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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS, INC. 1818910 DLC DEPTH GAUGE HIP INSTRUMENTS : DRILL GUIDES

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DEPUY ORTHOPAEDICS, INC. 1818910 DLC DEPTH GAUGE HIP INSTRUMENTS : DRILL GUIDES Back to Search Results
Catalog Number 227436000
Device Problems Break (1069); Material Twisted/Bent (2981)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 07/31/2019
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
It was reported that the depth gauge was broken when tray was opened at the beginning of case. No surgical delay.
 
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Brand NameDLC DEPTH GAUGE
Type of DeviceHIP INSTRUMENTS : DRILL GUIDES
Manufacturer (Section D)
DEPUY ORTHOPAEDICS, INC. 1818910
700 orthopaedic drive
warsaw IN 46582 0988
Manufacturer (Section G)
DEPUY ORTHOPAEDICS, INC. 1818910
700 orthopaedic drive
warsaw IN 46582 0988
Manufacturer Contact
kara bovard
1210 ward avenue
west chester, PA 19380-0988
6103142063
MDR Report Key8915287
MDR Text Key164252491
Report Number1818910-2019-101809
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,Followup
Report Date 07/31/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received08/21/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number227436000
Device Lot NumberAG0207
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer08/21/2019
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/24/2019
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured02/15/2007
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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