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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US QUICKSET FLEX DR SFT QCK CPLE; HIP INSTRUMENT/TRIAL
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DEPUY ORTHOPAEDICS INC US QUICKSET FLEX DR SFT QCK CPLE; HIP INSTRUMENT/TRIAL Back to Search Results
Catalog Number 227452000
Device Problem Misconnection (1399)
Patient Problems No Consequences Or Impact To Patient (2199); No Information (3190); No Code Available (3191)
Event Date 04/17/2017
Event Type  malfunction  
Manufacturer Narrative
If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
 
Event Description
Der states that the flexible drill bit locking mechanism is not locking all the way.It was also reported that the surgeon tried to get it to work but it would not stayed locked so they got a modular drill bit to finish the case.
 
Manufacturer Narrative
If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
 
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Brand Name
QUICKSET FLEX DR SFT QCK CPLE
Type of Device
HIP INSTRUMENT/TRIAL
Manufacturer (Section D)
DEPUY ORTHOPAEDICS INC US
700 orthopaedic drive
warsaw IN 46581 0988
Manufacturer (Section G)
DEPUY ORTHOPAEDICS INC US
700 orthopaedic drive
warsaw IN 46581
Manufacturer Contact
chad gibson
700 orthopaedic drive
warsaw, IN 46581
5743725905
MDR Report Key6702551
MDR Text Key79655293
Report Number1818910-2017-20929
Device Sequence Number1
Product Code HTW
UDI-Device Identifier10603295109273
UDI-Public10603295109273
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor,health profession
Reporter Occupation Physician
Type of Report Initial,Followup
Report Date 04/17/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/11/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number227452000
Device Lot NumberAG0209
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/27/2017
Is the Reporter a Health Professional? Yes
Date Manufacturer Received04/27/2018
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured02/15/2009
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unknown
Patient Sequence Number1
Patient Age68 YR
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