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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS, INC. 1818910 MTO CHANA DUAL OFFSET RMR HDL HIP INSTRUMENTS : HANDLES

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DEPUY ORTHOPAEDICS, INC. 1818910 MTO CHANA DUAL OFFSET RMR HDL HIP INSTRUMENTS : HANDLES Back to Search Results
Catalog Number 299960038
Device Problems Break; Defective Component; Material Twisted / Bent
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. Examination of the returned instrument found the instrument to have broken and deformed material. The root cause is attributed to heavy usage and wear out. 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.

 
Event Description

It was reported that the tray pulled of the shelf and checked, item noticed to be defective. Not used in surgery.

 
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Brand NameMTO CHANA DUAL OFFSET RMR HDL
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 , PA 19380
6103142063
MDR Report Key9106523
Report Number1818910-2019-105828
Device Sequence Number1
Product CodeHTO
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,HEALTH
Type of Report Initial,Followup
Report Date 09/23/2019
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received09/23/2019
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device Catalogue Number299960038
Device LOT NumberPS0809
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer08/13/2019
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/23/2019
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured08/15/2009
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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