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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 ATTUNE 0 DEG LEFT CUT BLOCK ATTUNE INSTRUMENTS : RESECTION BLOCKS/DEVICES

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DEPUY IRELAND - 9616671 ATTUNE 0 DEG LEFT CUT BLOCK ATTUNE INSTRUMENTS : RESECTION BLOCKS/DEVICES Back to Search Results
Model Number 2544-00-014
Device Problems Material Deformation (2976); Physical Resistance/Sticking (4012)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 07/01/2020
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 holes of the block that connect to the jig are warped or pinched. The block gets stuck on the tibia jigs.
 
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Brand NameATTUNE 0 DEG LEFT CUT BLOCK
Type of DeviceATTUNE INSTRUMENTS : RESECTION BLOCKS/DEVICES
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
700 orthopaedic dr.
warsaw, IN 46581-0988
6107428552
MDR Report Key10271079
MDR Text Key198720922
Report Number1818910-2020-15781
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
Report Date 07/01/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received07/14/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number2544-00-014
Device Catalogue Number254400014
Device Lot NumberPG225456
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 Received08/11/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured06/14/2013
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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