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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 ATTUNE ADJ TIB STYLUS; ATTUNE INSTRUMENTS : ALIGNMENT DEVICES
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DEPUY IRELAND - 9616671 ATTUNE ADJ TIB STYLUS; ATTUNE INSTRUMENTS : ALIGNMENT DEVICES Back to Search Results
Catalog Number 254400007
Device Problems Break (1069); Material Discolored (1170)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 03/08/2019
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
It was reported that while putting away instrument sets today, i found some was broken instruments.
 
Manufacturer Narrative
Product complaint (b)(4).Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.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 ADJ TIB STYLUS
Type of Device
ATTUNE INSTRUMENTS : ALIGNMENT DEVICES
Manufacturer (Section D)
DEPUY IRELAND - 9616671
loughbeg ringaskiddy co.
cork
EI 
MDR Report Key8457902
MDR Text Key140118879
Report Number1818910-2019-88693
Device Sequence Number1
Product Code HWT
UDI-Device Identifier10603295129790
UDI-Public10603295129790
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Type of Report Initial,Followup
Report Date 03/08/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/27/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number254400007
Device Lot NumberNW103655
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/26/2019
Date Manufacturer Received04/12/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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