MAUDE Adverse Event Report: STRYKER INSTRUMENTS-KALAMAZOO 5.0MM MULTI-FLUTE ROUND; DRILLS, BURRS, TREPHINES & ACCESSORIES

Model Number	5820110050
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/29/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A follow up report will be filed once the quality investigation is complete.Awaiting device return.
Event or Problem Description
It was reported that during a surgical procedure, the bur broke and is stuck inside the attachment, no parts fell into the patient.It was also reported that there were no adverse consequences and no delays as a result of this event.It was further reported that the procedure was completed successfully.
Additional Manufacturer Narrative
Device not returned.
Event or Problem Description
It was reported that during a surgical procedure, the bur broke and is stuck inside the attachment, no parts fell into the patient.It was also reported that there were no adverse consequences and no delays as a result of this event.It was further reported that the procedure was completed successfully.

• Brand Name: 5.0MM MULTI-FLUTE ROUND
• Common Device Name: DRILLS, BURRS, TREPHINES & ACCESSORIES
• Manufacturer (Section D): STRYKER INSTRUMENTS-KALAMAZOO; 4100 east milham avenue; kalamazoo MI 49001
• MDR Report Key: 9745551
• Report Number: 0001811755-2020-00535
• Device Sequence Number: 13631697
• Product Code: HBE
• UDI-Device Identifier: 07613327294804
• UDI-Public: 07613327294804
• Combination Product (Y/N): N
• Initial Reporter Country: GB
• PMA/510(K) Number: K143320
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/28/2020

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: Health Professional
• Device Expiration Date: 06/01/2022
• Device Model Number: 5820110050
• Device Catalogue Number: 5820110050
• Device Lot Number: 19159017
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 01/29/2020
• Supplement Date Received by Manufacturer: 04/27/2020
• Initial Report FDA Received Date: 02/24/2020
• Supplement Report FDA Received Date: 04/28/2020
• 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: 5407120450 SN (B)(4)