MAUDE Adverse Event Report: STRYKER ORTHOBIOLOGICS-MALVERN 5CC CARTRIDGE; POLYMETHYLMETHACRYLATE (PMMA) BONE CEMENT

Catalog Number	2101-0005
Medical Device Problem Codes	Break (1069); Fracture (1260); Material Integrity Problem (2978)
Health Effect - Clinical Codes	No Known Impact Or Consequence To Patient (2692); No Information (3190)
Date of Event	02/11/2016
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the implant cartridge was inserted into gun and the cartridge split and cracked when the tech was attempting to fill the cement cannula.
Additional Manufacturer Narrative
Method: visual inspection; device history review; complaint history review; risk assessment; results: visual inspection indicated cortoss cartridge fractured at the proximal end this likely indicates an excessive force was applied through the delivery gun during application.Storage and room temperature, time allow for cortoss to equilibrate to room temperature, time and technique used to dispense the cortoss and/or the force used during application could be contributing factors for the reported event.Conclusion: the likely root cause is multifactorial.
Event or Problem Description
It was reported that the implant cartridge was inserted into gun and the cartridge split and cracked when the tech was attempting to fill the cement cannula.

• Brand Name: 5CC CARTRIDGE
• Common Device Name: POLYMETHYLMETHACRYLATE (PMMA) BONE CEMENT
• Manufacturer (Section D): STRYKER ORTHOBIOLOGICS-MALVERN; 45 great valley parkway; malvern PA 19355
• MDR Report Key: 5483613
• Report Number: 0002530131-2016-00005
• Device Sequence Number: 332026
• Product Code: NDN
• UDI-Device Identifier: 00808232000962
• UDI-Public: (01)00808232000962
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/11/2016

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
• Operator of Device: No Information
• Device Catalogue Number: 2101-0005
• Device Lot Number: A1502033
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/19/2016
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 02/11/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/07/2016
• Supplement Report FDA Received Date: 06/21/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1