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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 ATTUNE MOD POST SAW CAP SZ9-10; ATTUNE INSTRUMENTS : RESECTION BLOCKS/DEVICES
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DEPUY IRELAND - 9616671 ATTUNE MOD POST SAW CAP SZ9-10; ATTUNE INSTRUMENTS : RESECTION BLOCKS/DEVICES Back to Search Results
Catalog Number 254500047
Medical Device Problem Code Crack (1135)
Health Effect - Clinical Code No Consequences Or Impact To Patient (2199)
Date of Event 09/12/2018
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary: examination of the returned device finds the locking feature is broken.Depuy considers the investigation closed at this time.Should additional information be received, the information will be reviewed and the investigation will be re-opened as necessary.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
 
Event or Problem Description
Plastic is cracked.All pieces retrieved, no patient consequence.
 
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Brand Name
ATTUNE MOD POST SAW CAP SZ9-10
Common Device Name
ATTUNE INSTRUMENTS : RESECTION BLOCKS/DEVICES
Manufacturer (Section D)
DEPUY IRELAND - 9616671
loughbeg ringaskiddy co.
cork, munster
EI 
MDR Report Key7954104
Report Number1818910-2018-72070
Device Sequence Number11159306
Product Code LXH
UDI-Device Identifier10603295130543
UDI-Public10603295130543
Combination Product (Y/N)N
Initial Reporter StateNH
Initial Reporter CountryUS
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source company representative,health
Initial Reporter Occupation Physician
Type of Report Initial
Report Date (Section B) 09/24/2018
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
Operator of Device Health Professional
Device Catalogue Number254500047
Device Lot NumberPG226205
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer09/20/2018
Type of Report(Section G)Initial
Initial Date Received by Manufacturer 09/24/2018
Initial Report FDA Received Date10/10/2018
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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