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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
Model Number 2544-00-522
Device Problem Device-Device Incompatibility (2919)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 11/16/2020
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 an unknown drill pin won't go through the holes of an attune distal femoral cutting block. There was no surgical delay reported.
 
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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 dr.
warsaw IN 46581 0988
Manufacturer Contact
kara ditty-bovard
700 orthopaedic dr.
warsaw, IN 46581-0988
6107428552
MDR Report Key11002492
MDR Text Key221244260
Report Number1818910-2020-26838
Device Sequence Number1
Product Code HTZ
UDI-Device Identifier10603295423737
UDI-Public10603295423737
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 11/16/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received12/14/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number2544-00-522
Device Catalogue Number254400522
Device Lot NumberABB44623
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/03/2020
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received01/04/2021
Was Device Evaluated by Manufacturer? No
Date Device Manufactured06/24/2013
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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