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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 ATTUNE REVISION TIBIAL BLOCK R RESECTION BLOCKS/DEVICES

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DEPUY IRELAND - 9616671 ATTUNE REVISION TIBIAL BLOCK R RESECTION BLOCKS/DEVICES Back to Search Results
Model Number 2506-10-112
Device Problems Device-Device Incompatibility (2919); Mechanical Jam (2983)
Patient Problems No Consequences Or Impact To Patient (2199); No Code Available (3191)
Event Date 09/03/2020
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 pin got stuck in a pin hole during the procedure and could not be removed. Had to cut both ends of the pin off and leave the rest of it stuck in the block in order to proceed. No surgical delay.
 
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Brand NameATTUNE REVISION TIBIAL BLOCK R
Type of DeviceRESECTION BLOCKS/DEVICES
Manufacturer (Section D)
DEPUY IRELAND - 9616671
loughbeg ringaskiddy co.
cork
EI
Manufacturer (Section G)
DEPUY ORTHOPAEDICS INC 1818910
700 orthopaedic drive
warsaw IN 46581 0988
Manufacturer Contact
kara ditty-bovard
700 orthopaedic dr.
warsaw, IN 46581-0988
6107428552
MDR Report Key10546835
MDR Text Key207330022
Report Number1818910-2020-20330
Device Sequence Number1
Product Code HTZ
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 09/03/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received09/17/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number2506-10-112
Device Catalogue Number250610112
Device Lot NumberSO2032244
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer09/12/2020
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/23/2020
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured03/07/2018
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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