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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.

 
Event Description

It was reported that the packaging for the screw did not open correctly compromising sterility. No surgical delay.

 
Manufacturer Narrative

Product complaint (b)(4). Investigation summary examination of the returned packed product finds it only partially opened. There is no obvious issue with the seal of the pouch. 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, a follow-up medwatch will be filed as appropriate.

 
Manufacturer Narrative

Product complaint # (b)(4). Investigation summary: examination of the returned packed product finds it only partially opened. There is no obvious issue with the seal of the pouch. 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 6.5MMX35MM
Type of DeviceBONE SCREWS AND PINS : SCREWS
Manufacturer (Section D)
DEPUY ORTHOPAEDICS INC US
700 orthopaedic drive
warsaw IN 46582 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-XXXX
6103142063
MDR Report Key8080304
Report Number1818910-2018-75813
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 Received11/16/2018
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device Catalogue Number121735500
Device LOT NumberD18053200
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer11/26/2018
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received12/04/2018
Was Device Evaluated By Manufacturer? Yes
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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