MAUDE Adverse Event Report: STRYKER INSTRUMENTS-KALAMAZOO MIS 13CM CURVED ATTACHMENT; DRILLS, BURRS, TREPHINES & ACCESSORIES (SIMPLE, POWERED)

Catalog Number 5407120950C

Device Problem Leak/Splash (1354)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/23/2016

Event Type  malfunction  

Event Description

It was reported that during a surgical procedure at the user facility the device was leaking an unknown substance.The procedure was completed successfully.No delay, no medical intervention and no adverse consequences were reported with this event.

Manufacturer Narrative

Follow-up report submitted to document device evaluation results.

Event Description

It was reported that during a surgical procedure at the user facility, the device was leaking an unknown substance.The procedure was completed successfully.No delay, no medical intervention and no adverse consequences were reported with this event.

• Brand Name: MIS 13CM CURVED ATTACHMENT
• Type of Device: DRILLS, BURRS, TREPHINES & ACCESSORIES (SIMPLE, POWERED)
• Manufacturer (Section D): STRYKER INSTRUMENTS-KALAMAZOO; 4100 east milham avenue; kalamazoo MI 49001
• Manufacturer (Section G): STRYKER INSTRUMENTS-KALAMAZOO; 4100 east milham avenue; kalamazoo MI 49001
• Manufacturer Contact: casey metzger ; 4100 east milham avenue; kalamazoo, MI 49001 ; 2693237700
• MDR Report Key: 5586837
• MDR Text Key: 42993315
• Report Number: 0001811755-2016-00389
• Device Sequence Number: 1
• Product Code: HBE
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K143540
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 03/23/2016

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: 5407120950C
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/29/2016
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 03/23/2016
• Initial Date FDA Received: 04/19/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 05/11/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/05/2015
• 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