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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SMITH & NEPHEW, INC. RALLY HV AB ALL IN ONE SYSTEM 70G EU BONE CEMENT, ANTIBIOTIC

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SMITH & NEPHEW, INC. RALLY HV AB ALL IN ONE SYSTEM 70G EU BONE CEMENT, ANTIBIOTIC Back to Search Results
Catalog Number 55600015
Device Problem Packaging Problem (3007)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 06/04/2019
Event Type  Malfunction  
Event Description

It was reported that while opening the device, the cement powder was leaking out of the device. This makes the device unsterile, and faulty. Delay not greater than 30 min. No injury reported. The procedure was completed with the competitor product.

 
Manufacturer Narrative

The associated device and packaging was not returned. A review of the manufacturing records did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident. Based on the above evaluations there is no evidence that the nonconformity was due to a defect of the product, rather it is possible that the device was broken due to a strong mechanical-shock during transportation and the powder was leaking out. Without the actual product involved and/or device information, our investigation cannot proceed. If the device or new information is received in the future, this complaint can be re-opened. No further actions are being taken at this time. We consider this investigation closed.

 
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Brand NameRALLY HV AB ALL IN ONE SYSTEM 70G EU
Type of DeviceBONE CEMENT, ANTIBIOTIC
Manufacturer (Section D)
SMITH & NEPHEW, INC.
1450 brooks road
memphis TN 38116
Manufacturer (Section G)
SMITH & NEPHEW, INC.
1450 brooks road
memphis TN 38116
Manufacturer Contact
sarah freestone
1450 brooks road
memphis, TN 38116
0447940038
MDR Report Key8787690
MDR Text Key151006230
Report Number1020279-2019-02673
Device Sequence Number1
Product Code MBB
Combination Product (Y/N)N
Reporter Country CodeSF
PMA/PMN NumberK143100
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,FOREIG
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 11/21/2019
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received07/14/2019
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator HEALTH PROFESSIONAL
Device Catalogue Number55600015
Device LOT Number16KTC0037
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 Received11/14/2019
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
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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