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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY INTERNATIONAL LTD - 8010379 HARDINGE HORIZONTAL RETRACTOR; HIP INSTRUMENTS : RETRACTORS
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DEPUY INTERNATIONAL LTD - 8010379 HARDINGE HORIZONTAL RETRACTOR; HIP INSTRUMENTS : RETRACTORS Back to Search Results
Catalog Number 963216000
Device Problem Break (1069)
Patient Problem Insufficient Information (4580)
Event Date 12/16/2020
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
The hardinge retractor got broked when they tried to bend it.
 
Manufacturer Narrative
Product complaint # (b)(4).Investigation summary: the device associated with the reported event was not returned for evaluation.Visual examination of the provided photograph confirmed the reported event.Depuy 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.Device history lot: the product investigation found no evidence suspecting an error in the manufacturing or material that would be a contributing factor in the reported allegation(s).Where the lot code was provided, a manufacturing records evaluation (mre) was not performed.
 
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Brand Name
HARDINGE HORIZONTAL RETRACTOR
Type of Device
HIP INSTRUMENTS : RETRACTORS
Manufacturer (Section D)
DEPUY INTERNATIONAL LTD - 8010379
st. anthony's road
leeds LS11 8DT
UK  LS11 8DT
MDR Report Key11123603
MDR Text Key225292485
Report Number1818910-2021-00433
Device Sequence Number1
Product Code GAD
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Type of Report Initial,Followup
Report Date 12/18/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/06/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number963216000
Device Lot Number00PN29141
Was Device Available for Evaluation? No
Date Manufacturer Received03/11/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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