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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 ATTUNE SPACER BLOCK; ATTUNE INSTRUMENTS : SPACER BLOCKS/TRIAL SHIMS
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DEPUY IRELAND - 9616671 ATTUNE SPACER BLOCK; ATTUNE INSTRUMENTS : SPACER BLOCKS/TRIAL SHIMS Back to Search Results
Model Number 2544-01-014
Device Problem Use of Device Problem (1670)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 06/11/2021
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
Nurses reported missing balseal from attune trial and spacer block.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.Device history lot : the product investigation found no evidence suspecting an error in the manufacturing or material that would be a contributing factor in the reported allegation(s).A manufacturing records evaluation (mre) was not performed.
 
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Brand Name
ATTUNE SPACER BLOCK
Type of Device
ATTUNE INSTRUMENTS : SPACER BLOCKS/TRIAL SHIMS
Manufacturer (Section D)
DEPUY IRELAND - 9616671
loughbeg ringaskiddy co.
cork
EI 
MDR Report Key12092779
MDR Text Key259178330
Report Number1818910-2021-13939
Device Sequence Number1
Product Code HWT
UDI-Device Identifier10603295395379
UDI-Public10603295395379
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Type of Report Initial,Followup
Report Date 06/11/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/30/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number2544-01-014
Device Catalogue Number254401014
Device Lot NumberBFA0WLN
Was Device Available for Evaluation? No
Date Manufacturer Received08/03/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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