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 Abrasion (1689)

Event Date 10/24/2018

Event Type  Injury  

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 stop.It was also reported that there was an unintentional durotomy during a bur hole and two cortical veins were also torn.It was further reported that treatment of additional bleeding was performed by bipolar coagulation forceps, surgicel and neuropatchas a result of this event.It was further reported that there were no surgical delay and the procedure was completed successfully and the patient has no neurological symptoms following this incident.

Event Description

It was reported that during a cranial procedure, the perforator bit did not stop.It was also reported that there was an unintentional durotomy during a bur hole and two cortical veins were also torn.It was further reported that treatment of additional bleeding was performed by bipolar coagulation forceps, surgicel and neuropatchas a result of this event.It was further reported that there were no surgical delay and the procedure was completed successfully and the patient has no neurological symptoms following this incident.

Manufacturer Narrative

The perforator product reported involved with this event was returned for evaluation and the disengagement mechanism within the perforator was tested and functioned as intended.The reported failure of failure to disengage could not be confirmed.The ifu #5100-060-700 rev.F provides instructions on how to test the disengagement function of the perforator prior to use.The ifu also warns: use extreme caution when drilling in conditions such as: - bone that may vary in consistency and/or thickness greater than 1 mm.- adherent dura.- high intracranial pressure.- other abnormalities in the area of penetration.The perforator may cut or nick the dura or brain.

• 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
• MDR Report Key: 8085616
• MDR Text Key: 127604695
• Report Number: 0001811755-2018-02496
• Device Sequence Number: 1
• Product Code: HBF
• UDI-Device Identifier: 04546540716224
• UDI-Public: 04546540716224
• Combination Product (y/n): N
• PMA/PMN Number: K082010
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 02/12/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/01/2021
• Device Catalogue Number: 5100060001
• Device Lot Number: 18190017
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/20/2018
• Initial Date Manufacturer Received: 10/24/2018
• Initial Date FDA Received: 11/19/2018
• Supplement Dates Manufacturer Received: 02/01/2019
• Supplement Dates FDA Received: 02/12/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: 5407300000E, SN,(B)(4); 5407300000E, SN,(B)(4)
• Patient Outcome(s): Required Intervention