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	No Known Impact Or Consequence To Patient (2692)
Date of Event	07/30/2019
Type of Reportable Event	Serious Injury
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 not removed from the patient body.Otherwise, the procedure was reported as completed successfully.
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 not removed from the patient body.Otherwise, 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 with the fractured tip of the drill was not returned although it was reported that the fragment could be retrieved and did not remain in the patient.Further, it was determined that the cutting edge of the drill shows damages in form of plastic deformations.The different directions of these plastic deformations indicate multiple use of the drill in several cases.In addition, the drill helix shows material bulging from a foreign material resulting from collision and friction with a hard object (no bone), also an indication for multiple use of the drill.Moreover, the fracture surface shows the appearance of a forced rupture caused by too high torsional forces.Summarized, based on the investigation the root cause of the drill breakage was attributed to an inappropriate user handling.Multiple use of the drill in combination with the determined different damages of the cutting edges led finally to an overload situation and breakage of the drill.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.

• 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: 8947236
• Report Number: 0008010177-2019-00057
• Device Sequence Number: 2576198
• 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?: Yes
• 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: 08/29/2019
• 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
• Outcome Attributed to Adverse Event: Other