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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS, INC. 1818910 ATTUNE DISTAL FEMORAL JIG; KNEE INSTRUMENT/TRIAL

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DEPUY ORTHOPAEDICS, INC. 1818910 ATTUNE DISTAL FEMORAL JIG; KNEE INSTRUMENT/TRIAL Back to Search Results
Catalog Number 254400520
Device Problem Break (1069)
Patient Problem No Information (3190)
Event Date 09/14/2015
Event Type  malfunction  
Manufacturer Narrative
This complaint is still under investigation.Depuy will notify the fda of the results of this investigation once it has been completed.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.(b)(4).
 
Event Description
The end of the red capture broke off on the attune distal jig adaptor.
 
Manufacturer Narrative
This complaint is still under investigation.Depuy will notify the fda of the results of this investigation once it has been completed.
 
Manufacturer Narrative
The complaint states the end of the red capture broke off on the attune distal jig adaptor.The returned device confirmed that the trigger had broken.The complaint details the breakage of the trigger on the slide tube component of the distal femoral jig.It is not clear when this failure happened, but there is not reported patient harm recorded the complaint shall be closed with an undetermined conclusion and entered into the complaints system and monitored through trend analysis.If further information is received the complaint shall be reopened and investigated further.
 
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Brand Name
ATTUNE DISTAL FEMORAL JIG
Type of Device
KNEE INSTRUMENT/TRIAL
Manufacturer (Section D)
DEPUY ORTHOPAEDICS, INC. 1818910
700 orthopaedic drive
warsaw IN 46582
Manufacturer (Section G)
DEPUY ORTHOPAEDICS, INC. 1818910
700 orthopaedic drive
warsaw IN 46582
Manufacturer Contact
steve dowell
700 orthopaedic drive
warsaw, IN 46581
5743714918
MDR Report Key5116299
MDR Text Key27200129
Report Number1818910-2015-31860
Device Sequence Number1
Product Code LXH
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor,health profession
Reporter Occupation Physician
Type of Report Followup
Report Date 09/14/2015
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number254400520
Device Lot NumberABC90328
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer10/12/2015
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received Not provided
Initial Date FDA Received10/01/2015
Supplement Dates Manufacturer ReceivedNot provided
Supplement Dates FDA Received11/04/2015
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured09/05/2014
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unknown
Patient Sequence Number1
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