MAUDE Adverse Event Report: STRYKER INSTRUMENTS-KALAMAZOO 180-GRAM CEMENT CARTRIDGE WITH BREAKAWAY FEMORAL NOZZLE; MIXER, CEMENT, FOR CLINICAL USE

Catalog Number	0206530000
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Extravasation (1842)
Date of Event	05/15/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Device not available for return.
Event or Problem Description
It was reported that during the procedure, the device shattered.Medical intervention to remove the cement that had already been injected was necessary.The procedure was successfully completed after obtaining a new device.No further adverse consequences were reported.
Additional Manufacturer Narrative
Correction: b2.This correction is being filed to update outcomes attributed to the adverse event.
Event or Problem Description
It was reported that during the procedure, the device shattered.Medical intervention to remove the cement that had already been injected was necessary.The procedure was successfully completed after obtaining a new device.No further adverse consequences were reported.

• Brand Name: 180-GRAM CEMENT CARTRIDGE WITH BREAKAWAY FEMORAL NOZZLE
• Common Device Name: MIXER, CEMENT, FOR CLINICAL USE
• Manufacturer (Section D): STRYKER INSTRUMENTS-KALAMAZOO; 4100 east milham avenue; kalamazoo MI 49001
• MDR Report Key: 7678910
• Report Number: 0001811755-2018-01150
• Device Sequence Number: 645737
• Product Code: JDZ
• UDI-Device Identifier: 34546540857881
• UDI-Public: 34546540857881
• Combination Product (Y/N): N
• Initial Reporter Country: AU
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 11/30/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 0206530000
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/13/2018
• Supplement Date Received by Manufacturer: 11/28/2020
• Initial Report FDA Received Date: 07/11/2018
• Supplement Report FDA Received Date: 11/30/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention