MAUDE Adverse Event Report: STRYKER ORTHOBIOLOGICS-MALVERN CORTOSS GUN & MIXTIPS KIT; POLYMETHYLMETHACRYLATE (PMMA) BONE CEMENT

Catalog Number	2110-0039
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	08/18/2016
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the delivery gun broke.The plugger broke during the case.
Additional Manufacturer Narrative
Method: visual inspection, device history review, complaint history review, risk assessment; result: device history review indicated all devices accepted into final stock met specifications.Device visual inspection confirmed a broken black piston plunger in the cortoss gun.Complaint history review indicated there have been no other similar events for the reported lot.Visual inspection indicated the black piston plunger of the cortoss gun fractured at the end where it pushes trough the cartridge and the cartridge was noticed to be empty of cortoss material, this likely indicates that all the cortoss material was allowed to be pushed trough into the mix tip for delivery.Per the ifu; "allow the cortoss cartridge to equilibrate to room temperature (17-23c or 63-73f) prior to use.[.] if cortoss begins to set and becomes difficult to express, simply replace the mix tip on the dual chamber cartridge [.]" conclusion: the plausible root cause of the reported event is multifactorial.
Event or Problem Description
It was reported that the delivery gun broke, the plugger broke during the case.

• Brand Name: CORTOSS GUN & MIXTIPS KIT
• Common Device Name: POLYMETHYLMETHACRYLATE (PMMA) BONE CEMENT
• Manufacturer (Section D): STRYKER ORTHOBIOLOGICS-MALVERN; 45 great valley parkway; malvern PA 19355
• MDR Report Key: 5951241
• Report Number: 0002530131-2016-00014
• Device Sequence Number: 10784428
• Product Code: NDN
• UDI-Device Identifier: 00808232001372
• UDI-Public: (01)00808232001372
• Combination Product (Y/N): N
• Initial Reporter State: UT
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/18/2016

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 Expiration Date: 03/31/2019
• Device Catalogue Number: 2110-0039
• Device Lot Number: A1605026
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/04/2016
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 08/18/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/14/2016
• Supplement Report FDA Received Date: 12/09/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1