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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US SROM MILLER SHELL SZ 25 HIP INSTRUMENTS : INSERTION DEVICES

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DEPUY ORTHOPAEDICS INC US SROM MILLER SHELL SZ 25 HIP INSTRUMENTS : INSERTION DEVICES Back to Search Results
Model Number 2576-05-025
Device Problem Illegible Information
Event Date 02/06/2020
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. Investigation summary: examination of the returned instrument confirmed the complaint. Depuy-synthes 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 srom instruments are difficult or impossible to read the sizing. Surgeon is concerned this is a patient safety issue and instruments should be replaced. No surgical delay.

 
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Brand NameSROM MILLER SHELL SZ 25
Type of DeviceHIP INSTRUMENTS : INSERTION DEVICES
Manufacturer (Section D)
DEPUY ORTHOPAEDICS INC US
700 orthopaedic drive
warsaw IN 46581 0988
Manufacturer (Section G)
DEPUY ORTHOPAEDICS, INC. 1818910
700 orthopaedic dr.
warsaw IN 46581 0988
Manufacturer Contact
kara ditty-bovard
700 orthopaedic drive
warsaw , IN 46581-0988
6107428552
MDR Report Key9875121
Report Number1818910-2020-09147
Device Sequence Number1
Product CodeHTO
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,HEALTH
Reporter Occupation OTHER HEALTH CARE PROFESSIONAL
Type of Report Initial
Report Date 02/06/2020
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received03/24/2020
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device MODEL Number2576-05-025
Device Catalogue Number257605025
Device LOT NumberAB1005
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer02/13/2020
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received03/09/2020
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured10/15/2005
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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