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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 Problem Break (1069)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 11/08/2021
Event Type  malfunction  
Event Description
During a total hip replacement the measuring part of the measuring guide broke off. Parts were retrieved and surgery was not delayed. No adverse event was observed.
 
Manufacturer Narrative
Product complaint # (b)(4). 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 NameQUICKSET DEPTH GAUGE 70MM
Type of DeviceHIP INSTRUMENTS : DRILL GUIDES
Manufacturer (Section D)
DEPUY ORTHOPAEDICS INC US
700 orthopaedic drive
warsaw IN 46581 0988
Manufacturer (Section G)
DEPUY ORTHOPAEDICS, INC. 1818910
700 orthopaedic dr.
warsaw IN 46581 0988
Manufacturer Contact
kara ditty-bovard
700 orthopaedic drive
warsaw, IN 46581-0988
6107428552
MDR Report Key12844561
MDR Text Key281019376
Report Number1818910-2021-25722
Device Sequence Number1
Product Code HTJ
Combination Product (y/n)N
Reporter Country CodeCA
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional,Company Representative
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup,Followup
Report Date 11/08/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received11/19/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number2274-60-000
Device Catalogue Number227460000
Device Lot NumberSO2022325
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/23/2021
Is the Reporter a Health Professional? Yes
Date Manufacturer Received01/27/2022
Was Device Evaluated by Manufacturer? No
Date Device Manufactured08/16/2016
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

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