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

Catalog Number 5100060001

Device Problem Failure to Auto Stop (2938)

Patient Problem Abrasion (1689)

Event Date 12/27/2014

Event Type  Injury  

Event Description

It was reported that during a procedure the perforator continued to drill longer than expected.The surgeon voluntarily stopped the perforator and noticed that the bone had been removed and the dura below was damaged.Patient impact is not yet known.A surgical delay of unknown length was also reported.

Manufacturer Narrative

The device is not available for return.A follow up report will be filed once the quality investigation is complete.Device discarded by the customer.

Event Description

It was reported that during a procedure the perforator continued to drill longer than expected.The surgeon voluntarily stopped the perforator and noticed that the bone had been removed and the dura below was damaged.Patient impact is not yet known.A surgical delay of unknown length was also reported.It was subsequently reported that the patient was placed on anti-seizure medication as a result of this event.

Manufacturer Narrative

The device subject to this event was not available to stryker, it was disposed.A device history review is not possible as the device identification lot number was not provided.The root cause could not be determined as conditions of use the device were not made available and the device was not returned.The quality investigation is complete.Device disposed.

Event Description

It was reported that during a procedure, the perforator continued to drill longer than expected.The surgeon voluntarily stopped the perforator and noticed that the bone had been removed and the dura below was damaged.Patient impact is not yet known.A surgical delay of unknown length was also reported.It was subsequently reported that the patient was placed on anti-seizure medication as a result of this event.

Manufacturer Narrative

Additional information, patient was placed on anti-seizure medication as a result of this event.A follow up report will be filed once the quality investigation is complete.Device discarded by the customer.

• Brand Name: PERFORATOR BIT 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: dervillia murphy ; instruments division; carrigtwohill bus. & tech park; carrigtwohill NA ; 214532900
• MDR Report Key: 4444308
• MDR Text Key: 5385494
• Report Number: 0001811755-2015-00258
• Device Sequence Number: 1
• Product Code: HBF
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K082010
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup,Followup
• Report Date: 12/29/2014

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 Catalogue Number: 5100060001
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/02/2015
• Initial Date FDA Received: 01/23/2015
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 02/11/2015; 06/17/2015
• 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
• Patient Outcome(s): Other