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 Problems Abrasion (1689); Contusion (1787)

Event Date 04/29/2020

Event Type  Injury  

Manufacturer Narrative

A follow up report will be filed once the quality investigation is complete.Awaiting information if device is available for return.

Event Description

It was reported that during a cranial procedure, the perforator continued to run on longer than expected.It was also reported that there was an unintentional dural opening and brain contusion as a result of this event.It was further reported that there were no post operative complications 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

H6; 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.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 continued to run on longer than expected.It was also reported that there was an unintentional dural opening and brain contusion as a result of this event.It was further reported that there were no post operative complications 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 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: 10123742
• MDR Text Key: 194151756
• Report Number: 0001811755-2020-01394
• 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: 08/17/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/05/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/01/2023
• Device Model Number: 5100060001
• Device Catalogue Number: 5100060001
• Device Lot Number: 20051027
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/19/2020
• Date Manufacturer Received: 08/07/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 79 YR