MAUDE Adverse Event Report: STRYKER INSTRUMENTS-PUERTO RICO AUTOPLEX SYSTEM W/O VERTAPLEX W/O NEEDLES; MIXER, CEMENT, FOR CLINICAL USE

Catalog Number 0605887000

Device Problem Appropriate Term/Code Not Available (3191)

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

Event Date 11/14/2013

Event Type  malfunction  

Event Description

It was reported that during preparation for a vertebroplasty procedure at the user facility, the entire contents of the cement spilled out of the autoples system w/o vertaplex w/o needles.A back-up device was not available and a 4 day delay in surgery was reported.No medical intervention was reported with this event.

Event Description

It was reported that during preparation for a vertebroplasty procedure at the user facility, the entire contents of the cement spilled out of the autoples system w/o vertaplex w/o needles.A back-up device was not available and a 4 day delay in surgery was reported.No medical intervention was reported with this event.

Manufacturer Narrative

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

Manufacturer Narrative

The reported cement leakage condition can be considered confirmed, based on evaluation of the returned unit.Hardened cement could be observed through the lid and mix chamber, and over the o-ring seal.The locking tabs from the mix chamber could be seen through the lid openings, which mean that the lid was not fully rotated / locked.Probable contributing factors for this condition can be associated, but not limited to: 1.Lid not properly locked on the mixing chamber or o-ring gets caught when locking the lid (most likely root cause).The locking tabs from the mix chamber could be seen thru the lid openings, which mean that the lid was not fully rotated / locked.2.Improper design of the mating tabs of the mixing chamber and lid.3.Improper design between lid, o-ring and mixing chamber allows cement to leak through during mixing/transfer.The device was discarded by the manufacturer.

• Brand Name: AUTOPLEX SYSTEM W/O VERTAPLEX W/O NEEDLES
• Type of Device: MIXER, CEMENT, FOR CLINICAL USE
• 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 MI 49001 006
• Manufacturer Contact: casey metzger ; 4100 east milham avenue; kalamazoo, MI 49001 ; 2693237700
• MDR Report Key: 3554753
• MDR Text Key: 4046789
• Report Number: 0001811755-2014-00033
• Device Sequence Number: 1
• Product Code: JDZ
• Combination Product (y/n): N
• Reporter Country Code: PL
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 12/11/2013

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: Health Professional
• Device Catalogue Number: 0605887000
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/23/2014
• Initial Date FDA Received: 01/06/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 02/05/2014
• 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
• Treatment: VERTAPLEX SPINE CEMENT TWIN (B)(4)