MAUDE Adverse Event Report: STRYKER INSTRUMENTS-KALAMAZOO ZYPHR DISPOSABLE CRANIAL PERFORATOR, 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 09/12/2017

Event Type  malfunction  

Manufacturer Narrative

The device is available for return.A follow up report will be filed once the quality investigation is complete.

Event Description

It was reported that during a cranial procedure, the perforator bit did not disengage so the perforator did not stop spinning and it went through the patients skull.It was also reported that this event caused a slight medical delay to the surgery.It was further reported that there were no adverse consequence for the patient and the procedure was completed successfully.

Manufacturer Narrative

The reported event, for perforator bit failure to disengage, was not confirmed as the perforator bit was not returned for evaluation.Without the perforator bit, the root cause cannot be determined.The quality investigation is closed.

Event Description

It was reported that during a cranial procedure, the perforator bit did not disengage so the perforator did not stop spinning and it went through the patients skull.It was also reported that this event caused a slight medical delay to the surgery.It was further reported that there were no adverse consequence for the patient and the procedure was completed successfully.

• Brand Name: ZYPHR DISPOSABLE CRANIAL PERFORATOR, 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: una barry ; instruments division; carrigtwohill bus. & tech park; carrigtwohill NA ; 214532900
• MDR Report Key: 6930218
• MDR Text Key: 89494229
• Report Number: 0001811755-2017-01923
• Device Sequence Number: 1
• Product Code: HBF
• UDI-Device Identifier: 4546540716224
• UDI-Public: (01)4546540716224
• 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: Nurse
• Type of Report: Initial,Followup
• Report Date: 01/22/2018

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: 5100060001
• Device Lot Number: 17097017
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/12/2017
• Initial Date FDA Received: 10/09/2017
• Supplement Dates Manufacturer Received: 01/19/2018
• Supplement Dates FDA Received: 01/22/2018
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 04/07/2017
• 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