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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: TRIMED, INC WRIST HOOK DORSAL IMPACTOR
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TRIMED, INC WRIST HOOK DORSAL IMPACTOR Back to Search Results
Model Number IMPCT-WHD
Device Problems Out-Of-Box Failure (2311); Device Contamination with Chemical or Other Material (2944)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 10/27/2017
Event Type  malfunction  
Event Description
On (b)(4) 2017 a sales rep reported that two wrist hook dorsal impactor (impct-whd) were found with rust on the grip handle.The nonconforming parts were found upon opening the wrist hook set in the clinical setting.The impct-whd is enclosed in the wrist hook set, the nonconforming part was visible upon opening of the set and was never removed our touched, and the set was immediately closed back up.The entire set was immediately replaced with an entirely new set of parts and tools were used, no adverse events were reported.This is the first time that this type of malfunction has occurred for this part.
 
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Brand Name
WRIST HOOK DORSAL IMPACTOR
Type of Device
IMPACTOR
Manufacturer (Section D)
TRIMED, INC
27533 avenue hopkins
santa clarita CA 91355
Manufacturer Contact
michael capellan
27533 avenue hopkin
santa clarita, CA 91355
8006337221
MDR Report Key7119454
MDR Text Key95656874
Report Number2031009-2017-00031
Device Sequence Number1
Product Code LXH
UDI-Device Identifier00842188113666
UDI-Public00842188113666
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type other
Reporter Occupation Other
Type of Report Initial
Report Date 12/14/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/14/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator No Information
Device Model NumberIMPCT-WHD
Device Catalogue NumberIMPCT-WHD
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? No
Date Manufacturer Received10/27/2017
Was Device Evaluated by Manufacturer? Yes
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unknown
Patient Sequence Number1
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