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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 03/30/2021
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 " after the surgery i was informed by a person in sterile processing that there appeared to be a problem with one of the springs on the spacer block.We did not encounter a problem in surgery.The spring was taken off by the person washing the instruments and was unable to be found after it was brought to my attention".No delay to surgery.
 
Manufacturer Narrative
Product complaint # (b)(4) investigation summary examination of the returned confirmed the reported event.The investigation could not identify a root cause for the missing balseal spring without the spring component to examine.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.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).Where the lot code was provided, a manufacturing records evaluation (mre) was not performed.
 
Manufacturer Narrative
Product complaint # (b)(4).This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by depuy synthes joint reconstruction, or its employees that the report constitutes an admission that the product, depuy synthes joint reconstruction, 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 report, a follow-up report will be filed as appropriate.
 
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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 Key11633843
MDR Text Key244408293
Report Number1818910-2021-07437
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,health
Type of Report Initial,Followup,Followup
Report Date 03/30/2021
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 Number2544-01-014
Device Catalogue Number254401014
Device Lot NumberBFA0RPC
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer04/15/2021
Initial Date Manufacturer Received 03/30/2021
Initial Date FDA Received04/08/2021
Supplement Dates Manufacturer Received04/15/2021
04/29/2021
Supplement Dates FDA Received04/23/2021
05/03/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Age57 YR
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