MAUDE Adverse Event Report: STRYKER INSTRUMENTS-KALAMAZOO ZYPHR DISPOSABLE CRANIAL PERFORATOR, LARGE 14/11MM; DRILLS, BURRS, TREPHINES & ACCESSORIES

Catalog Number 5100060001

Device Problem Particulates (1451)

Patient Problem No Patient Involvement (2645)

Event Date 02/20/2019

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 testing of the device, metal shavings were observed.It was also reported that this event did not occur during a surgical procedure, and there was no delay or adverse consequences as a result of this event.

Manufacturer Narrative

The reported event, for metal shedding debris, was not confirmed as the perforator bit was not returned for evaluation.Without the perforator bit, the root cause cannot be determined.

Event Description

It was reported that during a testing of the device, metal shavings were observed.It was also reported that this event did not occur during a surgical procedure, and there was no delay or adverse consequences as a result of this event.

• 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: 8434128
• MDR Text Key: 139249921
• Report Number: 0001811755-2019-00887
• 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: user facility
• Type of Report: Initial,Followup
• Report Date: 05/14/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/19/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/01/2021
• Device Catalogue Number: 5100060001
• Device Lot Number: 18296027
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/02/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1