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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY IRELAND 961610  ATTUNE RP PS ARTIC SURF SZ6; ATTUNE INSTRUMENTS : TIBIAL TRIALS
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DEPUY IRELAND 961610  ATTUNE RP PS ARTIC SURF SZ6; ATTUNE INSTRUMENTS : TIBIAL TRIALS Back to Search Results
Catalog Number 254500546
Device Problem Break (1069)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 05/08/2018
Event Type  malfunction  
Manufacturer Narrative
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 upon inspection, central sterile staff noticed a small piece of the attune articulating surface was broken off.
 
Manufacturer Narrative
(b)(4).The instrument associated with this report was not returned.Depuy considers the investigation closed at this time.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 will be filed as appropriate.
 
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Brand Name
ATTUNE RP PS ARTIC SURF SZ6
Type of Device
ATTUNE INSTRUMENTS : TIBIAL TRIALS
Manufacturer (Section D)
DEPUY IRELAND 961610 
loughbeg ringaskiddy
cork
EI 
MDR Report Key7560267
MDR Text Key109761561
Report Number1818910-2018-61098
Device Sequence Number1
Product Code JWH
UDI-Device Identifier10603295132868
UDI-Public10603295132868
Combination Product (y/n)N
PMA/PMN Number
K140881
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Type of Report Initial,Followup
Report Date 05/08/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/01/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number254500546
Device Lot NumberMVMBWQ420
Was Device Available for Evaluation? No
Date Manufacturer Received11/13/2018
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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