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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US QUICKSET ACE GRATER HEAD 56MM; HIP INSTRUMENTS : REAMERS
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DEPUY ORTHOPAEDICS INC US QUICKSET ACE GRATER HEAD 56MM; HIP INSTRUMENTS : REAMERS Back to Search Results
Model Number 2440-00-556
Device Problem Break (1069)
Patient Problem Not Applicable (3189)
Event Date 06/06/2020
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 quickset grater broke or separated while reaming from the base and shell of grater.
 
Manufacturer Narrative
Product complaint (b)(4).Investigation summary : examination of the returned instrument confirmed the complaint.Depuy-synthes 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.
 
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Brand Name
QUICKSET ACE GRATER HEAD 56MM
Type of Device
HIP INSTRUMENTS : REAMERS
Manufacturer (Section D)
DEPUY ORTHOPAEDICS INC US
700 orthopaedic drive
warsaw IN 46581 0988
MDR Report Key10298865
MDR Text Key199667811
Report Number1818910-2020-16274
Device Sequence Number1
Product Code HTO
UDI-Device Identifier10603295124030
UDI-Public10603295124030
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Type of Report Initial,Followup
Report Date 07/06/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/20/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number2440-00-556
Device Catalogue Number244000556
Device Lot NumberA0106
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer07/13/2020
Date Manufacturer Received07/22/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Weight136
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