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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US QUICKSET ACE GRATER HEAD 49MM; HIP INSTRUMENTS : REAMERS

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DEPUY ORTHOPAEDICS INC US QUICKSET ACE GRATER HEAD 49MM; HIP INSTRUMENTS : REAMERS Back to Search Results
Catalog Number 244000549
Device Problem Crack (1135)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 01/01/2019
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 two acetabular reamers were handed to the rep.Prior to multiple surgeries.Product code (b)(4) was cracked.No surgical delay.
 
Manufacturer Narrative
Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.Product complaint # (b)(4).Investigation summary: examination of the returned instrument confirmed the reported observation.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, a follow-up medwatch will be filed as appropriate.
 
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Brand Name
QUICKSET ACE GRATER HEAD 49MM
Type of Device
HIP INSTRUMENTS : REAMERS
Manufacturer (Section D)
DEPUY ORTHOPAEDICS INC US
700 orthopaedic drive
warsaw IN 46582 0988
MDR Report Key8504017
MDR Text Key141601268
Report Number1818910-2019-90423
Device Sequence Number1
Product Code HTO
UDI-Device Identifier10603295123965
UDI-Public10603295123965
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 04/04/2019
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 Number244000549
Device Lot NumberA0907
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer04/08/2019
Initial Date Manufacturer Received 04/04/2019
Initial Date FDA Received04/11/2019
Supplement Dates Manufacturer Received05/31/2019
Supplement Dates FDA Received05/31/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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