MAUDE Adverse Event Report: STRYKER INSTRUMENTS-KALAMAZOO AUTOPLEX SYSTEM WITH VERTAPLEX HV W/O NEEDLES; CEMENT, BONE, VERTEBROPLASTY

Catalog Number 0607687000

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

Patient Problem Therapeutic Effects, Unexpected (2099)

Event Date 05/07/2014

Event Type  malfunction  

Event Description

It was reported that during a procedure the handle of the autoplex was found to be very stiff and that the device was making a loud noise while turning, which caused a 30 minute delay in the procedure.The procedure was completed successfully utilizing back-up equipment.No medical intervention and no adverse consequences were reported with this event.

Event Description

It was reported that during a procedure, the handle of the autoplex was found to be very stiff and that the device was making a loud noise while turning, which caused a 30 minute delay in the procedure.The procedure was completed successfully utilizing back-up equipment.No medical intervention and no adverse consequences were reported with this event.

Manufacturer Narrative

The reported condition can be considered confirmed based on evaluation of the returned product.The injector handle presented some resistance and noise when rotated.The device was discarded by the manufacturer.

Manufacturer Narrative

A follow up report will be filed after the quality investigation has been completed.

• Brand Name: AUTOPLEX SYSTEM WITH VERTAPLEX HV W/O NEEDLES
• Type of Device: CEMENT, BONE, VERTEBROPLASTY
• Manufacturer (Section D): STRYKER INSTRUMENTS-KALAMAZOO; 4100 east milham avenue; highway #3, km 130.2; kalamazoo MI 49001 006
• Manufacturer (Section G): STRYKER INSTRUMENTS-PUERTO RICO; las palmas industrial park; highway #3, km 130.2; arroyo MI 49001 006
• Manufacturer Contact: casey metzger ; 4100 east milham avenue; kalamazoo, MI 49001 ; 2693237700
• MDR Report Key: 3863927
• MDR Text Key: 4570667
• Report Number: 0001811755-2014-02109
• Device Sequence Number: 1
• Product Code: NDN
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K091606
• 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: 05/14/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/10/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 0607687000
• Device Lot Number: 13072012
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/30/2014
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/01/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/13/2013
• 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