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

Model Number 5100060001

Device Problem Failure to Auto Stop (2938)

Patient Problem Abrasion (1689)

Event Date 11/12/2020

Event Type  Injury  

Manufacturer Narrative

A follow up report will be filed once the quality investigation is complete.Device discarded by customer.

Event Description

It was reported that during a cranial procedure, the perforator bit did not stop spinning at the desired time.It was also reported that there was an unintentional dural opening as a result of this event.No further information was provided.

Manufacturer Narrative

H6; the reported event, for 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 also reported that there was an unintentional dural opening as a result of this event.No further information was provided.

• 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: 10951250
• MDR Text Key: 219879883
• Report Number: 0001811755-2020-03349
• 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: 02/12/2021

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: 07/13/2023
• Device Model Number: 5100060001
• Device Catalogue Number: 5100060001
• Device Lot Number: 20195017
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 11/12/2020
• Initial Date FDA Received: 12/05/2020
• Supplement Dates Manufacturer Received: 01/29/2021
• Supplement Dates FDA Received: 02/12/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 42 YR