MAUDE Adverse Event Report: STRYKER INSTRUMENTS-KALAMAZOO ZYPHR PERFORATOR BIT; DRILLS, BURRS, TREPHINES & ACCESSORIES

Catalog Number 5100060001

Device Problem Failure to Auto Stop (2938)

Patient Problem Abrasion (1689)

Event Date 10/07/2019

Event Type  Injury  

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, two perforator bits did not stop spinning at the desired time.It was also reported that there was two unintentional dural opening as a result of this event.It was further reported that an unknown delay occurred as a result of this event.It was also reported that the surgery was completed successfully.

Event Description

It was reported that during a cranial procedure, two perforator bits did not stop spinning at the desired time.It was also reported that there was two unintentional dural opening as a result of this event.It was further reported that an unknown delay occurred as a result of this event.It was also reported that the surgery was completed successfully.

Manufacturer Narrative

H6; 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.H3 other text : device discarded by customer.

• Brand Name: ZYPHR PERFORATOR BIT
• Type of Device: DRILLS, BURRS, TREPHINES & ACCESSORIES
• Manufacturer (Section D): STRYKER INSTRUMENTS-KALAMAZOO; 4100 east milham avenue; kalamazoo MI 49001
• MDR Report Key: 9256581
• MDR Text Key: 164340437
• Report Number: 0001811755-2019-03592
• 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
• Report Date: 01/16/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/30/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/01/2022
• Device Catalogue Number: 5100060001
• Device Lot Number: 19196017
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/16/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention