MAUDE Adverse Event Report: STRYKER INSTRUMENTS-KALAMAZOO 2.3MM SPIRAL ROUTER; DRILLS, BURRS, TREPHINES & ACCESSORIES

Catalog Number 5407FA2023SP

Device Problem Temperature Problem (3022)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/20/2016

Event Type  malfunction  

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 surgical procedure, the router got hot.It was further reported there was a minor delay of less than 30 minutes to obtain a replacement router as a result of this event.It was also reported that there were no adverse consequences and the procedure was completed successfully.

Manufacturer Narrative

The router & the associated attachment (5407fa2000 sn(b)(4)) was returned for evaluation.Upon visual evaluation, the router was hot in the attachment and the reported failure of heat was confirmed.Upon evaluation of the associated attachment (5407fa2000 sn(b)(4)), investigation results indicate that the front bearing was corroded and shattered.The presence of corrosion and shattered bearings may cause or contribute to the reported event.

Event Description

It was reported that during a surgical procedure, the router got hot.It was further reported there was a minor delay of less than 30 minutes to obtain a replacement router as a result of this event.It was also reported that there were no adverse consequences and the procedure was completed successfully.

• Brand Name: 2.3MM SPIRAL ROUTER
• 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: 5731951
• MDR Text Key: 47593123
• Report Number: 0001811755-2016-00832
• Device Sequence Number: 1
• Product Code: HBE
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K143399
• 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: 04/04/2017

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: 5407FA2023SP
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/23/2017
• 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