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

Catalog Number 5100060001

Device Problem Failure to Auto Stop (2938)

Patient Problem Hemostasis (1895)

Event Date 05/18/2017

Event Type  Injury  

Manufacturer Narrative

A follow up report will be filed once the quality investigation is complete.Device unavailable for return.

Event Description

It was reported that during a cranial procedure, the perforator bit did not stop.It was also reported that there was an unintentional cortical injury and increased blood loss as a result of this event.It was further reported that it is unknown at this time if a delay or medical intervention occurred as a result of this event.No further information was provided.

Manufacturer Narrative

The perforator product reported involved with this event was not returned for evaluation.A device history review(dhr) was performed and all manufacturing specifications were met during the time of manufacture of this product.Without the perforator involved with this event the reported failure of failure to disengage could not be confirmed.

Event Description

It was reported that during a cranial procedure, the perforator bit did not stop.It was also reported that there was an unintentional cortical injury and increased blood loss as a result of this event.It was further reported that it is unknown at this time if a delay or medical intervention occurred as a result of this event.No further information was provided.

• 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
• Manufacturer (Section G): STRYKER INSTRUMENTS-IRELAND; instruments division; carrigtwohill bus. & tech park; carrigtwohill NA
• Manufacturer Contact: una barry ; instruments division; carrigtwohill bus. & tech park; carrigtwohill NA ; 214532900
• MDR Report Key: 6589481
• MDR Text Key: 75900931
• Report Number: 0001811755-2017-01256
• Device Sequence Number: 1
• Product Code: HBF
• UDI-Device Identifier: 4546540716224
• UDI-Public: (01)4546540716224(17)180102(10)17039027
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K082010
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 09/11/2017

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: 02/01/2018
• Device Catalogue Number: 5100060001
• Device Lot Number: 17039027
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/19/2017
• Initial Date FDA Received: 05/24/2017
• Supplement Dates Manufacturer Received: 09/01/2017
• Supplement Dates FDA Received: 09/11/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/08/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other