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	04/18/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A follow up report will be filed once the quality investigation is complete.
Event or Problem Description
It was reported via the sales representative that the bur broke during testing and was retained in the handpiece.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
A fragment of the device was returned for evaluation.The router reported broken in this event occurred during testing by the manufacturer.The definitive root cause could not be determined as only a partial piece of the device was returned.The quality investigation is closed.
Event or Problem Description
It was reported via the sales representative that the bur broke during testing and was retained in the handpiece.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: 8608126
• Report Number: 0001811755-2019-01680
• Device Sequence Number: 13976188
• Product Code: HBE
• UDI-Device Identifier: 07613327096736
• UDI-Public: 07613327096736
• Combination Product (Y/N): N
• Initial Reporter State: MD
• 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): 06/20/2019

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: Other
• Device Catalogue Number: 5407FA3030
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/23/2019
• Initial Date Received by Manufacturer: 04/18/2019
• Supplement Date Received by Manufacturer: 06/20/2019
• Initial Report FDA Received Date: 05/14/2019
• Supplement Report FDA Received Date: 06/20/2019
• 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: 5407300000, PI DRIVE PLUS MOTOR, (B)(4); 5407300000, PI DRIVE PLUS MOTOR, (B)(4)