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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US UNK RESECTION BLOCK

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DEPUY ORTHOPAEDICS INC US UNK RESECTION BLOCK Back to Search Results
Catalog Number UNK RESECTION BLOCK
Device Problem Device-Device Incompatibility (2919)
Patient Problems No Consequences Or Impact To Patient (2199); No Code Available (3191)
Event Date 11/09/2020
Event Type  malfunction  
Manufacturer Narrative
(b)(4). If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
 
Event Description
It was reported that the sz 4 cut block was pinched on chamfer slots. Needs to be replaced. No surgical delay.
 
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Brand NameUNK RESECTION BLOCK
Type of DeviceRESECTION BLOCK
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 0988
Manufacturer Contact
kara ditty-bovard
700 orthopaedic dr.
warsaw, IN 46581-0988
6107428552
MDR Report Key10875425
MDR Text Key218516897
Report Number1818910-2020-25102
Device Sequence Number1
Product Code HTZ
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 11/09/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received11/20/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue NumberUNK RESECTION BLOCK
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 Received12/10/2020
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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