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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US QUICKSET 1PC FLEX DRILL BIT 35; DRILLS (BITS, SLEEVES, GUIDES) : DRILLS

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DEPUY ORTHOPAEDICS INC US QUICKSET 1PC FLEX DRILL BIT 35; DRILLS (BITS, SLEEVES, GUIDES) : DRILLS Back to Search Results
Model Number 2274-35-500
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 08/25/2020
Event Type  malfunction  
Manufacturer Narrative
Product complaint # (b)(4).Investigation summary: as there was no reported failure, not confirmation of failure could occur but upon physical review of the instrument a bent condition was identified.Depuy-synthes considers the investigation closed at this time.Should additional information be received, the information will be reviewed, and the investigation will be re-opened as necessary.
 
Event Description
It was reported that the instrument was reported for unknown reason.
 
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Brand Name
QUICKSET 1PC FLEX DRILL BIT 35
Type of Device
DRILLS (BITS, SLEEVES, GUIDES) : DRILLS
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 drive
warsaw, IN 46581-0988
6107428552
MDR Report Key10682961
MDR Text Key211441400
Report Number1818910-2020-22340
Device Sequence Number1
Product Code HTW
UDI-Device Identifier10603295109174
UDI-Public10603295109174
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
Report Date 08/25/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/15/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number2274-35-500
Device Catalogue Number227435500
Device Lot NumberPG258737
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer09/03/2020
Is the Reporter a Health Professional? Yes
Date Manufacturer Received09/24/2020
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured08/23/2016
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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