MAUDE Adverse Event Report: STRYKER INSTRUMENTS-KALAMAZOO FOOTED ATTACHMENT 12MM; DRILLS, BURRS, TREPHINES & ACCESSORIES (SIMPLE, POWERED)

Catalog Number 5407FA1000

Device Problems Bent (1059); Overheating of Device (1437)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/25/2016

Event Type  malfunction  

Event Description

It was reported that during a surgical procedure the footed attachment was found to be bent, which can cause damage to the dura.The procedure was completed successfully without a clinically significant delay; no adverse consequences or medical intervention were reported.Upon receipt to the manufacturer the device was found to be overheating in testing.No patient involvement, no delay, no medical intervention and no adverse consequences were reported with this event.

• Brand Name: FOOTED ATTACHMENT 12MM
• 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: 5523502
• MDR Text Key: 41069801
• Report Number: 0001811755-2016-00327
• Device Sequence Number: 1
• Product Code: HBE
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K143399
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 02/25/2016

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: 5407FA1000
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/08/2016
• Initial Date Manufacturer Received: 02/25/2016
• Initial Date FDA Received: 03/24/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/23/2015
• 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