MAUDE Adverse Event Report: STRYKER GMBH 3.0MM ASNIS MICRO, CANNULATED DRILL 2.1MM, AO COUPLING; BIT, DRILL

Model Number	45-30005S
Medical Device Problem Codes	Break (1069); Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/30/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Once the investigation has been completed, any additional information will be reported in a supplemental report.
Event or Problem Description
As reported, "instrument set: asnis micro 2.0/3.0 cannulated screws.While drilling with the 2.1mm drill over the 1.2mm wire that was inside the patient.The drill exploded and broke off inside the patient.The metal from the drill caused shards to break off into the drill guide causing it to be unusable, and extra time was spent removing the broken drill from the patient.Update on (b)(6) 2023.5 minute delay to extract drill/debris.All debris was removed.Procedure was successfully completed by placing a screw in the drill hole after removing debris from drill.
Event or Problem Description
As reported: "instrument set: asnis micro 2.0/3.0 cannulated screws.While drilling with the 2.1mm drill over the 1.2mm wire that was inside the patient the drill exploded and broke off inside the patient.The metal from the drill caused shards to break off into the drill guide causing it to be unusable and extra time was spent removing the broken drill from the patient.Update on 07 apr 2023: 5 minute delay to extract drill/debris, all debris was removed, procedure was successfully completed by placing a screw in the drill hole after removing debris from drill.
Additional Manufacturer Narrative
The reported event could be confirmed, since the drill bit is broken as complained.The device inspection revealed the following: the visual inspection has shown that the drill bit is broken twice.A fragment of the drill bit with a length of about 1cm is stuck in the drill guide.But there is no indication that the drill guide did contribute to the breakage of the drill.The initial deformation with subsequent breakage occurred at the cutting flutes at the forefront of the drill bit, this damage caused a jamming of the drill bit in the guide with a secondary breakage above the jammed section.A microscopic inspection was performed.There are in the area of the initial breakage some nicks and deformations at the cutting edge visible, this could be an indication for a metallic contact.The fracture face has the typical view of a ductile overload fracture where the applied force did lead to a permanent distortion of the material with a subsequent fracture.A review of the device history for the reported lot did not indicate any abnormalities.No corrective actions are required at this time.A review of the labeling did not indicate any abnormalities.No indications of material, manufacturing or design related problems were found during the investigation.No product related issue could be detected.Based on the available information it is not possible to determine the exact root cause of this complaint.A previous investigation with a similar damage pattern has shown that a potential cause could be a excessive contact with another guide wire which crosses the path of the drill bit during drilling.If more information is provided, the case will be reassessed.

• Brand Name: 3.0MM ASNIS MICRO, CANNULATED DRILL 2.1MM, AO COUPLING
• Common Device Name: BIT, DRILL
• Manufacturer (Section D): STRYKER GMBH; bohnackerweg 1; postfach; selzach 2545 ; SZ 2545
• Manufacturer (Section G): STRYKER LEIBINGER FREIBURG; boetzingerstr. 41; freiburg D-791 11; GM D-79111
• Manufacturer Contact: anna jusinski ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 16827305
• Report Number: 0008031020-2023-00166
• Device Sequence Number: 1929685
• Product Code: HTW
• UDI-Device Identifier: 04546540534217
• UDI-Public: 04546540534217
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• 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): 07/25/2023

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: 45-30005S
• Device Catalogue Number: 45-30005S
• Device Lot Number: AM11/EA
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/17/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/30/2023
• Supplement Date Received by Manufacturer: 06/28/2023
• Initial Report FDA Received Date: 04/27/2023
• Supplement Report FDA Received Date: 07/25/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/30/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Age: 23 YR
• Patient Sex: Female