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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY ORTHOPAEDIC INC, 1818910 ATTUNE SPACER BASE; ATTUNE INSTRUMENTS : SPACER BLOCKS/TRIAL SHIMS

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DEPUY ORTHOPAEDIC INC, 1818910 ATTUNE SPACER BASE; ATTUNE INSTRUMENTS : SPACER BLOCKS/TRIAL SHIMS Back to Search Results
Catalog Number 254401015
Device Problem Break (1069)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 05/18/2018
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 spacer base plastic broke off in the spacer block when the tech was removing it after the case.
 
Manufacturer Narrative
Product complaint #: (b)(4).Investigation summary: 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.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 BASE
Type of Device
ATTUNE INSTRUMENTS : SPACER BLOCKS/TRIAL SHIMS
Manufacturer (Section D)
DEPUY ORTHOPAEDIC INC, 1818910
700 orthopaedic drive
warsaw 46582
Manufacturer (Section G)
DEPUY ORTHOPAEDIC INC, 1818910
700 orthopaedic drive
warsaw IN 46582
Manufacturer Contact
chad gibson
700 orthopaedic drive
warsaw, IN 46582
5743725905
MDR Report Key7596293
MDR Text Key110896144
Report Number1818910-2018-62051
Device Sequence Number1
Product Code HWT
UDI-Device Identifier10603295395386
UDI-Public10603295395386
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
NI
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 05/18/2018
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 Number254401015
Device Lot NumberBFA0P4J
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 05/18/2018
Initial Date FDA Received06/13/2018
Supplement Dates Manufacturer Received07/30/2018
Supplement Dates FDA Received08/08/2018
Date Device Manufactured08/26/2013
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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