MAUDE Adverse Event Report: STRYKER INSTRUMENTS-KALAMAZOO 3.0MM CRSE DMND ROUND, 13CM; DRILLS, BURRS, TREPHINES & ACCESSORIES

Catalog Number	8450012030DC
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/25/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Awaiting device evaluation.A follow up report will be filed once the quality investigation is complete.
Event or Problem Description
It was reported that during a spinal surgery, two burs twisted and broke.It was also reported that there was a fifteen minute delay to change burs as a result of this event.It was further reported that there were no adverse consequences and the procedure was completed successfully.This report is for the second bur that broke.
Event or Problem Description
It was reported that during a spinal surgery, two burs twisted and broke.It was also reported that there was a fifteen minute delay to change burs as a result of this event.It was further reported that there were no adverse consequences and the procedure was completed successfully.This report is for the second bur that broke.It was subsequently determined upon evaluation of the returned devices, that only 1 bur broke and 1 bur was bent.This report is for the bur that broke.
Additional Manufacturer Narrative
Investigation results indicate that the bur shows signs of heat marks and wear markings consistent with bearing malfunction of the attachment.It is possible that a bearing malfunction/failure has caused the part to break.It was subsequently determined upon evaluation of the returned devices, that only 1 bur broke and 1 bur was bent.

• Brand Name: 3.0MM CRSE DMND ROUND, 13CM
• Common Device Name: DRILLS, BURRS, TREPHINES & ACCESSORIES
• Manufacturer (Section D): STRYKER INSTRUMENTS-KALAMAZOO; 4100 east milham avenue; kalamazoo MI 49001
• MDR Report Key: 7994948
• Report Number: 0001811755-2018-01761
• Device Sequence Number: 18904336
• Product Code: HBE
• UDI-Device Identifier: 07613327096842
• UDI-Public: 07613327096842
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K143540
• 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): 12/05/2018

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: 05/01/2018
• Device Catalogue Number: 8450012030DC
• Device Lot Number: 18121017
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/22/2018
• Initial Date Received by Manufacturer: 09/27/2018
• Supplement Date Received by Manufacturer: 11/28/2018
• Initial Report FDA Received Date: 10/23/2018
• Supplement Report FDA Received Date: 12/05/2018
• 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: UNKNOWN ATTACHMENT