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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 ATTUNE FEMORAL IMPACTOR; ATTUNE INSTRUMENTS : IMPACTORS
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DEPUY IRELAND - 9616671 ATTUNE FEMORAL IMPACTOR; ATTUNE INSTRUMENTS : IMPACTORS Back to Search Results
Catalog Number 254401006
Device Problem Break (1069)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 10/17/2018
Event Type  malfunction  
Manufacturer Narrative
Product complaint # (b)(4).Investigation summary: the investigation finds the impactor is broken.The complaint shall be closed with a justified conclusion; it will be entered into the complaint database and monitored through trend analysis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
 
Event Description
On 12/4/2015: upon evaluation of the returned device, the impactor was broken.
 
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Brand Name
ATTUNE FEMORAL IMPACTOR
Type of Device
ATTUNE INSTRUMENTS : IMPACTORS
Manufacturer (Section D)
DEPUY IRELAND - 9616671
loughbeg ringaskiddy co.
cork
EI 
Manufacturer (Section G)
DEPUY ORTHOPAEDICS, INC. 1818910
700 orthopaedic dr.
warsaw IN 46581 0988
Manufacturer Contact
kara ditty-bovard
700 orthopaedic dr.
warsaw, IN 46581-0988
6107428552
MDR Report Key8200887
MDR Text Key131585770
Report Number1818910-2018-79286
Device Sequence Number1
Product Code HWA
UDI-Device Identifier10603295130222
UDI-Public10603295130222
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 12/04/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/27/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number254401006
Device Lot NumberAU3654033
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/29/2018
Is the Reporter a Health Professional? Yes
Date Manufacturer Received12/04/2018
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured12/27/2013
Is the Device Single Use? No
Type of Device Usage Unknown
Patient Sequence Number1
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