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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 ATTUNE REV FEM BROACH M-L 40; BROACHES
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DEPUY IRELAND - 9616671 ATTUNE REV FEM BROACH M-L 40; BROACHES Back to Search Results
Model Number 2511-01-104
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Bone Fracture(s) (1870)
Event Date 01/01/2021
Event Type  Injury  
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
Distal femur fx occurred while broaching for femoral sleeve.
 
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.Device history lot: lot information not available.
 
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Brand Name
ATTUNE REV FEM BROACH M-L 40
Type of Device
BROACHES
Manufacturer (Section D)
DEPUY IRELAND - 9616671
loughbeg ringaskiddy co.
cork
EI 
MDR Report Key11438842
MDR Text Key238595511
Report Number1818910-2021-04650
Device Sequence Number1
Product Code HTQ
UDI-Device Identifier10603295437963
UDI-Public10603295437963
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 02/08/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/08/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Model Number2511-01-104
Device Catalogue Number251101104
Was Device Available for Evaluation? No
Date Manufacturer Received03/31/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
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