MAUDE Adverse Event Report: STRYKER INSTRUMENTS-KALAMAZOO 3.0MM CRSE DMND MTCH HD, 16CM; DRILLS, BURRS, TREPHINES & ACCESSORIES

Catalog Number	8470107030DC
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/20/2017
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 mis lumber spine procedure, the bur broke along the shaft.It was also reported there were no adverse consequences as a result of this event.It was further reported that there was a five to ten minute delay to obtain an alternative device.It was also reported the procedure was completed successfully.
Additional Manufacturer Narrative
Investigation results indicate that some unusual markings were noted along the shank of the bur near the two fracture sites.There are markings consistent with the bearing location within the attachment.It was also noted that the markings on the bur shaft are consistent with markings made by a plyers type tool.From the location of the plyers markings on the bur shank this would align with the fracture occurring just above the notch which would have been locked into the hub.
Event or Problem Description
It was reported that during a mis lumber spine procedure, the bur broke along the shaft.It was also reported there were no adverse consequences as a result of this event.It was further reported that there was a five to ten minute delay to obtain an alternative device.It was also reported the procedure was completed successfully.

• Brand Name: 3.0MM CRSE DMND MTCH HD, 16CM
• Common Device Name: DRILLS, BURRS, TREPHINES & ACCESSORIES
• Manufacturer (Section D): STRYKER INSTRUMENTS-KALAMAZOO; 4100 east milham avenue; kalamazoo MI 49001
• MDR Report Key: 6331555
• Report Number: 0001811755-2017-00591
• Device Sequence Number: 817690
• Product Code: HBE
• UDI-Device Identifier: 07613327097238
• UDI-Public: (01)07613327097238
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K143540
• 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): 03/13/2017

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 Catalogue Number: 8470107030DC
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/03/2017
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 01/20/2017
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/15/2017
• Supplement Report FDA Received Date: 03/13/2017
• 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: 5407120970C (B)(4)