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

Catalog Number 2110-0039

Device Problems Detachment Of Device Component (1104); Loose or Intermittent Connection (1371); Insufficient Flow or Under Infusion (2182)

Patient Problem Underdose (2542)

Event Date 10/23/2015

Event Type  malfunction  

Event Description

It was reported that; regional manager is reporting that during case, mix tip from cortoss gun would not lock on; and when trigger was squeezed, the tip popped off gun.R.M.States that only 1cc of cortoss was induced into patient and doesn't not believe it was enough to complete that pain management that was needed.

Manufacturer Narrative

Method: device history review; complaint history review; risk assessment; results: additional communication with the sales rep indicated when attaching the mix tip; it was not threaded properly.Per ifu; "to engage the two components after aligning the v-notches, the mix tip should be pushed in and the housing or base should be rotated clockwise until it meets its mechanical stop".Conclusion: the plausible root cause of the reported event is likely user error.

Event Description

It was reported that; regional manager is reporting that during case, mix tip from the gun would not lock on; and when trigger was squeezed, the tip popped off gun.R.M.States that only 1cc of the product was induced.Into patient and doesn't not believe it was enough to complete that pain management that was needed.

• Brand Name: CORTOSS GUN & MIXTIPS KIT
• 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: 5231379
• MDR Text Key: 31699369
• Report Number: 0002530131-2015-00019
• Device Sequence Number: 1
• Product Code: NDN
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 10/23/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/17/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Catalogue Number: 2110-0039
• Device Lot Number: A1504023
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 10/23/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/14/2015
• 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