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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY INT'L LTD. 8010379 SCREW DEPTH GAUGE EXTREMITY INSTRUMENTS : DEPTH GAUGE

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DEPUY INT'L LTD. 8010379 SCREW DEPTH GAUGE EXTREMITY INSTRUMENTS : DEPTH GAUGE Back to Search Results
Model Number 2307-91-001
Device Problem Material Deformation (2976)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 12/02/2021
Event Type  malfunction  
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.
 
Event Description
It was reported that the tip of the depth gauge had been bent due to repeated use and is about to break.
 
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Brand NameSCREW DEPTH GAUGE
Type of DeviceEXTREMITY INSTRUMENTS : DEPTH GAUGE
Manufacturer (Section D)
DEPUY INT'L LTD. 8010379
st anthonys road
leeds LS11 8 DT
UK LS11 8 DT
Manufacturer (Section G)
DEPUY INT'L LTD. 8010379
st anthonys road
leeds LS11 8 DT
UK LS11 8 DT
Manufacturer Contact
kara ditty-bovard
700 orthopaedic dr.
warsaw, IN 46581-0988
6107428552
MDR Report Key13003791
MDR Text Key282302503
Report Number1818910-2021-27904
Device Sequence Number1
Product Code HTJ
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 12/14/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received12/14/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number2307-91-001
Device Catalogue Number230791001
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received12/28/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
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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