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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US UNK INSERTION DEVICE
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DEPUY ORTHOPAEDICS INC US UNK INSERTION DEVICE Back to Search Results
Catalog Number UNK INSERTION DEVICE
Device Problems Device-Device Incompatibility (2919); Scratched Material (3020)
Patient Problem No Code Available (3191)
Event Date 07/09/2020
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
The neptune cup introducer is damaged.After impacting the cup into the acetabulum, on releasing the locking mechanism the blue winder would not unscrew the handle from the cup.A mullwrench was used on the shaft of the cup introducer to try and disengage the cup, which ended up leaving teeth marks in the shaft.This will need to be replaced.They had to pull out the cup to disengage the cup from the handle.Then they used the straight pinnacle handle to reinsert the cup.10 minutes' delay in the surgery.The patient ended with a good outcome.No ae reported.
 
Manufacturer Narrative
Product complaint # (b)(4).Investigation summary no device associated with this report was received for examination.A worldwide lot specific complaint database search, or manufacturing record evaluation, was not possible as the required lot number was not provided.The information received will be retained for trend analysis, post market surveillance, or other events within the quality system.
 
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Brand Name
UNK INSERTION DEVICE
Type of Device
INSERTION DEVICE
Manufacturer (Section D)
DEPUY ORTHOPAEDICS INC US
700 orthopaedic drive
warsaw IN 46581 0988
MDR Report Key10302408
MDR Text Key200855941
Report Number1818910-2020-16395
Device Sequence Number1
Product Code FZX
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 07/09/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/21/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue NumberUNK INSERTION DEVICE
Was Device Available for Evaluation? No
Date Manufacturer Received08/06/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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