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

Model Number	5407FA2023SP
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	04/16/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A follow up report will be filed once the quality investigation is complete.Awaiting device return to manufacturer.
Event or Problem Description
It was reported that during a posterior cervical bilateral laminectomy, the router broke into three pieces.It was also reported that there were no delays and no adverse consequences as a result of this event.It was further reported that the procedure was completed successfully.
Additional Manufacturer Narrative
Investigation results indicate that the most likely cause of failure is the attachment lock not correctly loaded or locked into the attachment.The ifu for the attachment (5407-210-768 rev-b) has the following warning; " while aligning the dots on the attachment and motor, slide the attachment over the cutting accessory and onto the motor until it snaps into place.Warning: operating the motor without the attachment securely connected and cutting accessory securely locked may result in patient or healthcare staff injury.Gently tug the attachment to verify it is secure." the quality investigation is complete.
Event or Problem Description
It was reported that during a posterior cervical bilateral laminectomy, the router broke into three pieces.It was also reported that there were no delays and no adverse consequences as a result of this event.It was further reported that the procedure was completed successfully.

• Brand Name: 2.3MM SPIRAL ROUTER
• Common Device Name: DRILLS, BURRS, TREPHINES & ACCESSORIES
• Manufacturer (Section D): STRYKER INSTRUMENTS-KALAMAZOO; 4100 east milham avenue; kalamazoo MI 49001
• MDR Report Key: 7495286
• Report Number: 0001811755-2018-00964
• Device Sequence Number: 1313989
• Product Code: HBE
• UDI-Device Identifier: 07613327096712
• UDI-Public: (01)07613327096712
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K143399
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/13/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 5407FA2023SP
• Device Catalogue Number: 5407FA2023SP
• Device Lot Number: 16147037
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/10/2018
• Initial Date Received by Manufacturer: 04/16/2018
• Supplement Date Received by Manufacturer: 06/12/2018
• Initial Report FDA Received Date: 05/08/2018
• Supplement Report FDA Received Date: 06/13/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1