MAUDE Adverse Event Report: STRYKER INSTRUMENTS-KALAMAZOO 5.0MM EGG BUR; BUR, SURGICAL, GENERAL & PLASTIC SURGERY

Model Number	0277010050
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/04/2020
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 that during a surgical procedure, the bur broke along the shank.It was also reported that there was a twenty minute delay as a result of this event.It was further reported that there were no adverse consequences as a result of this event and the procedure was completed successfully.
Event or Problem Description
It was reported that during a surgical procedure, the bur broke along the shank.It was also reported that there was a twenty minute delay as a result of this event.It was further reported that there were no adverse consequences as a result of this event and the procedure was completed successfully.
Additional Manufacturer Narrative
H6: the quality investigation is complete.

• Brand Name: 5.0MM EGG BUR
• Common Device Name: BUR, SURGICAL, GENERAL & PLASTIC SURGERY
• Manufacturer (Section D): STRYKER INSTRUMENTS-KALAMAZOO; 4100 east milham avenue; kalamazoo MI 49001
• MDR Report Key: 10922963
• Report Number: 0001811755-2020-03296
• Device Sequence Number: 1429038
• Product Code: GFF
• UDI-Device Identifier: 04546540468802
• UDI-Public: 04546540468802
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 01/18/2021

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: Health Professional
• Device Expiration Date: 06/01/2024
• Device Model Number: 0277010050
• Device Catalogue Number: 0277010050
• Device Lot Number: 19165017
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/26/2020
• Initial Date Received by Manufacturer: 11/04/2020
• Supplement Date Received by Manufacturer: 01/12/2021
• Initial Report FDA Received Date: 11/30/2020
• Supplement Report FDA Received Date: 01/18/2021
• 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: 4100120000, SN (B)(6); 4100120000, SN (B)(4)