MAUDE Adverse Event Report: STRYKER INSTRUMENTS-KALAMAZOO 2.5MM PRCSN MTCH HD, 16CM; DRILLS, BURRS, TREPHINES & ACCESSORIES

Catalog Number	8470107525
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/01/2019
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 minimally invasive discectomy the distal portion of the bur broke off from the drill attachment while the surgeon was drilling.It was also reported that the broken piece was removed using irrigation, an x-ray confirmed there were no other fragments in the patient.It was further reported that there was a delay of five minutes as a result of this event.It was also reported that there were no adverse consequences and the procedure was completed successfully.
Event or Problem Description
It was reported that during a minimally invasive discectomy the distal portion of the bur broke off from the drill attachment while the surgeon was drilling.It was also reported that the broken piece was removed using irrigation, an x-ray confirmed there were no other fragments in the patient.It was further reported that there was a delay of five minutes as a result of this event.It was also reported that there were no adverse consequences and the procedure was completed successfully.
Additional Manufacturer Narrative
The definitive root cause could not be determined as only a partial piece of the device was returned.The quality investigation is closed.

• Brand Name: 2.5MM PRCSN 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: 8826343
• Report Number: 0001811755-2019-02564
• Device Sequence Number: 2859634
• Product Code: HBE
• UDI-Device Identifier: 07613327097184
• UDI-Public: 07613327097184
• Combination Product (Y/N): N
• Initial Reporter State: IA
• Initial Reporter Country: US
• PMA/510(K) Number: K143540
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 09/17/2019

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: 8470107525
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/10/2019
• Initial Date Received by Manufacturer: 07/01/2019
• Supplement Date Received by Manufacturer: 09/17/2019
• Initial Report FDA Received Date: 07/25/2019
• Supplement Report FDA Received Date: 09/17/2019
• 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 SN (B)(4); 5407120970C SN (B)(4)