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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 ATTUNE SPACER BASE; ATTUNE INSTRUMENTS : SPACER BLOCKS/TRIAL SHIMS
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DEPUY IRELAND - 9616671 ATTUNE SPACER BASE; ATTUNE INSTRUMENTS : SPACER BLOCKS/TRIAL SHIMS Back to Search Results
Model Number 2544-01-015
Device Problem Break (1069)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 10/15/2020
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 they received broken instrument back from the field.Threads on red handle appear to be stripped and was broken.Spacer found broken when returned to office.No 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.
 
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Brand Name
ATTUNE SPACER BASE
Type of Device
ATTUNE INSTRUMENTS : SPACER BLOCKS/TRIAL SHIMS
Manufacturer (Section D)
DEPUY IRELAND - 9616671
loughbeg ringaskiddy co.
cork
EI 
MDR Report Key10742129
MDR Text Key213264294
Report Number1818910-2020-23403
Device Sequence Number1
Product Code HWT
UDI-Device Identifier10603295395386
UDI-Public10603295395386
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 10/15/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/27/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number2544-01-015
Device Catalogue Number254401015
Device Lot NumberBFA0LA1
Was Device Available for Evaluation? No
Date Manufacturer Received12/08/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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