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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US EZCLEAN REAM HAND ZIM-HALL FIT; OTHER PRODUCTS

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DEPUY ORTHOPAEDICS INC US EZCLEAN REAM HAND ZIM-HALL FIT; OTHER PRODUCTS Back to Search Results
Catalog Number MPF310029
Device Problem Crack (1135)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 10/08/2018
Event Type  malfunction  
Manufacturer Narrative
(b)(4).Investigation summary: no devices were received.Depuy synthes considers the investigation closed at this time.Should additional information be received, the information will be reviewed and the investigation may be re-opened as necessary.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
 
Event Description
Not linked to an operative cases: cssd at (b)(6) hospital brought it to the orthopaedic technician's attention: there is a crack in the plastic covering of one of the delta motion reamer handles.There was a large split in the plastic t-handle when it returned from the cssd department.This was not noticed in theatre and to our knowledge there was no impact on any patients.
 
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Brand Name
EZCLEAN REAM HAND ZIM-HALL FIT
Type of Device
OTHER PRODUCTS
Manufacturer (Section D)
DEPUY ORTHOPAEDICS INC US
700 orthopaedic drive
warsaw IN 46581 0988
Manufacturer (Section G)
DEPUY ORTHOPAEDICS, INC. 1818910
700 orthopaedic dr.
warsaw IN 46581
Manufacturer Contact
kara ditty-bovard
700 orthopaedic drive
warsaw, IN 46581
6107428552
MDR Report Key8490815
MDR Text Key141905203
Report Number1818910-2019-90002
Device Sequence Number1
Product Code HTO
Combination Product (y/n)N
Reporter Country CodeAS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,other,user facility
Reporter Occupation Other
Type of Report Initial
Report Date 03/25/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/08/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue NumberMPF310029
Was Device Available for Evaluation? No
Date Manufacturer Received03/25/2019
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 Unknown
Patient Sequence Number1
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