MAUDE Adverse Event Report: STRYKER INSTRUMENTS-KALAMAZOO FOOTED ATTACHMENT 16MM; DRILLS, BURRS, TREPHINES & ACCESSORIES (SIMPLE, POWERED)

Catalog Number 5407FA2000

Device Problem Bent (1059)

Patient Problem No Patient Involvement (2645)

Event Date 08/04/2015

Event Type  malfunction  

Manufacturer Narrative

Device not yet returned for evaluation.

Event Description

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

Manufacturer Narrative

Follow up being submitted for investigation results and additional information.

Event Description

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

• Brand Name: FOOTED ATTACHMENT 16MM
• 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: 5043862
• MDR Text Key: 24658579
• Report Number: 0001811755-2015-03170
• 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: company representative
• Reporter Occupation: Other
• Type of Report: Followup
• Report Date: 09/05/2017

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: 5407FA2000
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/29/2015
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/31/2015
• Supplement Dates Manufacturer Received: 11/03/2015
• Supplement Dates FDA Received: 09/05/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/25/2015
• 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