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

Catalog Number	8450107030DC
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/01/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A follow up report will be filed once the quality investigation is complete.Awaiting device return to manufacturer.
Event or Problem Description
It was reported that during an med (micro endoscopic discectomy) procedure, the bur broke along the shaft.It was also reported that there were no delays and no adverse consequences as a result of this event.It was further reported that the procedure was completed successfully.
Additional Manufacturer Narrative
Investigation results indicate that the returned bur experienced a high fluctuating axial force (heavy use) which increased the stress at the unsupported mid curved location of the bur.The ifu of attachments associated with this device warn the user against this type of use: "do not apply excessive pressure, such as bending or prying, with the cutting accessory.Excessive pressure may bend or fracture the cutting accessory." the quality investigation is complete.
Event or Problem Description
It was reported that during an med (micro endoscopic discectomy) procedure, the bur broke along the shaft.It was also reported that there were no delays and no adverse consequences as a result of this event.It was further reported that the procedure was completed successfully.

• Brand Name: 3.0MM CRSE DMND MTCH HD, 13CM
• Common Device Name: DRILLS, BURRS, TREPHINES & ACCESSORIES
• Manufacturer (Section D): STRYKER INSTRUMENTS-KALAMAZOO; 4100 east milham avenue; kalamazoo MI 49001
• MDR Report Key: 7550183
• Report Number: 0001811755-2018-01019
• Device Sequence Number: 283708
• Product Code: HBE
• UDI-Device Identifier: 07613327134650
• UDI-Public: 07613327134650
• Combination Product (Y/N): N
• 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): 08/02/2018

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: 11/01/2021
• Device Catalogue Number: 8450107030DC
• Device Lot Number: 16322017
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/06/2018
• Initial Date Received by Manufacturer: 05/07/2018
• Supplement Date Received by Manufacturer: 08/02/2018
• Initial Report FDA Received Date: 05/29/2018
• Supplement Report FDA Received Date: 08/02/2018
• 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: 5407120900 SN UNKNOWN; 5407120950C SN UNKNOWN