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

Catalog Number 5100060001

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

Patient Problem No Patient Involvement (2645)

Event Date 05/20/2016

Event Type  malfunction  

Manufacturer Narrative

Awaiting device evaluation.A follow up report will be filed once the quality investigation is complete.

Event Description

It was reported that during testing of the perforator device prior to surgery, the perforator bit sounded like it was not going to stop.It was also reported that there was no patient involvement or adverse consequences as a result of this event.It was further reported that there was no associated procedure involved.

Manufacturer Narrative

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 testing of the perforator device prior to surgery, the perforator bit sounded like it was not going to stop.It was also reported that there was no patient involvement or adverse consequences as a result of this event.It was further reported that there was no associated procedure involved.

• 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: una barry ; instruments division; carrigtwohill bus. & tech park; carrigtwohill NA ; 214532900
• MDR Report Key: 5731824
• MDR Text Key: 47588190
• Report Number: 0001811755-2016-00830
• Device Sequence Number: 1
• Product Code: HBF
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K082010
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 02/08/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/17/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 5100060001
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/24/2016
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/12/2017
• 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