MAUDE Adverse Event Report: STRYKER INSTRUMENTS-A DIVISION OF STRYKER CORP 2.3MM SPIRAL ROUTER; DRILLS, BURRS, TREPHINES & ACCESSORIES

Model Number	5407FA2023SP
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/09/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A follow up report will be filed once the quality investigation is complete.Awaiting confirmation if device is available.
Event or Problem Description
It was reported that prior to a procedure it was noted the router was broken at the base in the associated 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: investigation results indicate that the router breakage is due to a bearing failure with the associated attachment, 5407fa2000 sn(b)(6).The quality investigation is complete.
Event or Problem Description
It was reported that prior to a procedure it was noted the router was broken at the base in the associated 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.

• Brand Name: 2.3MM SPIRAL ROUTER
• Common Device Name: DRILLS, BURRS, TREPHINES & ACCESSORIES
• Manufacturer (Section D): STRYKER INSTRUMENTS-A DIVISION OF STRYKER CORP; 1941 stryker way; portage MI 49002
• MDR Report Key: 11691685
• Report Number: 3015967359-2021-00449
• Device Sequence Number: 3073242
• Product Code: HBE
• UDI-Device Identifier: 07613327096712
• UDI-Public: 07613327096712
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K143399
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/26/2021

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: No Information
• Device Model Number: 5407FA2023SP
• Device Catalogue Number: 5407FA2023SP
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 03/24/2021
• Supplement Date Received by Manufacturer: 05/24/2021
• Initial Report FDA Received Date: 04/20/2021
• Supplement Report FDA Received Date: 05/26/2021
• 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, SN UNKNOWN; 5407FA2000, SN UNKNOWN; 5407300000, SN UNKNOWN; 5407FA2000, SN UNKNOWN