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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 ATTUNE FB PS ARTIC SURF SZ6; ATTUNE INSTRUMENTS : TIBIAL TRIALS

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DEPUY IRELAND - 9616671 ATTUNE FB PS ARTIC SURF SZ6; ATTUNE INSTRUMENTS : TIBIAL TRIALS Back to Search Results
Model Number 2545-00-506
Device Problems Component Missing (2306); Device-Device Incompatibility (2919)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 09/15/2020
Event Type  malfunction  
Manufacturer Narrative
Product complaint #: (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 spring on the back of the articulating surface are missing and won¿t snap on to a poly trial.No surgical delay.
 
Manufacturer Narrative
Product complaint #
=
> (b)(4).Investigation summary
=
> examination of the returned device confirmed the balseal spring is missing.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 FB PS ARTIC SURF SZ6
Type of Device
ATTUNE INSTRUMENTS : TIBIAL TRIALS
Manufacturer (Section D)
DEPUY IRELAND - 9616671
loughbeg ringaskiddy co.
cork
EI 
MDR Report Key10606672
MDR Text Key209174569
Report Number1818910-2020-21224
Device Sequence Number1
Product Code HWT
UDI-Device Identifier10603295132462
UDI-Public10603295132462
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 09/15/2020
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 Model Number2545-00-506
Device Catalogue Number254500506
Device Lot NumberMVMGGH380
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer09/29/2020
Initial Date Manufacturer Received 09/15/2020
Initial Date FDA Received09/30/2020
Supplement Dates Manufacturer Received10/06/2020
Supplement Dates FDA Received10/06/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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