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

Model Number	5407FA2023SP
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	06/15/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A follow up report will be filed once the quality investigation is complete.Awaiting return of device to manufacturer.
Event or Problem Description
It was reported that during testing, prior to a surgical procedure, it was noted that the bur was broken in the attachment.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.
Event or Problem Description
It was reported that during testing, prior to a surgical procedure, it was noted that the bur was broken in the attachment.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
H6; the reported event, for router breakage, was confirmed, a partial piece of the router was returned for evaluation.As only a partial piece of the router was returned further evaluation of this partial piece of the router was not possible.As a result a cause for the router breakage could not be determined in this case.

• 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: 10257319
• Report Number: 0001811755-2020-01657
• Device Sequence Number: 11337177
• Product Code: HBE
• UDI-Device Identifier: 07613327096712
• UDI-Public: 07613327096712
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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): 08/27/2020

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 Model Number: 5407FA2023SP
• Device Catalogue Number: 5407FA2023SP
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/17/2020
• Initial Date Received by Manufacturer: 06/15/2020
• Supplement Date Received by Manufacturer: 08/27/2020
• Initial Report FDA Received Date: 07/10/2020
• Supplement Report FDA Received Date: 08/27/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1