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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US PINN CAN BONE SCREW 6.5MMX35MM BONE SCREWS AND PINS : SCREWS

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DEPUY ORTHOPAEDICS INC US PINN CAN BONE SCREW 6.5MMX35MM BONE SCREWS AND PINS : SCREWS Back to Search Results
Catalog Number 121735500
Device Problem Difficult to Open or Remove Packaging Material
Event Date 10/29/2018
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. (b)(4).

 
Event Description

It was reported that the packaging for screws did not open correctly and compromised sterility.

 
Manufacturer Narrative

Product complaint #: (b)(4). This is a duplicate report of 1818910-2018-75813. 1818910-2018-75578. Is being retracted as it is a report duplication. 1818910-2018-75813 will be kept for investigation purposes.

 
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. This is a duplicate report of 1818910-2018-75813. (b)(4) is being retracted as it is a report duplication. 1818910-2018-75813 will be kept for investigation purposes.

 
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Brand NamePINN CAN BONE SCREW 6.5MMX35MM
Type of DeviceBONE SCREWS AND PINS : SCREWS
Manufacturer (Section D)
DEPUY ORTHOPAEDICS INC US
700 orthopaedic drive
warsaw IN 46581 0988
Manufacturer (Section G)
JJM (SUZHOU) LTD. 3006356043
no. 299, changyang street
suzhou industrial park
suzhou, jiangsu 21512 6
CH  215126
Manufacturer Contact
kara ditty-bovard
1210 ward avenue
west chester , PA 19380
6107428552
MDR Report Key8073293
Report Number1818910-2018-75578
Device Sequence Number1
Product CodeLPH
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,HEALTH
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 10/29/2018
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received11/15/2018
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device Catalogue Number121735500
Device LOT NumberD18053200
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received12/13/2018
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured08/02/2018
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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