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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 ATTUNE PS FEM TRIAL SZ 3 RT; ATTUNE INSTRUMENTS : FEMORAL TRIALS
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DEPUY IRELAND - 9616671 ATTUNE PS FEM TRIAL SZ 3 RT; ATTUNE INSTRUMENTS : FEMORAL TRIALS Back to Search Results
Model Number 2545-00-723
Device Problem Scratched Material (3020)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 12/10/2020
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 while putting instruments together they noticed the attune sz 3 femur trials were damaged (gashed).They look like they were hit with an osteotome or saw blade.They need replacement as sterile processing will no longer accept them.No further information is available.No surgical delay.
 
Manufacturer Narrative
Product complaint (b)(4) investigation summary: the device associated with this report was not returned for evaluation.The investigation could not draw any conclusions about the reported event without the device to examine.Depuy considers the investigation closed.Should additional information be received, the information will be reviewed and the investigation will be re-opened as necessary.
 
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Brand Name
ATTUNE PS FEM TRIAL SZ 3 RT
Type of Device
ATTUNE INSTRUMENTS : FEMORAL TRIALS
Manufacturer (Section D)
DEPUY IRELAND - 9616671
loughbeg ringaskiddy co.
cork
EI 
MDR Report Key11041260
MDR Text Key245044808
Report Number1818910-2020-27281
Device Sequence Number1
Product Code HWT
UDI-Device Identifier10603295133957
UDI-Public10603295133957
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 12/10/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/18/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number2545-00-723
Device Catalogue Number254500723
Device Lot NumberMVMBTN380
Was Device Available for Evaluation? No
Date Manufacturer Received01/26/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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