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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS, INC. 1818910 PINN CAN BONE SCREW 6.5MMX15MM BONE SCREWS AND PINS : SCREWS

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DEPUY ORTHOPAEDICS, INC. 1818910 PINN CAN BONE SCREW 6.5MMX15MM BONE SCREWS AND PINS : SCREWS Back to Search Results
Catalog Number 121715500
Device Problem Difficult to Open or Remove Packaging Material
Event Date 03/09/2018
Event Type  Malfunction  
Manufacturer Narrative

If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

 
Event Description

Total hip joint replacement; (b)(6), (b)(6) hospital (b)(6) 2018. Screw was reportedly opened and the inner plastic casing was stuck to the outside packaging, therefore ripping the outer and making the screw unsterile. Another screw was opened instead and the unsterile screw passed off.

 
Manufacturer Narrative

Product complaint #: (b)(4). Investigation summary: no device associated with this report was received for examination. The information received will be retained for potential series investigations if triggered by trend analysis, post market surveillance, or other events within the quality system. Depuy considers the investigation closed. 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 NamePINN CAN BONE SCREW 6.5MMX15MM
Type of DeviceBONE SCREWS AND PINS : SCREWS
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 19380-0988
6103142063
MDR Report Key7407792
Report Number1818910-2018-56923
Device Sequence Number1
Product CodeLPH
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,FOREIG
Reporter Occupation HEALTH PROFESSIONAL
Type of Report Initial,Followup,Followup,Followup
Report Date 03/13/2018
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received04/09/2018
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device Catalogue Number121715500
Device LOT NumberPU122187
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer03/28/2018
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received03/06/2019
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured06/02/2017
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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