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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS, INC. 1818910  PINN CAN BONE SCREW 6.5MMX35MM BONE SCREWS AND PINS : SCREWS

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DEPUY ORTHOPAEDICS, INC. 1818910  PINN CAN BONE SCREW 6.5MMX35MM BONE SCREWS AND PINS : SCREWS Back to Search Results
Catalog Number 121735500
Device Problem Component Missing
Event Date 08/03/2018
Event Type  Malfunction  
Manufacturer Narrative

(b)(4). Additional narrative: if information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

 
Event Description

Tha corail pinnacle daa; (b)(6), (b)(6) hospital (b)(6) 2018. Opening fully sealed packaging to reveal no product inside. There was only the information booklet. There were other 35mm screws on consignment so there were no adverse consequences to the patient or procedure. (b)(6).

 
Manufacturer Narrative

Product complaint #: (b)(4). Investigation summary: no device associated with this report was received for examination. 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. 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.

 
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Brand NamePINN CAN BONE SCREW 6.5MMX35MM
Type of DeviceBONE SCREWS AND PINS : SCREWS
Manufacturer (Section D)
DEPUY ORTHOPAEDICS, INC. 1818910 
700 orthopaedic drive
warsaw IN 46582 0988
Manufacturer (Section G)
JOHNSON & JOHNSON MEDICAL (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 , IN 19380-0988
6103142063
MDR Report Key7821996
Report Number1818910-2018-67828
Device Sequence Number1
Product CodeLPH
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,FOREIG
Reporter Occupation
Type of Report Initial,Followup
Report Date 08/03/2018
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received08/28/2018
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device Catalogue Number121735500
Device LOT NumberD16101026
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 Received12/17/2018
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Date Device Manufactured03/23/2017
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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