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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 Problems Use of Device Problem (1670); Detachment of Device or Device Component (2907)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 06/15/2021
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 the springs fell off of spacer block so it will not hold a shim in place.All pieces retrieved.
 
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.
 
Manufacturer Narrative
Product complaint #
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> (b)(4) investigation summary
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> examination of the returned device confirmed that two of four balseal springs were missing.It was also noted that the smaller post where the spring was missing was chipped.The investigation findings did not indicate that a broader investigation or corrective action was necessary.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
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> 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.Corrected: h3 and h6 (device code).
 
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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 Key12107036
MDR Text Key259661722
Report Number1818910-2021-14217
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 06/15/2021
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 NumberBFA0RP7
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer07/16/2021
Initial Date Manufacturer Received 06/15/2021
Initial Date FDA Received07/02/2021
Supplement Dates Manufacturer Received07/16/2021
08/06/2021
Supplement Dates FDA Received07/20/2021
08/10/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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