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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS, INC. 1818910 QUICKSET ACE GRATER HEAD 55MM; HIP INSTRUMENTS

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DEPUY ORTHOPAEDICS, INC. 1818910 QUICKSET ACE GRATER HEAD 55MM; HIP INSTRUMENTS Back to Search Results
Catalog Number 244000555
Device Problems Crack (1135); Pitted (1460); Scratched Material (3020)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 11/17/2017
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 customer states graters are cracked, pitted, and scratched beyond usable condition.Customer requesting review of acetabular graters by depuy engineers and a response letter indicating if depuy deems these products are still usable.No surgical delay.
 
Manufacturer Narrative
If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
 
Manufacturer Narrative
If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
 
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 Name
QUICKSET ACE GRATER HEAD 55MM
Type of Device
HIP INSTRUMENTS
Manufacturer (Section D)
DEPUY ORTHOPAEDICS, INC. 1818910
700 orthopaedic drive
warsaw IN 46582
Manufacturer (Section G)
DEPUY ORTHOPAEDICS, INC. 1818910
700 orthopaedic drive
warsaw IN 46582
Manufacturer Contact
chad gibson
700 orthopaedic drive
warsaw, IN 46582
5743725905
MDR Report Key7118263
MDR Text Key94975982
Report Number1818910-2017-51707
Device Sequence Number1
Product Code HTO
UDI-Device Identifier10603295124023
UDI-Public10603295124023
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation Health Professional
Type of Report Initial,Followup,Followup,Followup
Report Date 11/17/2017
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
Device Operator Health Professional
Device Catalogue Number244000555
Device Lot NumberSO2000883
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/28/2017
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 11/17/2017
Initial Date FDA Received12/14/2017
Supplement Dates Manufacturer Received12/15/2017
11/28/2017
01/24/2018
Supplement Dates FDA Received12/15/2017
12/18/2017
01/25/2018
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured09/19/2011
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage N
Patient Sequence Number1
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