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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS, INC. 1818910 ATTUNE SPACER BLOCK; KNEE INSTRUMENT/TRIAL

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DEPUY ORTHOPAEDICS, INC. 1818910 ATTUNE SPACER BLOCK; KNEE INSTRUMENT/TRIAL Back to Search Results
Catalog Number 254401014
Event Date 07/13/2017
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 while putting away an attune instrument tray and performing an examination, he noticed a spring missing from an attune spacer block handle and he pulled the handle from the set & will return.
 
Manufacturer Narrative
It was reported that while putting away an attune instrument tray and performing an examination, he noticed a spring missing from an attune spacer block handle and he pulled the handle from the set & will return.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 will be filed as appropriate.
 
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Brand Name
ATTUNE SPACER BLOCK
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
chad gibson
700 orthopaedic drive
warsaw, IN 46581
5743725905
MDR Report Key6787488
MDR Text Key82474449
Report Number1818910-2017-22625
Device Sequence Number1
Product Code HWT
UDI-Device Identifier10603295395379
UDI-Public10603295395379
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 Health Professional
Type of Report Initial,Followup
Report Date 07/13/2017
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 Number254401014
Device Lot NumberBFA0L9N
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer07/19/2017
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 07/13/2017
Initial Date FDA Received08/11/2017
Supplement Dates Manufacturer Received08/15/2017
Supplement Dates FDA Received08/31/2017
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured05/24/2013
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Patient Sequence Number1
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