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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY IRELAND 9616671 ATTUNE FB CR ARTIC SURF SZ5; ATTUNE INSTRUMENTS : TIBIAL TRIALS
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DEPUY IRELAND 9616671 ATTUNE FB CR ARTIC SURF SZ5; ATTUNE INSTRUMENTS : TIBIAL TRIALS Back to Search Results
Catalog Number 254500525
Device Problem Break (1069)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 06/25/2018
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 spring for the fixed bearing, cruciate retaining tray trial broke off.No other information available.
 
Manufacturer Narrative
(b)(4).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 Name
ATTUNE FB CR ARTIC SURF SZ5
Type of Device
ATTUNE INSTRUMENTS : TIBIAL TRIALS
Manufacturer (Section D)
DEPUY IRELAND 9616671
loughbeg, ringaskiddy co.
cork
EI 
MDR Report Key7698603
MDR Text Key114330591
Report Number1818910-2018-64706
Device Sequence Number1
Product Code JWH
UDI-Device Identifier10603295132653
UDI-Public10603295132653
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Type of Report Initial,Followup
Report Date 06/25/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/18/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number254500525
Was Device Available for Evaluation? No
Date Manufacturer Received12/04/2018
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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