MAUDE Adverse Event Report: STRYKER INSTRUMENTS-KALAMAZOO UNKNOWN_INSTRUMENTSTIRE_PRODUCT; DRILLS, BURRS, TREPHINES & ACCESSORIES

Catalog Number UNK_ICO

Device Problem Failure to Auto Stop (2938)

Patient Problem Abrasion (1689)

Event Date 02/22/2018

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.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.Device not returned for evaluation.

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.No further information was provided.

• Brand Name: UNKNOWN_INSTRUMENTSTIRE_PRODUCT
• 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: 7366505
• MDR Text Key: 103331975
• Report Number: 0001811755-2018-00533
• Device Sequence Number: 1
• Product Code: HBF
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: UNK
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,other
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 05/24/2018

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: UNK_ICO
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/23/2018
• Initial Date FDA Received: 03/23/2018
• Supplement Dates Manufacturer Received: 05/04/2018
• Supplement Dates FDA Received: 05/24/2018
• Was Device Evaluated by Manufacturer?: No
• 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): Required Intervention