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 07/02/2019

Event Type  malfunction  

Manufacturer Narrative

A follow up report will be filed once the quality investigation is complete.Awaiting return of device to manufacturer.

Event Description

It was reported that during a cranial procedure, the perforator bit did not stop spinning at the desired time.It was further reported that there were no adverse consequence for the patient or delays to surgery as a result of the reported event.It was also reported that the surgery was completed successfully.

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.

Event Description

It was reported that during a cranial procedure, the perforator bit did not stop spinning at the desired time.It was further reported that there were no adverse consequence for the patient or delays to surgery as a result of the reported event.It was also reported that the surgery 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 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.

Event Description

It was reported that during a cranial procedure, the perforator bit did not stop spinning at the desired time.It was further reported that there were no adverse consequence for the patient or delays to surgery as a result of the reported event.It was also reported that the surgery 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
• MDR Report Key: 8841793
• MDR Text Key: 152664249
• Report Number: 0001811755-2019-02603
• 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: company representative
• Type of Report: Initial,Followup,Followup
• Report Date: 12/04/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/30/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/01/2021
• Device Catalogue Number: 5100060001
• Device Lot Number: 18212037
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/05/2019
• Date Manufacturer Received: 12/04/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1