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	Material Frayed (1262); Material Deformation (2976)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	12/09/2022
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: "stryker drill bit was noted by doctor to have frayed/untwisted during use.Drill bit was removed from the sterile field and service coordinator notified to initiate product failure process." it is unknown if there was any debris left in the patient.
Event or Problem Description
As reported: "stryker drill bit was noted by doctor to have frayed/untwisted during use.Drill bit was removed from the sterile field and service coordinator notified to initiate product failure process." it is unknown if there was any debris left in the patient.
Additional Manufacturer Narrative
Please note the correction to d9/h3 as the device was not returned for evaluation.The reported event could not be confirmed, since the device was not returned and no additional information was available.A device inspection was not possible since the affected device was not returned and no other evidences were provided for investigation.A review of the device history was not possible because the lot number was not communicated.No corrective actions are required at this time.A review of the labeling did not indicate any abnormalities.More detailed information about the complaint event must be available in order to determine the root cause of the complaint event.If any further information is provided or the device is returned, the complaint report will be updated.H3 other text : device disposition unknown.

• 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: 16308855
• Report Number: 0008031020-2023-00046
• Device Sequence Number: 17843298
• Product Code: HTW
• UDI-Device Identifier: 04546540534217
• UDI-Public: 04546540534217
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial,Followup
• Report Date (Section B): 03/23/2023

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: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/13/2023
• Supplement Date Received by Manufacturer: 02/27/2023
• Initial Report FDA Received Date: 02/06/2023
• Supplement Report FDA Received Date: 03/23/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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: 73 YR
• Patient Sex: Female