MAUDE Adverse Event Report: STRYKER INSTRUMENTS-KALAMAZOO DUAL SPEED CEMENT INJECTION GUN; MIXER, CEMENT, FOR CLINICAL USE

Catalog Number 0206600000

Device Problem Disassembly (1168)

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

Event Date 08/19/2013

Event Type  malfunction  

Event Description

It was reported that during a femoral neck osteotomy an unknown cement gun broke.

Event Description

It was reported that during a femoral neck osteotomy, an unknown cement gun broke.

Event Description

It was reported that during a femoral neck osteotomy, an unknown cement gun broke.

Manufacturer Narrative

Please note, the adverse event was reported on mdr (b)(4).A follow up report will be filed after the quality investigation has been completed.

Manufacturer Narrative

Corrected from "unknown" to "advanced cement mixing bowl 0306553000 (unknown).".

Manufacturer Narrative

Updated from unknown to dual speed cement injection gun (b)(4).

Event Description

It was reported that during a femoral neck osteotomy an unknown cement gun broke.

Manufacturer Narrative

Updated to indicate that the product will not be returned from the user facility the device will not be returned; it is not possible to determine the cause of the reported malfunction without an evaluation of the device.The product will not be returned from the user facility.

• Brand Name: DUAL SPEED CEMENT INJECTION GUN
• Type of Device: MIXER, CEMENT, FOR CLINICAL USE
• Manufacturer (Section D): STRYKER INSTRUMENTS-KALAMAZOO; 4100 east milham avenue; highway #3, km 130.2; kalamazoo MI 49001 006
• Manufacturer (Section G): STRYKER INSTRUMENTS-KALAMAZOO; 4100 east milham avenue; highway #3, km 130.2; kalamazoo MI 49001 006
• Manufacturer Contact: casey metzger ; 4100 east milham avenue; kalamazoo, MI 49001 ; 2693237700
• MDR Report Key: 3815964
• MDR Text Key: 4452074
• Report Number: 0001811755-2014-01789
• Device Sequence Number: 1
• Product Code: JDZ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 03/27/2014

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: Other
• Device Catalogue Number: 0206600000
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/17/2014
• Initial Date FDA Received: 05/16/2014
• Supplement Dates Manufacturer Received: Not provided; Not provided; Not provided
• Supplement Dates FDA Received: 07/03/2014; 07/07/2014; 07/18/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Treatment: ADVANCED CEMENT MIXING BOWL (B)(4) (UNKNOWN); UNKNOWN MIXING BOWL