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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS, INC. 1818910 S-ROM*FRAME,TRIANGLE MILLER HIP INSTRUMENTS : HANDLES

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DEPUY ORTHOPAEDICS, INC. 1818910 S-ROM*FRAME,TRIANGLE MILLER HIP INSTRUMENTS : HANDLES Back to Search Results
Catalog Number 540030
Device Problems Break; Device-Device Incompatibility; Physical Resistance/Sticking
Event Date 05/07/2019
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 srom sleeve was stuck. No surgical delay.

 
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Type of DeviceHIP INSTRUMENTS : HANDLES
Manufacturer (Section D)
DEPUY ORTHOPAEDICS, INC. 1818910
700 orthopaedic drive
warsaw IN 46582 0988
Manufacturer (Section G)
DEPUY ORTHOPAEDICS, INC. 1818910
700 orthopaedic drive
warsaw IN 46582 0988
Manufacturer Contact
kara ditty-bovard
1210 ward avenue
west chester , IN 19380-0988
6103142063
MDR Report Key8636976
Report Number1818910-2019-94461
Device Sequence Number1
Product CodeHTO
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,HEALTH
Reporter Occupation OTHER HEALTH CARE PROFESSIONAL
Type of Report Initial,Followup
Report Date 05/08/2019
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received05/23/2019
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device Catalogue Number540030
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer05/20/2019
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/03/2019
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured09/15/2003
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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