MAUDE Adverse Event Report: STRYKER LEIBINGER FREIBURG TWIST DRILL FOR 6514-7-200, DIAM.1.5X16MM, 5MM WORKING LENGTH; INSTRUMENT

Model Number	60-15995
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	07/30/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device has not yet been received at the manufacturer for testing.An evaluation will be conducted upon receipt of the device, and a follow-up report will be submitted after the quality investigation is complete.
Event or Problem Description
It was reported by a surgeon that a drill bit broke at the tip during a surgical procedure.The broken portion of the drill was removed from the patient body.The complainant was not aware of medical intervention or adverse consequences with this event, but the procedure was reported as completed successfully.
Additional Manufacturer Narrative
The reported event that the drill fractured could be confirmed.The visual inspection revealed that the drill helix fractured near the shaft.The broken off fragment could be retrieved and was also returned.Further, it was determined that the tip of the drill was heavily, plastically deformed in turn in and turn out direction resulting from high torsional forces in combination with high axial pressure during drilling.According to this, it was determined that the plastic deformations in turn out direction are stronger than in turn in direction.Also, the drill helix shows plastic deformations in form of material bulging resulting from collision and friction with a hard object ¿ no bone.Moreover, the fracture surface shows the appearance of a forced rupture caused by too high torsional forces.Most likely, due to the plastically deformed and not sharp cutting edge at the tip, the drill stopped working or got jammed during drilling in the bone.While trying to remove the drill the surgeon applied the power in reverse direction and caused the strong plastic deformation of the tip of the drill in turn out direction and finally the drill broke.Summarized, based on the investigation the root cause of the drill breakage was attributed to an inappropriate user handling.Indications for any material, manufacturing or design related issues were not found in the investigation.No preventive and/or corrective actions are deemed necessary at this time.
Event or Problem Description
It was reported by a surgeon that a drill bit broke at the tip during a surgical procedure.The broken portion of the drill was removed from the patient body.The complainant was not aware of medical intervention or adverse consequences with this event, but the procedure was reported as completed successfully.

• Brand Name: TWIST DRILL FOR 6514-7-200, DIAM.1.5X16MM, 5MM WORKING LENGTH
• Common Device Name: INSTRUMENT
• Manufacturer (Section D): STRYKER LEIBINGER FREIBURG; boetzingerstr. 41; freiburg D-791 11; DE D-79111
• MDR Report Key: 8935596
• Report Number: 0008010177-2019-00053
• Device Sequence Number: 2151572
• Product Code: HBE
• UDI-Device Identifier: 07613327090017
• UDI-Public: 07613327090017
• Combination Product (Y/N): N
• PMA/510(K) Number: K070876
• 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): 01/28/2020

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 Model Number: 60-15995
• Device Catalogue Number: 60-15995
• Device Lot Number: 6000076246
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/28/2019
• Initial Date Received by Manufacturer: 07/30/2019
• Supplement Date Received by Manufacturer: 07/30/2019
• Initial Report FDA Received Date: 08/27/2019
• Supplement Report FDA Received Date: 01/28/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1