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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS, INC. 1818910 RECLAIM ASSEMB TOOL ADAPT 75MM; HIP INSTRUMENT/TRIAL
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DEPUY ORTHOPAEDICS, INC. 1818910 RECLAIM ASSEMB TOOL ADAPT 75MM; HIP INSTRUMENT/TRIAL Back to Search Results
Catalog Number 297500605
Medical Device Problem Code Break (1069)
Health Effect - Clinical Code No Information (3190)
Date of Event 06/08/2017
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
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 upon inspecting the instruments prior to a case that was cancelled, it was found out that the sering on this instrument was damaged after years in use.
 
Additional Manufacturer Narrative
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.
 
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Brand Name
RECLAIM ASSEMB TOOL ADAPT 75MM
Common Device Name
HIP INSTRUMENT/TRIAL
Manufacturer (Section D)
DEPUY ORTHOPAEDICS, INC. 1818910
700 orthopaedic drive
warsaw IN 46582
MDR Report Key6771323
Report Number1818910-2017-22295
Device Sequence Number16306723
Product Code LXH
UDI-Device Identifier10603295155959
UDI-Public10603295155959
Combination Product (Y/N)N
Initial Reporter StateKY
Initial Reporter CountryUS
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source distributor,health profession
Initial Reporter Occupation Physician
Type of Report Initial,Followup
Report Date (Section B) 08/07/2017
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 NumberSO2002306
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/26/2017
Initial Date Received by Manufacturer 08/07/2017
Supplement Date Received by Manufacturer08/07/2017
Initial Report FDA Received Date08/07/2017
Supplement Report FDA Received Date08/07/2017
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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