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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 ATTUNE CR FEM TRIAL SZ 3 LT; ATTUNE INSTRUMENTS : FEMORAL TRIALS
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DEPUY IRELAND - 9616671 ATTUNE CR FEM TRIAL SZ 3 LT; ATTUNE INSTRUMENTS : FEMORAL TRIALS Back to Search Results
Model Number 2545-00-713
Device Problems Material Discolored (1170); Illegible Information (4050)
Patient Problems No Consequences Or Impact To Patient (2199); No Code Available (3191)
Event Date 01/01/2020
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 the color markings are wearing off (12 trials).
 
Manufacturer Narrative
Product complaint # (b)(4).Investigation summary : examination of the returned device could not confirm the reported event.No device defects were identified.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.
 
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Brand Name
ATTUNE CR FEM TRIAL SZ 3 LT
Type of Device
ATTUNE INSTRUMENTS : FEMORAL TRIALS
Manufacturer (Section D)
DEPUY IRELAND - 9616671
loughbeg ringaskiddy co.
cork
EI 
MDR Report Key10460834
MDR Text Key204581671
Report Number1818910-2020-18919
Device Sequence Number1
Product Code JWH
UDI-Device Identifier10603295133858
UDI-Public10603295133858
Combination Product (y/n)N
PMA/PMN Number
K140881
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Type of Report Initial,Followup
Report Date 08/19/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/27/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number2545-00-713
Device Catalogue Number254500713
Device Lot NumberMVMCLP910
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer09/01/2020
Date Manufacturer Received09/03/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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