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

Catalog Number 5100060001

Device Problem Failure to Auto Stop (2938)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/23/2015

Event Type  malfunction  

Manufacturer Narrative

Awaiting device evaluation.A follow up report will be filed once the quality investigation is complete.

Event Description

It was reported that during a cranial procedure, when using the perforator bit to go through a patient's skull, the "clutch" did not kick in when it finished going through the bone and the drill did not stop automatically.It was also reported that the surgeon noticed it did not stop and then stopped the drill manually.It was also reported that there was no adverse consequences as a result of this event.It was further reported that there was a couple minutes delay to get a replacement device and the procedure was completed successfully.

Manufacturer Narrative

It was initially reported that the device was returned, only the device packaging was received from the customer.The quality investigation is complete.

Event Description

It was reported that during a cranial procedure, when using the perforator bit to go through a patient¿s skull, the ¿clutch¿ did not kick in when it finished going through the bone and the drill did not stop automatically.It was also reported that the surgeon noticed it did not stop and then stopped the drill manually.It was also reported that there was no adverse consequences as a result of this event.It was further reported that there was a couple minutes delay to get a replacement device and the procedure was completed successfully.

• 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 ; 4100 east milham avenue; carrigtwohill bus. & tech park; kalamazoo, MI 49001 ; 2693237700
• MDR Report Key: 5238385
• MDR Text Key: 31671365
• Report Number: 0001811755-2015-04226
• Device Sequence Number: 1
• Product Code: HBF
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K082010
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 10/27/2015

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 Expiration Date: 08/01/2016
• Device Catalogue Number: 5100060001
• Device Lot Number: 15225027
• Was Device Available for Evaluation?: No
• Date Returned to Manufacturer: 11/12/2015
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/27/2015
• Initial Date FDA Received: 11/20/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 02/04/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/13/2015
• 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