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

Catalog Number 5100060001

Device Problems Use of Device Problem (1670); Failure to Auto Stop (2938); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Abrasion (1689)

Event Date 07/19/2016

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 surgeon was using a perforator to make 2 burr holes to raise a cranial flap for microvascular decompression.It was also reported that the perforator bit failed to stop once through the cranium and punctured the dura and grazed the cerebellum.It was also reported that surgery was completed successfully with minor time delays.

Manufacturer Narrative

The device was returned for evaluation and functional testing of the disengagement mechanism confirmed that the mechanism functioned as intended.Lot number information has not been provided to permit further investigation on manufacturing records.The definitive root cause could not be determined and potentially failure to follow instructions caused or contributed to this event.

Event Description

It was reported that during a cranial procedure, the surgeon was using a perforator to make 2 burr holes to raise a cranial flap for microvascular decompression.It was also reported that the perforator bit failed to stop once through the cranium and punctured the dura and grazed the cerebellum.It was also reported that surgery was completed successfully with minor time delays.

• 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: 5825807
• MDR Text Key: 50537327
• Report Number: 0001811755-2016-01292
• Device Sequence Number: 1
• Product Code: HBF
• Combination Product (y/n): N
• Reporter Country Code: GB
• 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: 07/19/2016

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: No Information
• Device Catalogue Number: 5100060001
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/05/2016
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/19/2016
• Initial Date FDA Received: 07/27/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 09/27/2016
• Was Device Evaluated by Manufacturer?: Yes
• 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
• Patient Age: 47 YR