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 12/31/2020

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, 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 as provided.

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 as provided.

Manufacturer Narrative

H6: the quality investigation is complete.

• 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: 11224487
• MDR Text Key: 241236866
• Report Number: 0001811755-2021-00383
• 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: 03/11/2021

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: 10/01/2023
• Device Model Number: 5100060001
• Device Catalogue Number: 5100060001
• Device Lot Number: 20275027
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/28/2021
• Initial Date Manufacturer Received: 01/05/2021
• Initial Date FDA Received: 01/25/2021
• Supplement Dates Manufacturer Received: 03/05/2021
• Supplement Dates FDA Received: 03/11/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention