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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
Catalog Number 250610112
Device Problem Mechanical Jam (2983)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 09/04/2018
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 attune threaded pin got stuck in attune revision tibial cutting guide. The 5 minutes surgical delay.
 
Manufacturer Narrative
Product complaint #: (b)(4). Investigation summary: the device associated with this report was not returned for evaluation. The investigation could not draw any conclusions about the reported event without the device to examine. Depuy considers the investigation closed. Should additional information be received, the information will be reviewed and the investigation will be re-opened as necessary. If information is obtained that was not available for the initial medwatch, a follow-up medwatch, a follow-up medwatch will be filed as appropriate.
 
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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 46582
Manufacturer Contact
chad gibson
700 orthopaedic drive
warsaw, IN 46582
5743725905
MDR Report Key7909529
MDR Text Key121718341
Report Number1818910-2018-70495
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
Type of Report Initial,Followup
Report Date 09/04/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received09/26/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number250610112
Device Lot NumberSO2027071
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 Received10/26/2018
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured06/02/2017
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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