MAUDE Adverse Event Report: STRYKER INSTRUMENTS-KALAMAZOO PERFORATOR BIT LARGE 14/11MM; DRILLS, BURRS, TREPHINES & ACCESSORIES

Catalog Number 5100060001

Device Problem Application Interface Becomes Non-Functional Or Program Exits Abnormally (1138)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/01/2015

Event Type  malfunction  

Manufacturer Narrative

A follow up report will be filed once the quality investigation is complete.Product disposition is unknown.

Event Description

It was reported that during a cranial procedure, the perforator bit stopped half way through when drilling the third hole.It was also reported that the surgeon believed the issue was related to the patient anatomy in that area.It was further reported that there were no adverse consequences as a result of this event and the procedure was completed using an alternative bur.

Manufacturer Narrative

The quality investigation is complete.Device not returned to manufacturer.

Event Description

It was reported that during a cranial procedure, the perforator bit stopped half way through when drilling the third hole.It was also reported that the surgeon believed the issue was related to the patient anatomy in that area.It was further reported that there were no adverse consequences as a result of this event and the procedure was completed using an alternative bur.

• Brand Name: PERFORATOR BIT LARGE 14/11MM
• Type of Device: DRILLS, BURRS, TREPHINES & ACCESSORIES
• Manufacturer (Section D): STRYKER INSTRUMENTS-KALAMAZOO; 4100 east milham avenue; kalamazoo MI 49001
• Manufacturer (Section G): STRYKER INSTRUMENTS-IRELAND; instruments division; carrigtwohill bus. & tech park; carrigtwohill NA
• Manufacturer Contact: dervillia murphy ; instruments division; carrigtwohill bus. & tech park; carrigtwohill NA ; 214532900
• MDR Report Key: 5030653
• MDR Text Key: 25034391
• Report Number: 0001811755-2015-03118
• Device Sequence Number: 1
• Product Code: HBF
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K082010
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Nurse
• Type of Report: Followup
• Report Date: 08/03/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/26/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 5100060001
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/27/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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