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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 ATTUNE REV CONV CUT GUIDE SZ 7 RESECTION BLOCKS/DEVICES

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DEPUY IRELAND - 9616671 ATTUNE REV CONV CUT GUIDE SZ 7 RESECTION BLOCKS/DEVICES Back to Search Results
Catalog Number 250440607
Device Problem Material Twisted/Bent (2981)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 07/24/2018
Event Type  malfunction  
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
The cutting block is bent.
 
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.
 
Manufacturer Narrative
Product complaint #: (b)(4). Investigation summary: evaluation of the returned device confirms the reported event. 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 NameATTUNE REV CONV CUT GUIDE SZ 7
Type of DeviceRESECTION BLOCKS/DEVICES
Manufacturer (Section D)
DEPUY IRELAND - 9616671
loughbeg ringaskiddy co.
cork
EI
Manufacturer (Section G)
DEPUY ORTHOPAEDICS, INC. 1818910
700 orthopaedic dr.
warsaw IN 46582 0988
Manufacturer Contact
chad gibson
700 orthopaedic dr.
warsaw, IN 46582-0988
5743725905
MDR Report Key7785028
MDR Text Key117165997
Report Number1818910-2018-66740
Device Sequence Number1
Product Code HTZ
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 07/25/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received08/15/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number250440607
Device Lot NumberABG43592
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer10/04/2018
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received10/04/2018
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured09/14/2017
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

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