MAUDE Adverse Event Report: STRYKER INSTRUMENTS-KALAMAZOO 1.3MM WIRE PASS DRILL BIT; DRILLS, BURRS, TREPHINES & ACCESSORIES

Model Number	5820103013
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	04/10/2020
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 a craniotomy surgical procedure, it was noted that the drill broke inside the patient following consultation of the computed tomography(ct) scan.It was also reported that the fragment of the drill was removed successfully from the patient.It was further reported there were no delays and no adverse consequences as a result of this event.It was further reported that the procedure was completed successfully.
Event or Problem Description
It was reported that during a craniotomy surgical procedure, it was noted that the drill broke inside the patient following consultation of the computed tomography(ct) scan.It was also reported that the fragment of the drill was removed successfully from the patient.It was further reported 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
H6; the reported product involved with this event was returned for evaluation and the reported failure of breakage was confirmed.The product was evaluated by product engineering who concluded, from observations during device inspection, that the most likely cause of failure is that the drill encountered excessive force causing it to break at the shoulder transition location between the head and minor shank.The instructions for use for the attachments for use with the wire pass drill contain the following warning; "do not apply excessive pressure, such as bending or prying, with the cutting accessory.Excessive pressure may bend or fracture the cutting accessory.".

• Brand Name: 1.3MM WIRE PASS DRILL BIT
• Common Device Name: DRILLS, BURRS, TREPHINES & ACCESSORIES
• Manufacturer (Section D): STRYKER INSTRUMENTS-KALAMAZOO; 4100 east milham avenue; kalamazoo MI 49001
• MDR Report Key: 10043065
• Report Number: 0001811755-2020-01277
• Device Sequence Number: 2561468
• Product Code: HBE
• UDI-Device Identifier: 04546540362414
• UDI-Public: 04546540362414
• Combination Product (Y/N): N
• PMA/510(K) Number: K143320
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/20/2020

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: 07/01/2022
• Device Model Number: 5820103013
• Device Catalogue Number: 5820103013
• Device Lot Number: 19209017
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/09/2020
• Initial Date Received by Manufacturer: 04/13/2020
• Supplement Date Received by Manufacturer: 07/17/2020
• Initial Report FDA Received Date: 05/11/2020
• Supplement Report FDA Received Date: 07/20/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1