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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US QUICKSET DEPTH GAUGE 70MM HIP INSTRUMENTS : DRILL GUIDES

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DEPUY ORTHOPAEDICS INC US QUICKSET DEPTH GAUGE 70MM HIP INSTRUMENTS : DRILL GUIDES Back to Search Results
Model Number 2274-60-000
Device Problems Break (1069); Crack (1135)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 05/18/2020
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 items are cracked or broken. No surgical delay.
 
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Brand NameQUICKSET DEPTH GAUGE 70MM
Type of DeviceHIP INSTRUMENTS : DRILL GUIDES
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 Key10089822
MDR Text Key192163370
Report Number1818910-2020-12606
Device Sequence Number1
Product Code HTJ
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,Followup
Report Date 05/18/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received05/26/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number2274-60-000
Device Catalogue Number227460000
Device Lot NumberAG0900
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer05/21/2020
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received06/02/2020
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured09/15/2000
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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