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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US DELTAXTEND BROACH HANDLE EXTREMITY INSTRUMENTS : HANDLES

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DEPUY ORTHOPAEDICS INC US DELTAXTEND BROACH HANDLE EXTREMITY INSTRUMENTS : HANDLES Back to Search Results
Model Number 2307-01-030
Device Problem Device-Device Incompatibility (2919)
Patient Problem Insufficient Information (4580)
Event Date 07/30/2021
Event Type  malfunction  
Manufacturer Narrative
Product complaint # (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
During global anatomic tsr it was discovered that the size 48 glenoid trial had a large crack through it. Furthermore the trial stem introducer failed to engage with the neck components despite attempts to manipulate it during and after the case.
 
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Brand NameDELTAXTEND BROACH HANDLE
Type of DeviceEXTREMITY INSTRUMENTS : HANDLES
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 Key12348312
MDR Text Key267465005
Report Number1818910-2021-18259
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 company representative,foreig
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 07/30/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received08/20/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number2307-01-030
Device Catalogue Number230701030
Device Lot Number5259085
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 Received09/22/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured10/09/2015
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

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