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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 MODULAR CALCAR PLANER SML REAMERS

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DEPUY IRELAND - 9616671 MODULAR CALCAR PLANER SML REAMERS Back to Search Results
Model Number 2570-04-501
Device Problems Dull, Blunt (2407); Failure to Cut (2587); Device-Device Incompatibility (2919)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 11/18/2019
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 calcar planner shaft was not functioning properly during the case. The reamers used were also said to be dull. Need to send replacements for the shaft as well as the planners themselves. The head impactor tip was also cracked during the case. It broke into two pieces, both of which were removed. No surgical delay.
 
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Brand NameMODULAR CALCAR PLANER SML
Type of DeviceREAMERS
Manufacturer (Section D)
DEPUY IRELAND - 9616671
loughbeg ringaskiddy co.
cork
EI
Manufacturer (Section G)
DEPUY ORTHOPAEDICS, INC. 1818910
700 orthopaedic dr.
warsaw IN 46581 0988
Manufacturer Contact
kara ditty-bovard
1210 ward avenue
west chester, IN 46581-0988
6103142063
MDR Report Key9446462
MDR Text Key187854219
Report Number1818910-2019-122132
Device Sequence Number1
Product Code HTO
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 11/18/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received12/10/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number2570-04-501
Device Catalogue Number257004501
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received03/23/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
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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