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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 Code Available (3191)
Event Date 12/24/2018
Event Type  malfunction  
Manufacturer Narrative
(b)(4). Evaluation of the returned device confirms the reported event. The conventional cut guide is bent through the posterior chamfer saw slot. 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. (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
Size 7 attune revision ap block was bent, closing down the posterior capture and not allowing saw blade to pass through.
 
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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 IRELAND - 9616671
loughbeg ringaskiddy co.
cork
EI
Manufacturer Contact
kara ditty-bovard
700 orthopaedic dr.
warsaw, IN 46581-0988
6107428552
MDR Report Key8264644
MDR Text Key133738410
Report Number1818910-2019-81631
Device Sequence Number1
Product Code HTZ
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
Type of Report Initial
Report Date 12/26/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received01/21/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number250440607
Device Lot NumberAB4206464
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/27/2018
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received12/26/2018
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured05/14/2018
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage Unkown

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