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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US QUICKSET RATCHET SCDR HDL; HIP INSTRUMENTS : HANDLES
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DEPUY ORTHOPAEDICS INC US QUICKSET RATCHET SCDR HDL; HIP INSTRUMENTS : HANDLES Back to Search Results
Model Number 2274-02-000
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 06/08/2020
Event Type  malfunction  
Manufacturer Narrative
(b)(4).Investigation summary: examination of the returned instrument found the alleged complaint unconfirmed but found a different failure upon inspection of the instrument.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.
 
Event Description
The instrument was reported for unknown reason.
 
Manufacturer Narrative
Product complaint # (b)(6).Investigation summary: examination of the returned instrument found the alleged complaint unconfirmed but the ratchet control cap has broken away from the handle.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 RATCHET SCDR HDL
Type of Device
HIP INSTRUMENTS : HANDLES
Manufacturer (Section D)
DEPUY ORTHOPAEDICS INC US
700 orthopaedic drive
warsaw IN 46581 0988
MDR Report Key10298639
MDR Text Key199666649
Report Number1818910-2020-16261
Device Sequence Number1
Product Code HXX
UDI-Device Identifier10603295109020
UDI-Public10603295109020
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 Number2274-02-000
Device Catalogue Number227402000
Device Lot NumberD31AS4000
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/29/2020
Date Manufacturer Received08/03/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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