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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS, INC. 1818910 S/C TRIAL HANDLE; HIPS INSTRUMENTS

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DEPUY ORTHOPAEDICS, INC. 1818910 S/C TRIAL HANDLE; HIPS INSTRUMENTS Back to Search Results
Catalog Number 205512000
Device Problems Device Reprocessing Problem (1091); Detachment Of Device Component (1104)
Patient Problem No Information (3190)
Event Date 02/02/2017
Event Type  malfunction  
Manufacturer Narrative
This complaint is still under investigation.Depuy will notify the fda of the results of this investigation once it has been completed.(b)(4).
 
Event Description
The mod/ end head trial inserters were unable to get completely cleaned.Bioburden is coming out of ball bearing fittings.
 
Manufacturer Narrative
Product complaint: (b)(4) investigation summary: examination of the returned instrument could not confirm the complaint.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.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 Name
S/C TRIAL HANDLE
Type of Device
HIPS INSTRUMENTS
Manufacturer (Section D)
DEPUY ORTHOPAEDICS, INC. 1818910
700 orthopaedic drive
warsaw IN 46581 0988
Manufacturer (Section G)
DEPUY ORTHOPAEDICS, INC. 1818910
700 orthopaedic drive
warsaw IN 46582
Manufacturer Contact
chad gibson
700 orthopaedic drive
warsaw, IN 46581-0988
5743725905
MDR Report Key6536949
MDR Text Key74326247
Report Number1818910-2017-17330
Device Sequence Number1
Product Code HWA
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor,health profession
Reporter Occupation Physician
Type of Report Initial,Followup
Report Date 02/02/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number205512000
Device Lot NumberPG1203
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/31/2017
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 02/02/2017
Initial Date FDA Received05/02/2017
Supplement Dates Manufacturer Received02/22/2018
Supplement Dates FDA Received02/27/2018
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured12/15/2003
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unknown
Patient Sequence Number1
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