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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 ATTUNE FB PS ARTIC SURF SZ4; ATTUNE INSTRUMENTS : TIBIAL TRIALS
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DEPUY IRELAND - 9616671 ATTUNE FB PS ARTIC SURF SZ4; ATTUNE INSTRUMENTS : TIBIAL TRIALS Back to Search Results
Model Number 2545-00-504
Device Problem Break (1069)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 11/09/2020
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 an attune fb ps artic surf sz4 was broken during trialing.
 
Manufacturer Narrative
Product complaint # (b)(4).Investigation summary: the device associated with this report was not returned, thus the reported event could not be confirmed.The investigation could not verify or identify any product contribution to the reported event with the information provided.Depuy synthes considers the investigation closed at this time.Should additional information be received, the information will be reviewed and the investigation may be re-opened as necessary.
 
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Brand Name
ATTUNE FB PS ARTIC SURF SZ4
Type of Device
ATTUNE INSTRUMENTS : TIBIAL TRIALS
Manufacturer (Section D)
DEPUY IRELAND - 9616671
loughbeg ringaskiddy co.
cork
EI 
MDR Report Key10864601
MDR Text Key217135627
Report Number1818910-2020-24977
Device Sequence Number1
Product Code HWT
UDI-Device Identifier10603295132448
UDI-Public10603295132448
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 11/09/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/18/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number2545-00-504
Device Catalogue Number254500504
Was Device Available for Evaluation? No
Date Manufacturer Received11/20/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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