Patient Device Interaction Problem (4001)
Patient Problem Bacterial Infection (1735)
Event Type  Injury  
Manufacturer Narrative
Reviewed sterilization and sterile barrier inspection records for probable lot.No pattern related to irradiation dose lot or device lot was noted.Confirmed labeling included cautions regarding pin site care.
 
Event Description
Patient had surgery to install the digit widget external fixation system.Physician reported, "patient developed pin tract infection and required early removal of device, is on humira for pa and immunosuppressed." device removed after 8 weeks of treatment.
 
Event Description
Patient had surgery to install the digit widget external fixation system.Physician reported, "patient developed pin tract infection and required early removal of device, is on humira for pa and immunosuppressed." device removed after 8 weeks of treatment.
 
Manufacturer Narrative
Reviewed sterilization and sterile barrier inspection records for probable lot.No pattern related to irradiation dose lot or device lot was noted.Confirmed labeling included cautions regarding pin site care.
 
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Brand Name
DIGIT WIDGET
Type of Device
DIGIT WIDGET
Manufacturer (Section D)
HAND BIOMECHANICS LAB, INC.
77 scripps drive, suite 104
sacramento CA 95825
MDR Report Key7654928
MDR Text Key112884248
Report Number2919128-2018-00023
Device Sequence Number1
Product Code JDW
UDI-Device Identifier00861994000212
UDI-Public(01)00861994000212(10)DWD-117-047B
Combination Product (y/n)N
PMA/PMN Number
K992970
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional
Type of Report Initial,Followup
Report Date 12/28/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/02/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Model NumberDWD-232
Device Catalogue NumberDWD-232
Device Lot NumberDWD-117-047B
Was Device Available for Evaluation? No
Was the Report Sent to FDA? No
Date Manufacturer Received06/11/2018
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
Patient Age25 YR
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