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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US SUMMIT CALCAR PLANER-LARGE; HIP INSTRUMENTS : REAMERS

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DEPUY ORTHOPAEDICS INC US SUMMIT CALCAR PLANER-LARGE; HIP INSTRUMENTS : REAMERS Back to Search Results
Catalog Number 257004200
Device Problems Dull, Blunt (2407); Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 10/28/2019
Event Type  malfunction  
Manufacturer Narrative
Product complaint # (b)(4).Investigation summary
=
> examination of the returned instrument found the planer is dull.The root cause is attributed to heavy usage/ wear out.Depuy 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.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
 
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.Investigation summary: examination of the returned instrument found the planer is dull.The root cause is attributed to heavy usage/ wear out.Depuy 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 calcar planers need to be replaced.No surgical delay.
 
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Brand Name
SUMMIT CALCAR PLANER-LARGE
Type of Device
HIP INSTRUMENTS : REAMERS
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
1210 ward avenue
west chester, PA 19380-0988
6103142063
MDR Report Key9510402
MDR Text Key184388781
Report Number1818910-2019-124526
Device Sequence Number1
Product Code LYS
UDI-Device Identifier10603295143185
UDI-Public10603295143185
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
Report Date 10/28/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number257004200
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/13/2019
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 12/17/2019
Initial Date FDA Received12/23/2019
Supplement Dates Manufacturer Received12/17/2019
Supplement Dates FDA Received12/27/2019
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured08/15/2008
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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