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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY IRELAND - 9616671 PINN CUP IMPACTOR TIP 28MM HIP INSTRUMENTS : INSERTION DEVICES

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DEPUY IRELAND - 9616671 PINN CUP IMPACTOR TIP 28MM HIP INSTRUMENTS : INSERTION DEVICES Back to Search Results
Catalog Number 221750006
Device Problem Scratched Material (3020)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 01/01/2017
Event Type  malfunction  
Manufacturer Narrative
(b)(4). 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 Description
All instruments have normal wear and need to be replaced. Patient consequence? :no. Is the information being submitted for this complaint all the details that are known/available regarding this event? : yes.
 
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.
 
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Brand NamePINN CUP IMPACTOR TIP 28MM
Type of DeviceHIP INSTRUMENTS : INSERTION DEVICES
Manufacturer (Section D)
DEPUY IRELAND - 9616671
loughbeg ringaskiddy co.
cork
EI
Manufacturer (Section G)
DEPUY ORTHOPAEDICS, INC. 1818910
700 orthopaedic dr.
warsaw IN 46582
Manufacturer Contact
chad gibson
700 orthopaedic dr.
warsaw, IN 46582
5743725905
MDR Report Key7705114
MDR Text Key114715823
Report Number1818910-2018-64844
Device Sequence Number1
Product Code KWY
Combination Product (y/n)N
Reporter Country CodeCA
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial,Followup
Report Date 06/27/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received07/19/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number221750006
Device Lot NumberHT0410
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/15/2017
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/23/2018
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured04/15/2010
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

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