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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US QUICKSET DEPTH GAUGE 70MM; HIP INSTRUMENTS : DRILL GUIDES

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DEPUY ORTHOPAEDICS INC US QUICKSET DEPTH GAUGE 70MM; HIP INSTRUMENTS : DRILL GUIDES Back to Search Results
Model Number 2274-60-000
Device Problems Break (1069); Illegible Information (4050)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 11/16/2020
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
Upon cleaning through decontamination the depth gague was broken at the junction point.The lot number is unable to read.
 
Manufacturer Narrative
Product complaint # (b)(4).Investigation summary: the device associated with this report was not returned.The investigation could not verify or identify any product contribution to the reported event with the information provided.Depuy synthes considers the investigation closed at this time.Should additional information be received, the information will be reviewed and the investigation may be re-opened as necessary.
 
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Brand Name
QUICKSET DEPTH GAUGE 70MM
Type of Device
HIP INSTRUMENTS : DRILL GUIDES
Manufacturer (Section D)
DEPUY ORTHOPAEDICS INC US
700 orthopaedic drive
warsaw IN 46581 0988
MDR Report Key10944946
MDR Text Key219498865
Report Number1818910-2020-26151
Device Sequence Number1
Product Code HTJ
UDI-Device Identifier10603295109358
UDI-Public10603295109358
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,Followup
Report Date 11/16/2020
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 Model Number2274-60-000
Device Catalogue Number227460000
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 11/16/2020
Initial Date FDA Received12/04/2020
Supplement Dates Manufacturer Received01/13/2021
01/14/2021
Supplement Dates FDA Received01/13/2021
01/15/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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