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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY INTERNATIONAL LTD - 8010379 GLENOSPHERE ORIENTATION GUIDE EXTREMITY INSTRUMENTS : ALIGNMENT DEVICES

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DEPUY INTERNATIONAL LTD - 8010379 GLENOSPHERE ORIENTATION GUIDE EXTREMITY INSTRUMENTS : ALIGNMENT DEVICES Back to Search Results
Model Number 2307-95-000
Device Problems Break (1069); Naturally Worn (2988)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 01/01/2022
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 following items need replaced for wear and tear, this is the second set i am quality checking at (b)(6) that has had no rep support for a couple of years and bringing their kit to the standard it needs to be. Instruments opened for checking no patient involvement for these items. (b)(6).
 
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Brand NameGLENOSPHERE ORIENTATION GUIDE
Type of DeviceEXTREMITY INSTRUMENTS : ALIGNMENT DEVICES
Manufacturer (Section D)
DEPUY INTERNATIONAL LTD - 8010379
st. anthony's road
leeds LS11 8DT
UK LS11 8DT
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 Key13422892
MDR Text Key284881803
Report Number1818910-2022-02087
Device Sequence Number1
Product Code HTZ
Combination Product (y/n)N
Reporter Country CodeUK
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,Followup
Report Date 02/02/2022
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received02/02/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number2307-95-000
Device Catalogue Number230795000
Device Lot Number5116034
Was Device Available for Evaluation? Device Returned to Manufacturer
Is the Reporter a Health Professional? Yes
Date Manufacturer Received04/18/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured03/23/2012
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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