MAUDE Adverse Event Report: STRYKER LEIBINGER FREIBURG 1.5X110MM DRILL, 20MM WL, COLOR DEPTH MARKS; INSTRUMENT

Model Number	60-15620
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Codes	No Known Impact Or Consequence To Patient (2692); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/24/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device has been received at the manufacturer for testing.An evaluation will be conducted, and a follow-up report will be submitted after the quality investigation is complete.
Event or Problem Description
It was reported by a company representative that the device snapped as the surgeon was pulling the drill bit out and the other became stuck in the bone as they were drilling in the mandible and snapped off of the shaft.Drill fragments were retrieved from the patient.No other information is known at this time.
Additional Manufacturer Narrative
The reported event that two drills fractured could not be confirmed because they were not available for investigation (lost in transit).Therefore, a metallurgical examination of the reported breakage cannot be performed, and it is also not possible to determine the precise root cause.According to previous similar performed investigations the possible root causes could have been: generally ¿ overload condition; reused drill in multiple surgeries; wrong speed for drilling; no axial guidance.Based on statistical evaluation there are no indications for any product related issue.Therefore, no corrective and/or preventive action is deemed to be necessary at this moment.Product surveillance will continue to monitor complaints of this type for adverse trends and the complaint is added to the complaint trend.If the products could be located at a later date an appropriate investigation will be performed, the complaint re-opened and the result revised.Device was not returned for evaluation.
Event or Problem Description
It was reported by a company representative that the device snapped as the surgeon was pulling the drill bit out and the other became stuck in the bone as they were drilling in the mandible and snapped off of the shaft.Drill fragments were retrieved from the patient.No other information is known at this time.

• Brand Name: 1.5X110MM DRILL, 20MM WL, COLOR DEPTH MARKS
• Common Device Name: INSTRUMENT
• Manufacturer (Section D): STRYKER LEIBINGER FREIBURG; boetzingerstr. 41; freiburg D-791 11; GM D-79111
• MDR Report Key: 10404883
• Report Number: 0008010177-2020-00042
• Device Sequence Number: 3669060
• Product Code: HBE
• UDI-Device Identifier: 04546540695086
• UDI-Public: 04546540695086
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K070876
• 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): 12/04/2020

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: 60-15620
• Device Catalogue Number: 60-15620
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 07/24/2020
• Supplement Date Received by Manufacturer: 07/24/2020
• Initial Report FDA Received Date: 08/13/2020
• Supplement Report FDA Received Date: 12/05/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1