MAUDE Adverse Event Report: STRYKER ORTHOBIOLOGICS-MALVERN 5CC CARTRIDGE; CEMENT DISPENSER

Model Number	2101-0005
Medical Device Problem Codes	Fracture (1260); Material Integrity Problem (2978)
Health Effect - Clinical Codes	No Known Impact Or Consequence To Patient (2692); No Information (3190)
Date of Event	04/05/2017
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that; when the gun was used to squeeze the cement out of the cartridge, the cartridge broke off of the gun at the base and the tip shot forward off of the sterile field.
Additional Manufacturer Narrative
Method: visual inspection; material analysis; device history review; complaint history review; risk assessment.Results: materials analysis performed.Device history review indicated all devices accepted into final stock met specifications.Conclusion: therefore; based on this information and the material analysis the plausible root cause is misalignment of the cartridge to the gun and the tube of the cartridge then fractured because of the applied force of the rams.
Event or Problem Description
It was reported that; when the gun was used to squeeze the cement out of the cartridge, the cartridge broke off of the gun at the base and the tip shot forward off of the sterile field.

• Brand Name: 5CC CARTRIDGE
• Common Device Name: CEMENT DISPENSER
• Manufacturer (Section D): STRYKER ORTHOBIOLOGICS-MALVERN; 45 great valley parkway; malvern PA 19355
• MDR Report Key: 6537600
• Report Number: 0002530131-2017-00005
• Device Sequence Number: 10916507
• Product Code: KIH
• UDI-Device Identifier: 00808232000962
• UDI-Public: (01)00808232000962
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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): 08/23/2017

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 Model Number: 2101-0005
• Device Catalogue Number: 2101-0005
• Device Lot Number: A1610004
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/25/2017
• Initial Date Received by Manufacturer: 04/05/2017
• Supplement Date Received by Manufacturer: 04/05/2017
• Initial Report FDA Received Date: 05/02/2017
• Supplement Report FDA Received Date: 08/23/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1