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

Catalog Number 2101-0005

Device Problems Break (1069); Crack (1135); Fracture (1260); Split (2537); Material Integrity Problem (2978)

Patient Problems No Known Impact Or Consequence To Patient (2692); No Information (3190)

Event Date 02/11/2016

Event Type  malfunction  

Event 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.

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 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
• Type of Device: POLYMETHYLMETHACRYLATE (PMMA) BONE CEMENT
• Manufacturer (Section D): STRYKER ORTHOBIOLOGICS-MALVERN; 45 great valley parkway; malvern PA 19355
• Manufacturer (Section G): STRYKER ORTHOBIOLOGICS-MALVERN; 45 great valley parkway; malvern PA 19355
• Manufacturer Contact: christa marrow ; 2 pearl court; allendale, NJ 07401 ; 2017608000
• MDR Report Key: 5483613
• MDR Text Key: 40060310
• Report Number: 0002530131-2016-00005
• Device Sequence Number: 1
• Product Code: NDN
• UDI-Device Identifier: 00808232000962
• UDI-Public: (01)00808232000962
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 02/11/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/07/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: 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
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/11/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/23/2015
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1