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

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.

• Brand Name: RALLY HV AB ALL IN ONE SYSTEM 70G EU
• Type of Device: BONE CEMENT, ANTIBIOTIC
• Manufacturer (Section D): SMITH & NEPHEW, INC.; 1450 brooks road; memphis TN 38116
• MDR Report Key: 8787690
• MDR Text Key: 151006230
• Report Number: 1020279-2019-02673
• Device Sequence Number: 1
• Product Code: MBB
• Combination Product (y/n): N
• PMA/PMN Number: K143100
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 11/21/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 55600015
• Device Lot Number: 16KTC0037
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 07/09/2019
• Initial Date FDA Received: 07/14/2019
• Supplement Dates Manufacturer Received: 07/09/2019; 11/14/2019
• Supplement Dates FDA Received: 09/23/2019; 11/21/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1