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 Problems Bone Fracture(s) (1870); Hemostasis (1895)

Event Date 03/27/2017

Event Type  Injury  

Manufacturer Narrative

The device is available for return.A follow up report will be filed once the quality investigation is complete.Awaiting device return to manufacturer.

Event Description

It was reported that during a cranial procedure, the perforator bit did not stop.It was also reported that there was a bone fracture with significant bleeding as a result of this event.The delay to the surgery is unknown at this time.It was further reported that the procedure was completed successfully.No further information was provided.

Manufacturer Narrative

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

Event Description

It was reported that during a cranial procedure, the perforator bit did not stop.It was also reported that there was a bone fracture with significant bleeding as a result of this event.The delay to the surgery is unknown at this time.It was further reported that the procedure was completed successfully.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: 6501673
• MDR Text Key: 73092581
• Report Number: 0001811755-2017-00863
• Device Sequence Number: 1
• Product Code: HBF
• UDI-Device Identifier: 4546540716224
• UDI-Public: (01)4546540716224(17)180101(10)17010017
• 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: Pharmacist
• Type of Report: Initial,Followup
• Report Date: 08/30/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/18/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/01/2018
• Device Catalogue Number: 5100060001
• Device Lot Number: 17010017
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/29/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/10/2017
• 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
• Treatment: 5400210060, S/N: UNKNOWN; 5407100000E, S/N: UNKNOWN
• Patient Outcome(s): Other