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

Catalog Number 0607687000

Device Problem Device Inoperable (1663)

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

Event Date 04/21/2014

Event Type  malfunction  

Event Description

It was reported that during a procedure the autoplex system stopped mixing before the cement was mixed completely, which caused a 30-45 minute delay in the procedure.It was reported that no additional anesthesia was required and that the procedure was completed utilizing back-up equipment.No medical intervention and no adverse consequences were reported with this event.

Manufacturer Narrative

During the evaluation of the device, the internal components disclosed that the threaded shaft did not complete the final turn of the thread; the strip feature stripped sooner than expected.The device was discarded by the manufacturer.

Event Description

It was reported that during a procedure, the autoplex system stopped mixing before the cement was mixed completely, which caused a 30-45 minute delay in the procedure.It was reported that no additional anesthesia was required and that the procedure was completed utilizing back-up equipment.No medical intervention and no adverse consequences were reported with this event.

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-PUERTO RICO; las palmas industrial park; highway #3, km 130.2; arroyo 0061 5
• Manufacturer (Section G): STRYKER INSTRUMENTS-PUERTO RICO; las palmas industrial park; highway #3, km 130.2; arroyo 0061 5
• Manufacturer Contact: casey metzger ; 4100 east milham avenue; kalamazoo, MI 49001 ; 2693237700
• MDR Report Key: 3811306
• MDR Text Key: 4413860
• Report Number: 0001811755-2014-01764
• Device Sequence Number: 1
• Product Code: NDN
• Combination Product (y/n): N
• Reporter Country Code: US
• 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: 04/21/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/15/2014
• 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: 14086012
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/20/2014
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 05/21/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/27/2014
• 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