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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY IRELAND 9616671 ATTUNE DISTAL FEM CUT BLOCK ATTUNE INSTRUMENTS : RESECTION BLOCKS/DEVICES

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DEPUY IRELAND 9616671 ATTUNE DISTAL FEM CUT BLOCK ATTUNE INSTRUMENTS : RESECTION BLOCKS/DEVICES Back to Search Results
Catalog Number 254400522
Device Problems Mechanical Jam (2983); Physical Resistance/Sticking (4012)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 02/12/2019
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 disposable pin (p/n: 254400111) was caught and stopped in the distal femur cut block (p/n: 254400522) and broken when the surgeon inserted the disposable pin with the reamer through the distal femur cut block for cutting the distal end of femur during the tka surgery on (b)(6) 2019. The surgery was completed and there was no adverse consequence to the patient. There were no broken parts in the patient¿s body. No further information is available.
 
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Brand NameATTUNE DISTAL FEM 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 drive
warsaw IN 46582 0988
Manufacturer Contact
kara ditty-bovard
1210 ward avenue
west chester, PA 19380-0988
6103142063
MDR Report Key8358431
MDR Text Key136766618
Report Number1818910-2019-85395
Device Sequence Number1
Product Code HTZ
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup,Followup,Followup
Report Date 02/12/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received02/21/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number254400522
Device Lot NumberABC29330
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/18/2019
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received04/23/2019
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured10/06/2016
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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