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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY IRELAND 9616671 ATTUNE IMPACTION HANDLE; ATTUNE INSTRUMENTS : HANDLES
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DEPUY IRELAND 9616671 ATTUNE IMPACTION HANDLE; ATTUNE INSTRUMENTS : HANDLES Back to Search Results
Catalog Number 254401017
Device Problem Break (1069)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 03/29/2018
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 the size 3 to 5 attune saw capture red tab broke off and the attune impaction handle red tab also broke off.
 
Manufacturer Narrative
If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
 
Manufacturer Narrative
(b)(4).The reported event has been evaluated and will be monitored.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, a follow-up medwatch will be filed as appropriate.
 
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Brand Name
ATTUNE IMPACTION HANDLE
Type of Device
ATTUNE INSTRUMENTS : HANDLES
Manufacturer (Section D)
DEPUY IRELAND 9616671
loughbeg, ringaskiddy co.
cork
EI 
MDR Report Key7457684
MDR Text Key106405830
Report Number1818910-2018-58202
Device Sequence Number1
Product Code HWA
UDI-Device Identifier10603295423324
UDI-Public10603295423324
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,Followup
Report Date 03/29/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/25/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number254401017
Device Lot NumberNW143579
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer04/30/2018
Date Manufacturer Received10/08/2018
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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