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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 RECLAIM ASSEMB TOOL ADAPT 75MM; RECLAIM INSTRUMENTS : INSERTION DEVICES
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DEPUY IRELAND - 9616671 RECLAIM ASSEMB TOOL ADAPT 75MM; RECLAIM INSTRUMENTS : INSERTION DEVICES Back to Search Results
Catalog Number 297500605
Medical Device Problem Code Material Deformation (2976)
Health Effect - Clinical Code No Consequences Or Impact To Patient (2199)
Date of Event 10/30/2018
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
Product complaint # (b)(4).Investigation summary: examination of the returned instrument confirmed the complaint.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
It was reported that the instrument was found damaged in sterile processing.
 
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Brand Name
RECLAIM ASSEMB TOOL ADAPT 75MM
Common Device Name
RECLAIM INSTRUMENTS : INSERTION DEVICES
Manufacturer (Section D)
DEPUY IRELAND - 9616671
loughbeg ringaskiddy co.
cork
EI 
MDR Report Key8111348
Report Number1818910-2018-76532
Device Sequence Number16574556
Product Code LXH
UDI-Device Identifier10603295155959
UDI-Public10603295155959
Combination Product (Y/N)N
Initial Reporter StateNC
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) 11/26/2018
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 Number297500605
Device Lot NumberSO2000054
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/26/2018
Type of Report(Section G)Initial
Initial Date Received by Manufacturer 11/26/2018
Initial Report FDA Received Date11/28/2018
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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