MAUDE Adverse Event Report: STRYKER ORTHOBIOLOGICS-MALVERN CORTOSS DELIVERY GUN

Catalog Number 2110-0008

Device Problems Device Inoperable (1663); Noise, Audible (3273)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 07/17/2014

Event Type  malfunction  

Event Description

It was reported that during use of the cortoss delivery gun a "popping" sound was observed.As a result the cortoss delivery gun no longer functioned and required a patient.There was no reported delay in surgical procedure or adverse consequence to the patient.

Manufacturer Narrative

Device evaluation is anticipated upon receipt from customer.

Manufacturer Narrative

Update august 15, 2014 - an evaluation was performed on the cortoss delivery gun.There was no evidence of a popping sound nor an inability to use the gun.It was observed the sliding mechanism was slightly misaligned to due force implemented by the user.Once adjusted, the device functioned as intended.There was no evidence of a device malfunction or failure.

Event Description

It was reported that during use of the cortoss delivery gun a "popping" sound was observed.As a result the cortoss delivery gun no longer functioned and required a patient.There was no reported delay in surgical procedure or adverse consequence to the patient.

• Brand Name: CORTOSS DELIVERY GUN
• Type of Device: CORTOSS DELIVERY GUN
• 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: jeremy apelian ; 45 great valley parkway; malvern, PA 19355 ; 6104075257
• MDR Report Key: 3973632
• MDR Text Key: 15910001
• Report Number: 0002530131-2014-00014
• Device Sequence Number: 1
• Product Code: NDN
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K080108
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 07/24/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/01/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 2110-0008
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/24/2014
• Was Device Evaluated by Manufacturer?: Yes
• 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