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

Model Number	2110-0039
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	10/12/2016
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that; sales rep states the delivery gun trigger broke during injection.
Additional Manufacturer Narrative
Method: visual inspection; device history review; complaint history review; risk assessment.Results: the reported event of the delivery gun trigger broke during injection was confirmed via visual inspection of returned device.Device history review indicated all devices accepted into final stock met specifications.Conclusion: the plausible root cause of the reported event cannot be determined conclusively due to insufficient information provided for review.
Event or Problem Description
It was reported that; sales rep states the delivery gun trigger broke during injection.

• 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: 6572679
• Report Number: 0002530131-2017-00006
• Device Sequence Number: 749835
• Product Code: NDN
• UDI-Device Identifier: 00808232001372
• UDI-Public: (01)00808232001372
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• 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: 2110-0039
• Device Catalogue Number: 2110-0039
• Device Lot Number: A1606026
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/01/2017
• Initial Date Received by Manufacturer: 10/12/2016
• Supplement Date Received by Manufacturer: 10/12/2016
• Initial Report FDA Received Date: 05/17/2017
• 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