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 Abrasion (1689); Radiation Exposure, Unintended (3164)

Event Date 06/09/2017

Event Type  Injury  

Manufacturer Narrative

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

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 durotomy during a bur hole as a result of this event.It was further reported that there was no clinical adverse consequences to the patient as a result of this event.No further information on the event was provided.

Manufacturer Narrative

Additional information received that a post operative brain scan was required and the procedure was completed successfully.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.Device discarded 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 an unintentional durotomy during a bur hole as a result of this event requiring a post operative brain scan.It was further reported that there was no clinical adverse consequences to the patient as a result of this event.It was also reported that the procedure was completed successfully.

• 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: 6695309
• MDR Text Key: 79347713
• Report Number: 0001811755-2017-01367
• Device Sequence Number: 1
• Product Code: HBF
• UDI-Device Identifier: 4546540716224
• UDI-Public: (01)4546540716224
• 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: 09/22/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/07/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 5100060001
• Device Lot Number: TBD
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/22/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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