MAUDE Adverse Event Report: STRYKER INSTRUMENTS-PUERTO RICO 10G 15MM (15/2) IVAS SYSTEM KIT; CEMENT, BONE, VERTEBROPLASTY

Catalog Number 0705115000

Device Problem Break (1069)

Patient Problem Therapeutic Effects, Unexpected (2099)

Event Date 09/15/2015

Event Type  malfunction  

Manufacturer Narrative

Device discarded by customer.

Event Description

It was reported that during a procedure, the ivas system kit hub broke off of the access cannula.The procedure was delayed by an hour to try and retrieve the cannula, which resulted in the cannula being cut off to the patients bone and left there.Additional anesthesia was needed to complete the case.

• Brand Name: 10G 15MM (15/2) IVAS SYSTEM KIT
• Type of Device: CEMENT, BONE, VERTEBROPLASTY
• Manufacturer (Section D): STRYKER INSTRUMENTS-PUERTO RICO; las palmas industrial park; highway #3, km 130.2; arroyo
• Manufacturer (Section G): STRYKER INSTRUMENTS-PUERTO RICO; las palmas industrial park; highway #3, km 130.2; arroyo
• Manufacturer Contact: casey metzger ; 4100 east milham avenue; kalamazoo, MI 49001 ; 2693237700
• MDR Report Key: 5150553
• MDR Text Key: 28302338
• Report Number: 0001811755-2015-03771
• Device Sequence Number: 1
• Product Code: NDN
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K130430
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Other
• Report Date: 09/15/2015

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
• Device Operator: No Information
• Device Catalogue Number: 0705115000
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/14/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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