MAUDE Adverse Event Report: STRYKER INSTRUMENTS-KALAMAZOO 3.0MM TAPERED ROUTER; DRILLS, BURRS, TREPHINES & ACCESSORIES

Catalog Number	5407FA3030
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	12/14/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A follow up report will be filed once the quality investigation is complete.Router discarded.
Event or Problem Description
It was reported that during a product demonstration with the pi drive plus motor, the router broke.It was also reported that this event did not occur during a surgical procedure, and there was no delay or adverse consequences as a result of this event.
Additional Manufacturer Narrative
It was initially reported that the router was discarded, a partial piece was returned with the attachment.Investigation results concluded that as the router was loaded without the attachment.This could potentially cause the fracture of the router.A review of the associated attachment ifu 5407-210-768 rev-a noted the following warning; "note: cutting accessory labels are marked with a color stripe to facilitate cutting accessory selection.To select an appropriate cutting accessory, match the color stripe on the cutting accessory label with the color stripe on the attachment.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.".
Event or Problem Description
It was reported that during a product demonstration with the pi drive plus motor, the router broke.It was also reported that this event did not occur during a surgical procedure, and there was no delay or adverse consequences as a result of this event.

• Brand Name: 3.0MM TAPERED ROUTER
• Common Device Name: DRILLS, BURRS, TREPHINES & ACCESSORIES
• Manufacturer (Section D): STRYKER INSTRUMENTS-KALAMAZOO; 4100 east milham avenue; kalamazoo MI 49001
• MDR Report Key: 6239283
• Report Number: 0001811755-2017-00036
• Device Sequence Number: 368270
• Product Code: HBE
• UDI-Device Identifier: 07613327096736
• UDI-Public: (01)07613327096736(17)190701(10)16204017
• Combination Product (Y/N): N
• Initial Reporter State: MN
• 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
• Type of Report: Initial,Followup
• Report Date (Section B): 03/21/2017

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 Expiration Date: 07/01/2019
• Device Catalogue Number: 5407FA3030
• Device Lot Number: 16204017
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/29/2016
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 12/14/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/10/2017
• Supplement Report FDA Received Date: 03/21/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: (B)(4)